A Loss of Twins and Missed Opportunities for Cerclage

Recently, a reader left the comment below. The value and use of cervical cerclage continues to come into question. There are major institutions in this country where it is not considered to be a useful procedure and have abandoned or severely limited its use to selective patients in deference to ‘conservative management’, often now involving the administration of progesterone during the pregnancy. I have addressed my feelings on cerclage in a series published on this site many months ago (between August 18 and September 26, 2008). My feelings have not changed. There is a big difference between getting a couple of extra weeks to an extremely early pregnancy, or holding off delivery long enough to ‘get steroids on board’ for fetal lung maturation, and delivering a baby beyond 30 weeks gestation when the risk of long-term complications of prematurity are greatly diminished. Barely a week goes by on our service when a patient would have lost a pregnancy in the manner detailed below except for the timely recognition of cervical insufficiency and the placement of a cerclage in later midtrimester…

On June 10 Anonymous wrote:
I have read one of your previous articles regarding cervical cerclage. I was diagnosed with endometriosis, treated with laproscopy and subsequently underwent many IUIs and one cycle of IVF without success. My second IVF cycle was successful, but due to preterm premature rupture of membranes (PPROM) at 21 weeks, lost healthy twins. No history of diabetes or hypertension. Doctors could not diagnose the reason for PPROM, may be due to cervical incompetence. I was on total bed rest, but had some vaginal bleeding at 11 weeks. I just wanted to know if cervical incompetence could have been diagnosed before and cervical cerclage would have been useful. What are my chances of undergoing normal conception?

To anonymous June 10:
Conception and successful carriage of a pregnancy are separate issues. It sounds like you had (and may still have) cervical insufficiency with the twin pregnancy. I firmly believe that all multiple gestations, particularly those resulting in infertility patients, should be carefully evaluated for premature cervical changes by transvaginal ultrasound beginning as early as 16 weeks. If cervical changes were picked up early enough, a cerclage may well have been successful in preventing your pregnancy loss.

Twenty-five years ago, detecting and treating cervical incompetence in a 'first pregnancy' was rarely successful. The diagnosis of cervical incompetence (insufficiency) was a diagnosis of exclusion, usually after one or more premature deliveries or midtrimester pregnancy losses. But because of the increased surveillance by ultrasound, it is almost a weekly event on our service.

With a subsequent pregnancy, I would recommend serial cervical evaluation by ultrasound even if you have a single baby. You might also be a candidate for an elective/prophylactic cerclage at 13-14 weeks if you have any other risk factors such as a congenital uterine abnormality or previous cervical surgery (e.g., LEEP or conization). In addition, even if you and your providers decide only upon serial ultrasound evaluation, you might consider weekly injections with 17-OH-progesterone caproate beginning at 16-18 weeks as well. I am sorry for your loss, but with careful follow-up and pregnancy management, you should be successful in the future.
Kind regards,
Dr T

Labels: 17-hydroxyprogesterone caproate, 17P, cerclage, cervical incompetence, cervical insufficiency; premature labor

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Cervical Incompetence and Cerclage - 11 - Rescue Cerclage (2)

A 17 year old primigravida was sent on referral when she was found to have significant “ballooning” of the membranes into the cervical canal at 20 2/7 weeks gestation. She was obese and a smoker but otherwise had an unremarkable medical and pregnancy history to that point. She reported some spotting after intercourse 2 days earlier and cramping lower abdominal pain and “pressure” during her transfer to our hospital, but denied fever, chills, constant pain, frank bleeding, leakage of fluid, or symptoms of urinary tract infection. On admission, the patient was found to be having irregular uterine contractions, the uterus was nontender, and the membranes were intact. She did not have a fever. Her cervix was 4-5 cm dilated, “completely” effaced, and membranes were bulging at the external cervical os.

She was begun on IV antibiotics (the same “cocktail” mentioned in my last post) and also started on magnesium sulfate. A Foley catheter was placed in her bladder. Her white blood count was noted to be mildly elevated at 14,300 but the differential was normal. Her urine analysis and, subsequently, a culture were negative as were cervical cultures for gonorrhea and Chlamydia. She remained stable overnight on the magnesium sulfate and antibiotics with no further change in her cervix. At that point we had a frank discussion regarding the potential risks and benefits of attempting to place a cerclage with which she elected to proceed with the comment “what have I got to lose by trying at this point anyway.” Points of the counseling did include that the procedure would be risky and that the chances for success were low and that it could precipitate delivery, but that delivery seemed imminent regardless and the baby was remote from good viability…

1) The patient was given an oral dose of indomethacin 100 mg and taken to the operating room

2) As she was receiving her fluid bolus for the spinal anesthetic, the Foley catheter was clamped off

3) She was prepped (but not deeply in the vagina) and draped

4) A weighted speculum was placed in the vagina and the cervix visualized with retractors

5) The cervix was noted to be at least 4-5 cm dilated and 100% effaced with membranes bulging at the external cervical os – indeed, with each breath she took, the membranes appeared to be ready to completely prolapse into the vagina – and the fetal head was visible above the membranes

6) The rest of the vagina was then gently prepped with betadine solution, avoiding direct contact with the membranes

7) The cervix was grasped on its anterior lip with a sponge stick and drawn slightly downward

8) A suture of #1 chromic was then placed very superficially around the cervix, starting and ending at the 12:00 o’clock position 1 to 1.5 cm up the cervix

9) This was gently cinched up (without pushing directly on the membranes, and when the knot was being tied, just before the cervix was closed, a Foley catheter was placed into the cervical canal - the knot was then tied securely and the Foley bulb inflated

10) The cervix was then grasped on its anterior lip again and a cerclage was placed using a double-strand #5 Ethibond beginning at the 12 o'clock position approximately 1 to 1.5 cm above the initial stitch

11) When the 12 o'clock position was reached, this was cinched up and then tied as described in our previous posts, deflating and removing the Foley catheter, just as the knot was being tightened

12) The chromic suture placed initially was then cut out of the cervix

13) The vagina was irrigated with warm saline and then dried

14) The Foley catheter draining the bladder was then released, allowing the bladder to drain freely

15) There was no evidence of ruptured membranes at the conclusion of the procedure and the final cerclage was approximately 2.5 cm up the cervix

16) The external cervical os was still patulous but membranes were restored to above the level of the cerclage and less than 0.5 cm diameter of cervical canal was left

17) Following the procedure, the patient was continued on magnesium sulfate for 24 hours, placed on indomethacin 50 mg q6h for 72 hours, cefazolin 2.0 g q6h pending results of the urine culture obtained at admission, azithromycin 500 mg per day for 5 days, and metronidazole 500 mg tid intravenously until discharge

18) She was discharged 4-5 days postoperatively to modified bedrest at home on metronidazole 500 mg bid and is still pregnant a month following her cerclage

One of the points I did not mention earlier is that during our preoperative discussion, the patient was told if the membranes completely prolapsed into the vagina before or after starting the procedure, I probably would not continue with the operation. Although techniques, such as pushing on the membranes with a moistened sponge and performing an amniocentesis to decompress the uterus, have been used successfully under these circumstances (and I have done so on occasions in the past when patients asked that “everything possible be done”), the risk for rupturing membranes and infection are so high during and after the procedure, I have leaned toward using this a ‘deal breaker’ when the pregnancy is so remote from a reasonable outcome for the baby. And, it should also be mentioned, that one condition always discussed with the patient, and must be agreed to before I attempt to place a rescue cerclage, is that anytime following the procedure they develop clear evidence of intrauterine infection, they must allow me to remove the cerclage and proceed with delivery.

Using the management protocols, surgical techniques, and criteria we have outlined in the last two posts, we have actually achieved ‘success’ rates (in terms of pregnancy prolongation to ‘good viability’, generally in excess of 28 weeks and minimal, if any, maternal or fetal morbidity) in more than 95% of our cases of rescue cerclage.

Labels: cerclage, cervical incompetence, cervical insufficiency; premature labor

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Cervical Incompetence and Cerclage - 10 - Rescue Cerclage

In my last post, I detailed my approach to placement of a prophylactic cerclage. Now let’s make things a little more challenging and discuss ‘rescue’ or ‘emergency’ cerclage. Actually, these usually fall into two broad categories, challenging and heroic! The challenging ones have funneling of the membranes to just inside or even just at the external cervical os and may be accompanied by dilation of the cervix as much as 2-3 cm; the heroic ones have more advanced dilation and effacement of the cervix with membranes bulging at, and slightly through, or completely prolapsed through the external cervical os. Let me give you a couple of case examples to help illustrate my differences in management under these two situations.

The first patient is a 35 year old woman who had primary infertility problems related to polycystic ovary syndrome. She is oligoovulatory, overweight, mildly hypertensive, somewhat androgenized, has insulin resistance (but not overt pregestational diabetes), and finally conceived after 3 months of metformin therapy followed by ovulation induction and intrauterine insemination. She had first trimester screening for aneuploidy done at 12 weeks because of her age (which she passed with flying colors) and returned at 20 weeks for a genetic sonogram. The baby looked wonderful, but during the course of the abdominal examination, the sonographer thought she saw ballooning of the membranes into the cervix. We performed a transvaginal ultrasound and the membranes were found to be ballooning to within 3-4 mm of the external os without any fundal compression. In discussion with the patient, she reported some pelvic “pressure” and had noted an increase in clear, mucous discharge, but reported no bleeding, cramping pain, or gross rupture of membranes. She had no fever or uterine tenderness. She was admitted that day for cerclage placement. I intentionally did NOT perform a bimanual pelvic examination on her in the office. So, how was her case handled…

1) She was admitted to our surgical unit on L&D

2) Urine analysis and culture and CBC with differential were sent

3) An IV was placed and the patient was given an antibiotic cocktail (after obtaining the urine culture) of cefazolin 2.0 g q6h, azithromycin 500 mg, and metronidazole 500 mg q6h

4) She was also given indomethacin 100 mg by mouth

5) She was taken to the operating room and given a spinal anesthetic

6) The patient was placed in the dorsal lithotomy position and the perineum and vagina (very gently) prepped with a betadine solution

7) After the patient was prepped and draped, a foley catheter was placed, the foley was clamped so that urine would not drain from the bladder, and the bag draped over her leg so as to be out of the operative field

8) A weighted speculum was placed in the vagina and the cervix was visualized with retractors

9) She was noted to be visibly dilated 1-2 cm and membranes could be seen approximately 4-5 mm inside the external cervical os, correlating well with the ultrasound findings

10) A cerclage was then placed approximately 2.5-3 cm above the external os following the exact procedure I reported in Steps 11 to 20 in our last post

11) The foley catheter was then unclamped and allowed to drain

12) As is so often the case in these circumstances, as the bladder filled, and as the cerclage was placed around the cervix, the membranes retracted higher into the cervical canal without having to be displaced by any instrumentation or insertion of a finger into the cervical canal (Personally, I think avoiding manipulation of the membranes may be very important to the success of rescue cerclages)

13) The patient was taken from the operating room and admitted overnight

14) The foley catheter was left in place

15) The cefazolin 2 g q6h, metronidazole 500 mg q6h, and indomethacin 50 mg q6h were continued overnight

16) The foley was removed the next morning and the patient was asked to void on her own before discharge

17) She was given a prescription for indomethacin 50 mg q 6 hour to complete a 72 hour course, azithromycin 250 mg daily for 4 days, and metronidazole 500 mg twice daily (to be continued until at least 30 weeks); she was placed on a stool softener and discharged to home with instructions for modified bedrest for 72 hours and then no intercourse or heavy exertional activity

18) She was scheduled for a transvaginal ultrasound 2 weeks following the procedure to assess cervical length and the level of the cerclage placement and told to return sooner with pain, cramping bleeding, rupture of membranes, or fever

19) When she returned, the transvaginal ultrasound showed the cerclage to be placed more than halfway up her cervix with another 1.5 cm of cervical canal free of membranes above the level of the cerclage. She still had V-shaped funneling at the level of the internal cervical os. Cervical evaluation was performed every other week until 28 weeks.

20) The metronidazole was discontinued at 30 weeks, but she subsequently developed a bacterial vaginosis-like discharge (commonly seen with cerclages) and she resumed the metronidazole until delivery.

21) During the course of her pregnancy, she developed insulin-dependent gestational diabetes and was eventually delivered after removal of the cerclage at 37 weeks when she underwent induction of labor for preeclampsia.

In our next post, we will discuss the approach to cerclage placement in a slightly more challenging case….

Labels: cerclage, cervical incompetence, cervical insufficiency; premature labor

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Cervical Incompetence and Cerclage - 9 - My Approach to Prophylactic Cerclage

At the end of my last post, I mentioned that the McDonald cerclage procedure is the type I have preferred for many years for most routine and ‘rescue cerclages’, but I also mentioned that if the suture is not placed highly enough, deeply enough, or tied tightly enough, it is at risk for failure. The first caveat, “highly enough,” is readily apparent but still often not done adequately. When I explain this to patients, I ask them to approximate the tips of their thumb and index fingers on one hand and imagine this to be the cervix with the surface of contact being the cervical canal. Then take the other thumb and index finger and squeeze the first two together. By compression even 2 cm up our surrogate cervix, and squeezing snugly, we can restore 3 to 4 cm of ‘cervical length.’

“Deeply enough” and “tightly enough” were technical components of good cerclage placement that I learned on my own early in my career and were actually contrary, especially the latter, to the classical approach to cerclage placement that I had been taught. I found that by placing the cerclage deeply into the cervical stroma, it is much more secure, less likely to dislodge, and goes beneath the major blood supply to the cervix so that when you tie the knot “tightly enough”, you do not run the risk of strangulating the cervix. Indeed, when I was originally taught to perform a cerclage I was specifically instructed never to tie the knot too tightly and to place either a finger or a small diameter dilator into the cervical canal and to tie the knot down against that. “Don’t close up an abscess” was the mantra that was drilled into my head. But, as I soon learned, patients with true cervical insufficiency would use the opportunity of the slight opening this left in the cervical canal to eventually ‘balloon’ their membranes past the point of the cerclage.

With these points in mind, my step-by-step approach to cerclage placement in the patient who is having this done prophylactically at 13-14 weeks is the following:

1) Perform an ultrasound and offer combined first trimester screening for aneuploidy at 11-12 weeks

2) Evaluate the cervix by speculum examination to determine the amount of cervix present in the vagina (portio vaginalis)

3) During the latter, send diagnostic studies for Chlamydia and gonorrhea if appropriate and evaluate the vaginal fluid for evidence of bacterial vaginosis

4) Evaluate the urine for evidence of a urinary tract infection

5) Treat any cervical, vaginal, or urinary tract infections before cerclage placement

6) Prophylactic antibiotics and tocolytic agents are usually not used for prophylactic early cerclages

7) The procedure itself is usually performed under regional (epidural or spinal) anesthesia

8) The patient is placed in the dorsal lithotomy position and the perineum and vagina prepped with a betadine solution

9) The bladder is emptied or a foley catheter is placed after the patient is prepped

10) A weighted speculum is placed in the vagina and the cervix is visualized with retractors – good assistance and visualization is very important to adequate cerclage placement

11) The cervix is grasped at the 12:00 o’clock position with a sponge stick and downward traction applied to ascertain the junction between the vaginal mucosa and the cervix – in and out movement of the sponge stick while holding the cervix can help to readily identify this anatomical landmark

12) A double-strand of #5 Ethibond is loaded on a free CT-1 needle and the tails are together held with a hemostat

13) Using the edge of the needle to push up on the junction between the cervix and vaginal mucosa (this will often give an additional cm or more of cervical length) the cerclage is begun at the 12:00 o’clock position by deeply seating (about two-thirds of the depth of the cervical stroma) the suture, angling the needle somewhat cephalad with each ‘bite’ of the cervix, and exiting between 9:00 and 10:00 o’clock.

14) The sponge stick is then moved to 9:00 o’clock, the retractors are repositioned, the next ‘bite’ of the cervix is begun right where the needle last exited (being careful not to place the needle between the double-strand of suture), and then exited between 7:00 and 8:00 o’clock.

15) The next stitch is VERY important (and also very risky once there has been cervical change later in the pregnancy). The cervix is grasped at 6:00 o’clock and the cervix pulled upward, retractors repositioned, and the next bite is placed as high as possible posteriorally on the cervix exiting between the 4:00 and 5:00 o’clock positions.

16) Movement of the sponge stick to 3:00 o’clock is done, the next stitch exited at 2:00 to 3:00 o’clock and then one more time brings the suture back to the 12:00 o’clock position (As you can see, I typically use a “five point” approach to cerclage placement with significant support brought to the posterior aspect of the cervix)

17) The next step is also VERY important. Before tying the knot, I cinch the suture material up snugly by grasping both ends of the suture and moving it through the tissue 3-4 times, seating the suture material even more deeply

18) I then tie the knot TIGHTLY with 6-7 knots – enough to cause slight cyanosis of the cervix before I leave the operating room

19) Irrigate the vagina with warm (not hot) saline (not squirting this into the cervical canal) and then DRY the vagina completely with sponges

20) The cervix should be slightly cyanotic at this point and ‘pouting’ at you; if the cerclage is well-placed, this pouting should be very symmetrical

21) The patient is not discharged until she can void on her own (and I will often leave the catheter in place until her full sensation to void has returned to avoid overdistention of the bladder and a call from the operating room nurse informing me that the patient has “ruptured membranes,” usually leaking urine from an overly full bladder)

22) The patient is given a prescription for ibuprofen 600 mg q 6 hour, instructed to use this for the expected cramping sensation she will experience, and told to call if she needs to use the medication for more than 72 hours.

23) She is scheduled for a tranvaginal ultrasound 2-3 weeks following the procedure to assess cervical length, integrity at the internal os, and the level of the cerclage placement

I fully realize that some components of my approach to cerclage placement may be controversial, but I can assure all of you who read this that this approach has worked well and has been accompanied by virtually no complications in the prophylactic cerclages I have performed for more than 20 years. In the next post, I will go through my approach to ‘rescue cerclage’ placement….

Labels: cerclage, cervical incompetence, cervical insufficiency; premature labor

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Cervical Incompetence and Cerclage - 8 - Shirodkar vs McDonald Cerclage

I just realized that since the outset of this series, we have talked about cervical cerclage but we have not explained what that is for the general reader. A cerclage is a ‘stitch’ placed around the cervix in a fashion that will, hopefully, prevent progressive cervical change and/or ballooning of the membranes through the cervical canal. There are various types of cerclages, but the three with which I have had the most experience can be found in our literature by the names Shirodkar cerclage, McDonald cerclage, and abdominal cerclage.

When I trained, we were almost exclusively taught to perform a Shirodkar cerclage (Antiseptic 1955;52:299). This procedure is done by dissecting the vaginal mucosa and bladder off the cervix anteriorally, and if necessary, opening the cul-de-sac (dissecting the vaginal mucosa off the cervix) posteriorally and then placing the suture as high as possible around the cervix tunneling through the cervical stroma. The cerclage is usually begun at the 12:00 o’clock position and then placed circumferentially with as few exit points as possible until the starting point is reached and the suture is tied. The vaginal mucosa is then reapproximated to cover the cerclage.

The procedure was first described by Shirodkar using absorbable catgut suture, but this was soon replaced with Mersilene tape – the ‘permanent’ material still most often used for this procedure today. The advantage of the Shirodkar cerclage is that one can place the suture almost as high (if not as high) as the internal cervical os. However, the disadvantages are that it is a more challenging procedure (especially with obese, primigravida patients or those with advanced cervical changes), often requiring more time in the operating room, with greater risk for hemorrhage, and perhaps infection, using a material that is sometimes more difficult to pass through the cervical tissue, and certainly more difficult to remove. Indeed, many patients with successful pregnancies and ‘good’ Shirodkars simply have a cesarean section performed for delivery and leave the original suture in place for a subsequent pregnancy. It is not a very practical procedure for ‘emergent’ or ‘rescue’ procedures when the membranes are deep in the cervical canal or ballooning past the external cervical os.

From my perspective, I mention the Shirodkar almost for historical purposes since most of the cerclages I have performed over the past 20-odd years have been McDonald cerclages. This procedure was described by McDonald (J Obstet Gynaecol Br Empire 1957;64:356) a few years after Shirodkar. It does not involve dissection of the vaginal mucosa off the cervix and is simply a ‘purse string’ suture placed around the cervix in 4 to 6 ‘bites’. Again, when I was first taught this procedure, I used Mersilene tape, but soon learned that the disadvantages, for the reasons noted above, made this suture material especially impractical when a ‘rescue’ procedure was necessary – something I was being called upon to perform more often in my consulting role in Maternal-Fetal Medicine. Indeed, despite taking great care, I remember iatrogenically rupturing membranes several times during ‘rescue’ procedures simply as the result of the difficulty of tightening the mersilene tape around the cervix after the cerclage had been placed. As the result of these experiences, I switched to #5 Ethibond and have used this successfully for more than 20 years as will be described in our next post.

The primary advantages of the McDonald procedure are that it can be performed quite rapidly, with minimal risk for blood loss or infection, and can be more easily removed to permit a vaginal delivery. The disadvantages are that it usually cannot be placed as high on the cervix as a Shirodkar, and many clinicians shy away from adequate placement for fear of damaging the bladder or rectum. Indeed, in my experience, the greatest reasons for failure of McDonald cerclages are threefold: they are not placed highly enough, deeply enough, or tied tightly enough to prevent cervical change and downward displacement of the membranes….

Labels: cerclage, cervical incompetence, cervical insufficiency; premature labor

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Cervical Incompetence and Cerclage - 7 - All Cerclages are Not Created Equally

In today’s post, I was originally going to discuss the surgical and medical approach I have used for many years in management of cervical incompetence, but I thought it would first be best to introduce why I think this will be a worthwhile endeavor…

In February of 2006, Dr. Zarko Alfirevic published an editorial entitled: "Cerclage: We All Know How to Do It but Can’t Agree When to Do It.” (Obstet Gynecol 2006;107:219-20). The editorial was written as a commentary to an article in the same issue by Daskalakis and colleagues (Obstet Gynecol 2006;107:221-26) in which the authors described their success with rescue cerclage placed in women between 18 and 26 weeks in whom significant cervical changes (dilation and bulging of membranes) were detected by transvaginal ultrasound screening. The study was not randomized, comprised a total of 46 women, and simply compared outcomes between the 29 who elected to proceed with cerclage and the 17 who chose simply to be treated with bedrest, tocolysis, and antibiotics (also prescribed to the ‘cerclage group’).

The results of the study were quite impressive. In the cerclage group, the mean prolongation of pregnancy was almost 9 weeks and the mean birth weight was 2101 g. These results contrasted dramatically with the ‘control’ group, mean prolongation of 3 weeks and birth weight of 739 g. Twenty-five of the cerclage pregnancies resulted in live births compared with 7 of 17 in the bedrest group. Other outcomes in cerclage vs controls included: neonatal survival 96% vs 57%; delivery at less than 32 weeks 31% vs 94%; and, adnissions to the neonatal intensive care unit 28% vs 86%. The reduction in overall perinatal mortality from the bedrest group of 76% to the cerclage group of 17% is certainly hard to ignore (and even harder to explain to a patient in the same situation in an objective manner). Furthermore, no significant surgical complications were noted in the group that received a cerclage.

Although the potential flaws of a nonrandomized study with a small cohort of women are correctly pointed out by Dr. Alfirevic in his editorial review, and his compliment regarding the success and low maternal morbidity as “testament to the surgical skills of the team” was warranted, I sense a degree of skepticism throughout his comments. And, while it is true that the published literature does not necessarily support the results, personally, I believe them because of the similar (if not even better) success rates we have experienced throughout the years. Indeed, I now fully believe that the premise of the editorial’s title regarding “Cerclage: We All Know How to Do It…” is what is fundamentally flawed and that is perhaps the major reason such disparate results regarding cerclage pervade the literature.

Although cervical cerclage often can be a relatively simple procedure, to say all cerclages are placed equally well is like saying all physicians have comparable skills because they all happened to finish residencies. The bottom line is it just ain’t so! Like any other surgical procedure, the results depend on the skills and experiences of the surgeon. So, with that as background, in our next post, I really will discuss the technique and rationale for the same we regularly use for cerclage…

Labels: cerclage, cervical incompetence

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Cervical Incompetence and Cerclage - 6 - Evaluation and Decisions in Midtrimester

In the last post, we discussed the approach I have chosen to take regarding cervical incompetence and cerclage under fairly straightforward circumstances. Let’s up the ante in today’s post since I care for far more women under more urgent conditions than I do those with a prior history of cervical incompetence who qualify for an early cerclage prior to cervical changes. I would estimate that at least two-thirds of the 200-odd women in whom I have placed a cerclage in the last 6 years, had this performed between 18 and 26 weeks on an ‘emergent’ or ‘indicated’ basis as the result of significant cervical changes in midtrimester. And, I will say at the outset, management under these circumstances is considerably more controversial than that mentioned in our last post!

However, let me start again with a situation that I consider to be relatively ‘straightforward’ – the patient who presents at 18-22 weeks with little or no cervical length and membranes bulging near, at, or even through the external cervical os. This patient is going to usually deliver imminently and I have selected the range of gestational ages because the baby is previable at this point (although 22 weeks is getting very close to that as a possibility) and the importance of this will become more apparent in a moment.

One does not have a lot of time to make decisions under these circumstances, but the patient needs to be adequately evaluated before a recommendation for therapy can be suggested. The main focus of the evaluation is to try to establish whether or not overt intrauterine infection (chorioamnionitis) is driving the process – and that is sometimes not as easy as one might think – because if it clearly is, then the only therapeutic choice is delivery. When a patient in this situation hits the door, the first steps we take after obtaining vital signs (blood pressure, pulse, temperature) include: a complete blood count with differential; blood type and screen; a catheterized urine analysis and culture; cervical cultures for gonorrhea and Chlamydia (if these can be obtained safely – otherwise they may be deferred); a vaginal slide to look for evidence of bacterial vaginosis; and vaginal fluid to screen for ruptured membranes; an ultrasound to assess fetal size, evidence of anomalies, and Doppler flow studies if indicated; and, oftentimes blood chemistries to include electrolytes and liver function tests.

The patient is then connected to a uterine contraction monitor if that is possible, although one must realize that most patients will have contractions or some degree of uterine irritability once the cervix has gotten to this stage and I have found this to be only a relative contraindication to treatment. If cervical change has been documented by ultrasound, I usually do NOT perform a digital exam on the cervix – saving any further evaluation in that regard until the patient is in the operating room if it appears a cerclage will be attempted.

Although I do not routinely perform an amniocentesis on all patients in this situation, there are many providers who do and so do I in selected cases. When amniocentesis is done, the primary purpose, again, is to look for evidence of overt intrauterine infection (when this is not clearly apparent by physical examination or laboratory studies) as might be reflected by the presence of white blood cells, low amniotic fluid glucose levels, and positive amniotic fluid cultures. We do not routinely screen for inflammatory cytokines in the amniotic fluid at this time.

The next step is to put the pieces of the situation together, have a frank discussion with the patient and her family, and provide options for management. If the patient has a fever (not related to a urinary tract infection), and/or high white blood count and differential suggestive of acute infection, and/or a tender uterus with painful contractions and pain between contractions, and/or a purulent cervicovaginal discharge, the presumptive diagnosis is chorioamnionitis and the only safe option is to allow delivery – indeed, delivery is inevitable regardless of what we might do to intervene. The baby is previable and the mother’s life and future fertility may be at risk. I usually begin broad spectrum antibiotic coverage and, if necessary, recommend augmenting the labor process with oxytocin or misoprostol.

If overt infection is not clearly present, then the patient has basically two options – undergo ‘conservative management’ and wait to see what happens or undergo cerclage. I make several points during the counseling session: if delivery appears imminent and remote from fetal viability, she is told this bluntly (or if some cervical length remains and we honestly cannot predict when delivery might occur, she is also told this); if a cerclage is placed, it may precipitate delivery; if infection develops, regardless of the decision to perform cerclage or not, the "ballgame is over" and delivery will be necessary. While the patient is making her decision, I usually will begin indomethacin 50-100 mg initial dose followed by 25-50 mg every 6 hours and an antibiotic cocktail of a cephalosporin (or ‘penicillin’), azithromycin, and metronidazole administered intravenously. Most patients will opt for cerclage under these circumstances simply because they feel like “what have I got to lose” if the chances for the baby are otherwise hopeless.

The decisions are a little tougher when the baby is in the range of potential viability, especially from 23 weeks on. As in most neonatal intensive care units with high volume services, our neonatal survival rate between 23 and 24 weeks is in the range of 30-50% and it goes up dramatically from that point on, although at the earlier gestational ages, there is also a very high risk of long-term morbidity and mortality secondary to complications of prematurity. Patients at these gestational ages are evaluated and begun on the same treatment regimen I have detailed above with the addition of corticosteroids to accelerate fetal lung maturation. Usually we provide consultation with one of the neonataologists as well.

Under these circumstances, if the membranes are above or at the external cervical os, I still offer cerclage as an option – although the risks are clearly delineated that we could precipitate a delivery as a result of the procedure itself at a time in pregnancy when even days can have a significant impact on potential outcome for the baby. If the membranes have completely prolapsed into the vagina, the success of the procedure is so low with the risk of rupturing membranes during the procedure and the risk of subsequent infection following the procedure so high, that I will usually advise only conservative management with bedrest, antibiotics, corticosteroids, and tocolytic therapy in the hospital until delivery.

Although many years ago, before the dramatic advances in neonatal intensive care, I would perform cerclages if appropriate up to 30 weeks gestation, it is difficult to justify that now – indeed, I have to think long and hard before even offering it as a possibility once a pregnancy has reached 26 weeks. In our next post, I will detail the technique I have used for cerclage placement in these situations for the better part of 20 years…

Labels: cerclage, cervical incompetence, cervical insufficiency; premature labor

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Cervical Incompetence and Cerclage - 5 - Cervical Assessment

Once the suspected diagnosis of cervical incompetence has been established, a decision has to be made regarding what therapy is offered to the patient. I have found that the patient’s participation in that decision is often very important. When discussing options, one must consider the gestational age, the extent of the cervical changes, the risks and benefits of different interventions and noninterventions, indications and relative and absolute contraindications to various treatment options, and the patient’s own risk tolerance. When all is considered, the possible range of ‘therapeutic options’ may include anything from simply following cervical length, to no intervention, to induction/augmentation of labor, conservative ‘medical’ therapy, or cerclage.

In today’s post, let’s put the simplest case behind us first – the patient who appears to have cervical incompetence by past obstetrical history. In most instances, the most sensible option is to simply place a cerclage in early pregnancy usually around 13 weeks. This timing was originally recommended (prior to ultrasound) because most patients who were going to spontaneously miscarry a pregnancy will usually do so by the end of first trimester – including most babies with chromosomal abnormalities – fetal heart tones could be detected to confirm ‘viability’ and, it is exceedingly rare to have any significant cervical change prior to this time that would lead to miscarriage in and of itself.

In recent years, we have another reason that this is a good time to place a cerclage – the opportunity to perform combined first trimester screening for aneuploidy and to obtain a definitive diagnosis by chorionic villus sampling (CVS) if the screening result appears to place the patient ‘at risk’ for a chromosomally abnormal baby prior to placing a cerclage. The patient must be told that this screening test will not detect all chromosomally abnormal babies, and that babies can have other problems not detectable by ultrasound at this time, but it certainly offers significant reassurance.

If the past obstetrical history raises some doubt as to the diagnosis of cervical incompetence, or if the patient simply prefers, the alternative is to serially follow cervical length in the hope of detecting changes that would permit timely placement of a cerclage should the need arise. Under these circumstances, I usually begin cervical assessment by transvaginal ultrasound at about 16 weeks with the interval of testing determined by the findings at a given visit. Incidentally, even after a late first trimester cerclage has been placed, it has been my approach to serially follow these patients by transvaginal ultrasound through midtrimester. The advantage of having the cerclage in place is that it often provides a margin of safety that allows additional intervention to prevent extremely preterm delivery before advanced cervical changes prevent that opportunity.

With regard to the transvaginal ultrasound assessment of the cervix, one of the points I did not discuss in our last post was what constitutes “significant cervical change.” I do not think anyone would argue that membranes bulging at the level of the external cervical os or that a patient with ‘risk factors’ who starts with a 40mm cervix and presents two weeks later with an endocervical length of 10 mm with membranes ballooning to that point in the cervix constitute problems. Nor would anyone argue that the patient who has a very ‘suspicious history’ for cervical incompetence but maintains a cervical length of 40 mm without any loss of integrity at the internal os throughout midtrimester is not likely to be a problem. However, what about the ‘in between’ cases?

In the latter, there are lots of shades of gray and multiple scientific publications dating back 20 years or more to provide some guidance to suggest the diagnosis of cervical incompetence. Personally, I rely on three factors: change from baseline (33% or more decrease), overall length (usually < 26 mm and definitely < 16 mm), and distention of the endocervical canal by membranes (indicating loss of integrity at the internal cervical os). And, it is not at all unusual to have ‘abnormalities’ in all of these parameters in the woman with an incompetent cervix. Although it is controversial, I will frequently ‘challenge’ the integrity of the internal os by exerting slow, steady fundal pressure on the uterus while observing the cervix transvaginally by ultrasound in women in whom I am very suspicious of having cervical incompetence. If by doing so, the internal os opens and membranes then extend into the cervical canal, significantly shortening the cervix, I am much more likely to view this dynamic event as an abnormality consistent with cervical incompetence. On the other hand, if a patient has a cervical length of only 25 mm at 16 weeks, but retains integrity at the internal os and does not shorten with funneling when challenged, I am not at all adverse to simply following that patient over time…

Labels: aneuploidy screening in first trimester, cerclage, cervical incompetence, cervical insufficiency; premature labor, chorionic villus sampling

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Cervical Incomptence and Cerclage - 4 - Diagnosis

As pointed out in our previous posts on this subject, one of the greatest frustrations of cervical incompetence has been to establish its diagnosis in a timely and reliable fashion. Since multiple factors can contribute to cervical incompetence, and the patient’s own response may not be consistent during different pregnancies, cervical incompetence must not be viewed as a ‘disease’, so much as a ‘syndrome’ with a common final pathway. And, being a ‘syndrome’ in this case makes it easier to understand why there is not a ‘diagnostic test’ for cervical incompetence – indeed all we really have are several different methods of screening for the condition.

I divide screening into several different categories. The first is the patient’s obstetrical history – the classic approach upon which we relied during my training. If the patient presents for consultation with a history of premature delivery or midtrimester pregnancy loss, it is important to characterize the events surrounding the delivery in as much detail as possible from both the patient’s recollections and the medical records. For example, some of the questions asked include: gestational age at delivery; presence or absence of painful contractions prior to presentation and the duration of the same; cervical status at presentation (long, short, firm, soft, degree of effacement); amount of amniotic fluid (too little, too much); condition of the membranes (intact, ruptured, or ballooning in the vagina); evidence of prior or concurrent urinary tract infection, sexually transmitted infection or bacterial vaginosis; other pregnancy-related or previous medical conditions (including history of infertility and known Mullerian anomalies) and type of medical therapy; size of the baby and appropriateness for gestational age; course of the labor itself (short, long, use of oxytocin and why); outcome of the baby and neonatal complications if the baby was not stillborn; pathologic evaluation of the placenta and baby; laboratory studies obtained at the time of admission (e.g., CBC, urinalysis and culture); and, if this was not a first pregnancy, comparison of this pregnancy to the others with regard to these factors and intervening procedures (e.g., traumatic vaginal delivery, D&C, cervical conization, myomectomy). The goal of this line of questioning is to try to separate the possible diagnosis of cervical incompetence from other causes that may or may not put another pregnancy at risk for premature delivery. The patient with cervical incompetence is much more likely to have a history of relatively painless labor, presenting with advanced cervical dilation and effacement (out of proportion to the labor), followed by a rapid delivery. If she has had previous pregnancies, there is also a tendency for sequentially earlier deliveries with cervical incompetence.

The problem with the ‘historical approach’ to screening is that it often meant a patient lost one or more pregnancies before a ‘diagnosis’ of cervical incompetence was established and if the pertinent historical information could not be accurately obtained, the diagnosis might be further delayed. To address that concern, over the years, I have put together my own little laundry list, based on both experience and, where available, the scientific literature, of women who should be observed more carefully, even during a first pregnancy, for evidence of cervical incompetence. Included among those risk factors are those mentioned in our last post: family history of premature delivery and cervical incompetence; maternal obesity; congenital uterine abnormalities; uterine fibroids; previous uterine surgery (e.g., D&C, removal of uterine septum, myomectomy); previous cervical surgery; history of maternal infertility and assisted reproductive techniques for conception; multiple gestation; recurrent vaginal and urinary tract infections; connective tissue disorders (e.g., Ehlers-Danlos syndrome and Marfan’s syndrome) and perhaps collagen vascular diseases; polycystic ovary syndrome/insulin resistance; and perhaps diabetes. In addition to predisposing risk factors, one should remain alert to those that develop during pregnancy and also maintain a high index of suspicion related to certain patient complaints such as increasing pelvic pressure or excessive vaginal discharge, both of which may accompany premature cervical effacement.

The major contributor today to cervical evaluation in both categories above, and the primary means of detecting cervical incompetence in the presence of new ‘signs and symptoms’ or, fortuitously, during other assessment, has been ultrasound. I am not going to make any effort to review the literature that debates the value of ultrasound in this regard. In the most general sense, cervical length in midtrimester is inversely proportion to the risk for preterm delivery; and in women at greatest risk for preterm delivery, the course of their cervical changes and the events surrounding delivery often are consistent with the traditional history we attribute to cervical incompetence.

However, evaluation of the cervix involves more than simply measuring the length (or what’s left of the length) of the endocervical canal. Other factors to consider are the changes in length over time, the configuration of the internal os and the endocervical canal, and the presence of and degree of distention by membranes in the endocervical canal. In the patient who is being followed for possible cervical incompetence by history, or who has risk factors for the same, serial evaluation may be necessary and, in my practice, preferable. Most women with cervical incompetence will develop visible changes in the configuration and length of the endocervical canal between 16 and 24 weeks. And, with serial follow-up, one is more likely to detect changes at a time when intervention can still provide a favorable outcome for the pregnancy.

One of the questions that has been raised is whether or not ALL pregnant women should be routinely assessed for cervical incompetence in midtrimester. I can tell you that over the past 6 years in my own experience, at least one-third of the cases of cervical incompetence necessitating placement of ‘rescue’ cerclages have been in women between 18-24 weeks with no previously recognized risk factors in whom advanced cervical changes were detected during the course of a routine sonogram to assess fetal growth and anatomy usually scheduled for that time in pregnancy.

In most cases, a ‘suspicious’ cervix was first noted during transabdominal assessment and then confirmed transvaginally. When one considers the safety of ultrasound and the speed with which a transvaginal sonogram can be performed, the epidemic of obesity (a risk factor itself) that precludes adequate transabdominal assessment of the cervix, and the potential savings to the healthcare system by preventing the delivery of even a few 23-26 week babies annually at any institution, I think the cost of including cervical assessment during the routine pregnancy ultrasound examination that has become standard at 18-22 weeks, the additional cost of the transvaginal ultrasound could be readily justified…

Labels: cerclage, cervical incompetence

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Cervical Incompetence and Cerclage - 3 - Significance of the Internal Cervical Os

The incidence of cervical incompetence in the general population is really not known and probably varies by population subgroups. Estimates range between 1 in 100 and 1 in 2000. My sense over the years (considering the number of cerclages I have placed in midtrimester) is that it is more common than widely recognized and that the higher estimate is probably more accurate (We have almost 6000 deliveries per year at our institution and there is not a week that goes by when I do not place at least one ‘rescue cerclage’ in midtrimester). It is also my sense that the incidence appears to be increasing – at least in the populations of pregnant women with which I work on a regular basis. As mentioned in my last post, there are probably innate, acquired, and iatrogenic factors that contribute to the ‘syndrome’ of cervical incompetence. And, many of these factors overlap with those that are commonly recognized as risk factors for premature labor and delivery.

Some of the potential risk factors for cervical incompetence include past obstetrical and family history of premature delivery and cervical incompetence, maternal obesity, congenital uterine abnormalities, uterine fibroids, previous uterine surgery (e.g., D&C, removal of uterine septum, myomectomy), previous cervical surgery, multiple gestation, traumatic vaginal delivery, recurrent vaginal infections, connective tissue disorders (e.g., Ehlers-Danlos syndrome and Marfan's syndrome), polycystic ovary syndrome/insulin resistance, and perhaps diabetes. There is debate that a ‘short cervix’ by itself may increase the risk for cervical insufficiency, but if the cervical connective tissue is normal and there is no loss of integrity at the internal cervical os, this seems to be a weak call in many instances.

Whether there is an underlying connective tissue abnormality of the cervix, pathologic activation of the cascade of biochemical events that leads to remodeling of the cervical connective tissue, or simply a congenital or acquired anatomical abnormality of the internal cervical os, the most pathognmonic and sentinel event occurring with cervical incompetence is progressive loss of integrity at the internal cervical os. Cervical change that anticipates labor starts from the inside and progresses outward. Premature cervical ‘remodeling’ can lead to this loss of integrity at the internal os, but it is also often seen in conjunction with congenital uterine malformations (Mullerian defects) that affect midline structures (such as the cervix) and as the consequence of trauma during operative procedures, the most common being D&C. I emphasize this point, because I am a firm believer in the laws of physics with regard to cervical incompetence and its progression, even prior to the connective tissue remodeling (‘ripening’) that will eventually occur once the cervix has been stretched from within.

Let me elaborate on this in the way I explain it to patients: The internal cervical os is supposed to remain closed and basically contiguous with the rest of the inner surface of the uterus – distributing the weight of the baby and fluid over that entire surface area. If the internal os has been damaged and is not closed, or if other factors decrease the resistance at that anatomic site allowing it to begin to open, the tendency will be to simply continue to open, and as that progresses, it actually takes less pressure to continue that process with time. We are talking simple physics here, the same principle that holds when we drive a wedge into a log to split it. It’s hard to get started and then eventually it just gives way.

All women who wear spiked heels should know the reason for this. If you concentrate all the weight of your body, say 150 lbs, on a heel that measures say .2 x .2 inches that translates into a weight of 3750 lbs per square inch! That’s why spiked heels can punch holes in flooring. If we apply that same thinking to pregnancy and the entire volume of the uterus is focused on a weak point, a defective and slightly opened internal cervical os, the tendency is to enlarge that opening and eventually squeeze the membranes into the cervical canal – an event we call cervical funneling – just like squeezing a water balloon through a small opening. The important thing to recognize is that we CAN detect loss of integrity at the internal os during pregnancy by ultrasound and evaluate the configuration of the cervical canal as it begins to distend with membranes and amniotic fluid BEFORE this is readily apparent by clinical symptoms or obvious changes evaluable by vaginal examination of the patient. And this sometimes gives us an opportunity to intervene in a way that can prolong and preserve a pregnancy that might have otherwise been lost or accompanied by extreme prematurity and its attendant morbidity....

Labels: cerclage, cervical incompetence

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Cervical Incompetence and Cerclage - 1 - An Introduction

I have had several readers request information about cervical incompetence and cerclage. These are interrelated subjects in which I have had a keen interest and much personal experience over the years, but they have also been the topics of considerable controversy in our professional literature. And, except for some brief references to these in previous posts, I have chosen until now to avoid a more detailed discussion. The reasons for that are not so much apprehension about facing my peers (since this is not a peer review journal and I would put my experiences and successes up against anyone’s), as an uncertainty as to how to address the subject in a way that would be informative and relevant to a wide range readers as well as objective in its presentation.

Cervical incompetence, or cervical insufficiency, relates to premature, progressive cervical change that subsequently results in preterm delivery and/or pregnancy loss. Most purists will also add the admonition that such change must occur in the absence of uterine activity (i.e., painless cervical dilation and effacement) – a point that was emphasized in my own training and with which I now take major issue. The problems with the study of cervical incompetence are that, like preterm labor, the underlying causes and pathology can be multifactorial, the diagnostic criteria are not consistent, and treatment regimens, including the value and timing of cervical cerclage, are varied and difficult to subject to critical, randomized research because of the vastly different experiences and skill sets of physicians and the sensitive issues related to what is in the balance, specifically, the life of the baby, under circumstances when patient and provider have their backs against the wall and the pervasive attitude is often: “Well, what have we got to lose by trying?” “If we don’t do something, the baby will be lost anyway or delivered so early that he/she is at great risk for mortality or life-long morbidity secondary to prematurity.”

In recent years, the debates on all fronts have come to the fore. The primary reason for this is that prior to the widespread application of ultrasound to the evaluation of the cervix in midtrimester, the diagnosis of cervical incompetence was usually a retrospective one – made only after the preterm delivery and/or loss of one or more babies under circumstances that met the “definition” of cervical incompetence. And, believe me, when the purists got involved and the strict criteria were applied, the debate was often quite heated – “She had some contractions with that pregnancy, so it must have been preterm labor and not cervical incompetence.” “She came in with a fever, so it must have been chorioamnionitis (infection of the membranes) and could not have been cervical incompetence.” “She delivered her last baby at 35 weeks, so how could she have an incompetent cervix.” Anyway, you get the picture. The problem with all these sorts of comments is that they tend to ignore the possibility of “What came first, the chicken or the egg!”

However, now we have a lot of experience with evaluation of the cervix by ultrasound, and some of us have a very low threshold for performing the same under circumstances wherein the patient may be ‘at risk’ for cervical incompetence or when there appears to be premature cervical changes picked up as an incidental finding at the time of a routine ultrasound done at 18-20 weeks for the assessment of fetal anatomy. And, as a result, and as I will detail in subsequent posts, we are now in the position of more often detecting what may be either significant (advanced) premature cervical changes that permit late (“rescue”), but timely, intervention with even a first pregnancy as well as more subtle changes that may or may not indicate the patient is truly at risk for preterm delivery or pregnancy loss. It is the latter group that currently should be approachable by randomized research to clarify the most sensible approach to therapy, but even that is proving more difficult with time.

In this series, I will have several goals: We will provide a basic understanding of cervical structure and illustrate the differences between the cervix and the uterus; we will briefly discuss the biochemical changes that occur in the cervix coincident with cervical change and the factors that might contribute to those events prematurely; we will point out risk factors for cervical incompetence; we will discuss assessment of the cervix by ultrasound; and we will discuss treatment options under various conditions, including my own approach to cerclage – focusing on that approach under pregnancy “rescue” conditions…so, stay tuned!

Labels: cerclage, cervical insufficiency; premature labor, incompetent cervix

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Midtrimester Loss: Preterm Labor vs. Cervical Incompetence

Below is a sequence of comments between a reader and me related to the unending difficulties we encounter sorting out the cause of midtrimester pregnancy losses: Is it preterm labor, cervical incompetence, uterine infection, fetal chromosomal abnormality (or some other problem) or a combination of more than one factor? When I trained, I was taught that “if the patient is having contractions, it is preterm labor and not cervical incompetence and a cervical cerclage (stitch around the cervix) was NOT indicated” and many physicians still believe that. But over the years, I have learned that things are not always that simple!

Thanks to the many desperate patients I have had with advanced cervical change in midtrimester (generally, at 24 weeks or less), no evidence of overt infection, but some uterine contractions, who begged me to “do something because we have nothing to lose by trying at this point”, I quickly learned that many of these patients could have their pregnancies salvaged by using broad-spectrum antibiotics, a ‘rescue’ cervical cerclage, and suppressing the uterine contractions. In many (actually, most in my experience) of the cases, the pregnancies carried until there was a good outcome for both baby and mother. The only thing I asked these patients to agree with me on up front was that I would have to end the pregnancy, regardless of gestational age, if there was evidence of intrauterine infection. At that point, the mother’s life is at risk and there is no further benefit to the baby to remain in the uterus.

The series of comments below help you to understand the physician’s thought processes and, to some extent, the patient’s misconceptions, that occur around the always traumatic experience of losing babies in midtrimester. (I apologize to the reader because I have edited some of her comments).

• At Wed Feb 06, 06:57:00 AM 2008, Anonymous said…

Dear Dr T,
After my last miscarriage, my doctor evaluated me for the possibility of a thrombophilia problem but found nothing. Me and my partner have also had our chromosomes examined and both of us were normal. The upshot was that no causes for the miscarriages were found. This leaves me with a lot of questions. Why did I have twice very late miscarriages? Currently I am pregnant again, but I am very afraid that it will happen again. I fear that there is something wrong with me which have caused the miscarriages. How likely is this if I already have had a full term delivery? Could my second miscarriage have been caused by the progesterone injections I was given because of my first loss? Would you advise me to take progesterone injections in this pregnancy (my doctor does). Does progesterone have any adverse effects on pregnancies? I would be very grateful if you would like to answer these questions or advise me further on this.
Kind regards

• At Sun Feb 10, 07:02:00 PM 2008, Kenneth F. Trofatter, Jr., MD, PhD said…

To Anonymous Feb 6: Answer several questions for me and then I will be in a better position to respond to yours:

1) Did you have the full-term pregnancy and then have the miscarriages?
2) Did you have any complications with the full-term pregnancy or with the delivery?
3) Did you have a vaginal delivery or a cesarean?
4) Have you had any cervical operations such as LEEP or cervical conization done?
5) How "late" were the miscarriages you had?
6) What were the circumstances surrounding those miscarriages, i.e., did the babies die in utero; did you have premature labor; did you break your bag of waters prematurely; did you have any evidence of 'infection'; did you labor or did your doctors put you into labor; did you receive progesterone with either of those losses; and, do you have any medical problems?

There are reasons for ALL of these questions and the answers will help me get a better idea as to what happened with your previous losses. Dr T

• At Wed Feb 13, 05:17:00 AM 2008, Anonymous said…

Here are my answers:

1) Yes, I had a full-term pregnancy first and had the two miscarriages thereafter.

2) The full-term delivery took very, very long (almost 40 hours from the first signs) and eventually I was given medicine to deliver my daughter. I could not have done it by myself probably. I had heavy bleeding afterwards (post-partum hemorrhage) and was very weak for more than two weeks following the delivery.

3) It was a vaginal delivery.

4) I don’t know what these (LEEP and cervical conization) are, but before having my daughter and the miscarriage, I had two abortions (I was too young then). And after the first late miscarriage the doctor cleaned up my uterus (did a D&C) as the pregnancy product did not leave my uterus completely (retained placenta).

5) The first time the baby was 20 weeks and a couple days old, he was born alive and I had premature labor. After this miscarriage the doctor thought (although I didn't have any infections) that the miscarriage might have been caused by a bacteria (slight increase of granulocytes in my blood) or cervical incompetence. However, he was not sure. I also then had a severe allergic reaction to the antibiotic I was given in the hospital in order to prevent any infections. My blood pressure was 80/40 and I was in very bad condition. So maybe this might also have caused the increase of the granulocytes or even the eventual delivery as I did not have a lot of dilation at first, but the situation got worse after I got the antibiotics.

The second time I delivered at 19 weeks; the baby probably had died at 15/16 weeks. I had no labor at all and was given medicine to deliver. Only in this pregnancy I was given progesterone (starting at week 16 because of the first miscarriage and in order to prevent any cervical incompetence. Again this time there were no signs of infections, and to my knowledge I am healthy and do not have medical problems. My age is 35.

In both cases I did not have break of bags/water.

So this leaves me with questions: Why does this happen so late and do I have to live with the knowledge that this kind of thing happens without reasons? And, could the second miscarriage have been caused by the progesterone as the period the baby died was more or less the period I started with the injections? Would you advise me to take these injections also in this pregnancy?

Would you advise me to take extra vitamins, other than folic acid (as I have been pregnant many times in a relatively short period)? Could this circumstance have played a role (short period in between pregnancies) in my losses? I would be grateful for your answers.

• At Fri Feb 22, 07:06:00 PM 2008, Kenneth F. Trofatter, Jr., MD, PhD said…
To Anonymous Feb 13: I do not think the abortions you had when you were younger contributed in any way to your more recent losses. However, I am worried that the first full-term delivery might have. You could have had damage to your cervix from the difficult labor and delivery or from the D&C procedure that had to be done to stop your hemorrhage.

I believe your first loss at 20 weeks, was the result of cervical incompetence and probably a secondary ascending infection. Once the cervix started to change, the contents (baby, membranes, and placenta) are more readily exposed to the bacteria within the vagina. I am not sure you really had an 'allergic reaction’ to the antibiotics. The low blood pressure and being in “very bad condition” is more consistent with 'septic shock’ resulting from a bacterial infection that had gotten into your blood stream from your uterus. I also do not think either the antibiotics or your 'bad reaction' caused you to lose that baby, it may well have just seemed that way because everything was getting worse after the antibiotics were given, but it was probably too late for them to be of any benefit. Significant infections in the womb will usually cause delivery within 48-72 hours regardless of any antibiotics that could be given to you.

Your loss at 15-16 weeks might also be the result of infection, or perhaps the baby had a chromosomal abnormality and that’s why he/she died. It is VERY unlikely the progesterone alone caused you to lose that baby. Indeed, the baby could have died even before you got the first shot based on the timing you have given to us. However, some people believe that progesterone can possibly reduce your body's ability to fight off some infections (although that has NOT yet been proven), so I will not rule out that possibility completely.

Before you get pregnant again, I would recommend that you have a sonohysterogram and perhaps a hysteroscopy done to evaluate the uterine cavity for any abnormalities that could be present (e.g., fibroids, polyps, scar tissue, and endometriosis). Your doctor might also consider treating both you and your husband with a 10-14 day course of an antibiotic such as doxycycline. I would suggest starting a prenatal vitamin and extra folic acid a month or two before you decide to try again and then, when you do get pregnant, personally, I would recommend placement of a cerclage at 13-14 weeks. I also recommend that before that is done (at 11-12 weeks), you have first trimester screening for aneuploidy (fetal chromosomal abnormality) performed. This involves only a simple ultrasound of the baby and some blood work on you. Your doctors can explain all of these procedures and the reasons for having them done. Incidentally, I would probably also offer you the progesterone injections again, serially follow your cervix by ultrasound starting at 15-16 weeks,and periodically evaluate you for evidence of asymptomatic urinary tract and vaginal infections until you got past 28 weeks.

Best of luck to you and please let us know what is found, what you do, and how things turn out!
Dr T

Labels: 17-hydroxyprogesterone caproate, cerclage, cervical incompetence, midtrimester pregnancy loss, preterm labor

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"A Stitch in Time..."

Today, let’s take a break from my ‘lecture series’ on preterm birth and present a real-life patient who illustrates a scenario in which experience, technology, and timely intervention averted a tragic pregnancy outcome from PTB…

Recently, we helped care for a woman carrying twins conceived by in vitro fertilization. She had a long history of infertility associated with polycystic ovary syndrome (PCOS) and at age 38 had all but given up hope of ever carrying a pregnancy. Our infertility group, and her primary obstetrician, had sent her to us for consultation at 12 weeks’ because of her age and the multiple gestation. She had no other significant medical problems and the discussion was very straightforward. We talked about PCOS-associated risks of hypertensive disorders and gestational diabetes and we also talked about the age-related risks of fetal chromosomal abnormalities and her options for prenatal diagnosis. She was well-educated and there was little new information I could provide her with on these topics.

We then talked about fetal complications specific to twin pregnancies and finally we got around to the subject of preterm labor. In brief, I informed her that she was at greater risk for PTB, not only because of the twins, and this being her first pregnancy, but also because of her underlying PCOS for reasons that are poorly understood and unrelated to any other medical complications either she or the twins might develop during the pregnancy. My specific concern was related to a condition called “cervical incompetence” that seems to haunt infertility patients with PCOS. Of all the things we discussed, this worried her the most. After all the time (and money) it had taken to conceive, the last thing she wanted was “to deliver too early and at my age have children who have problems resulting from prematurity.” When she left that day, I scheduled her to return at about 20 weeks’ for ultrasound evaluation of the babies and her cervix.

Cervical incompetence represents loss of integrity at the internal cervical os (the junction of the cervix and the uterus) that results in progressive cervical change from the inside out. Lots of factors can contribute to cervical incompetence and we will save that discussion for another day. Before the availability of ultrasound, however, the diagnosis was almost never made before a woman had delivered prematurely, or lost one or more pregnancies, with a history of 'silent' cervical dilation, usually presenting in the advanced stages of labor, preceded by minimal painful contractions. Over the last 10 years, we have learned that ultrasound evaluation of cervical length and configuration can help to identify cervical incompetence and certain women at increased risk for premature delivery.

When our patient came back at 20 weeks,’ her baby girl and boy looked fine. Her cervix measured 42 mm in length (very good!) but “slight funneling is noted at the internal cervical os.” No cause for immediate concern or action, but with that finding, she did buy herself a follow up ultrasound. Although scheduled for the next week, she could not keep that appointment. When she did return two weeks later, she now had “U-shaped funneling of membranes in the cervical canal to within 3 mm of the external cervical os” (very BAD!). To make a long story short, she was admitted to the hospital that day and underwent placement of an emergency (“rescue”) cervical cerclage (stitch around the cervix). At the time of the surgery, “the cervix was 1-2 cm dilated and membranes were clearly visible just within the cervix.” If something had not been done at that point, she surely would have delivered extremely prematurely, probably within days. Although the surgery went well, she understood that she still wasn’t out of the woods for early delivery and complications, especially those related to infection.

There is a happy ending to this story. She eventually carried the babies to 36 weeks’ before spontaneously rupturing membranes, having the cerclage removed, and delivering two beautiful healthy children who got to leave the hospital with her two days later. Technically, she had two “near term” births, but that was so much better than losing two babies at 22 weeks or, perhaps even worse, having two babies survive at 23-24 weeks with severe sequelae secondary to their prematurity. Like I said before, in the case of PTB, every little bit helps. Multiple factors contribute to PTB, but the key to reducing rates is to successfully anticipate risks and identify specific factors in individuals that might lend themselves to timely intervention.

Labels: cerclage, cervical incompetence

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