TREATMENT FOR CERVICAL INSUFFICIENCY AT

DESERT WOMEN’S CARE

DWC has extensive experience in treating women with pregnancy loss or pre-term delivery associated with incompetent cervix. Desert Women’s care is one of a handful of providers capable of treating women with abdominal cerclage, placed through the laparoscope prior to initiation of the pregnancy or up to about 20 weeks gestational age. 

Benefits of Cervical Cerclage in women with singleton pregnancy and prior preterm delivery or new diagnosis of cervical insufficiency is presented here.

Two different conditions account for early delivery: preterm labor and cervical insufficiency.  Preterm labor involves painful uterine activity intensifying and culminating in delivery.  Cervical insufficiency often involves painless uterine activity.  Although not invariably, preterm labor often occurs later in subsequent pregnancies while delivery from cervical insufficiency commonly occurs earlier.  A short cervix noted in the mid-trimester ultrasound is common to both conditions. 

Cervical insufficiency results from both congenital and acquired factors.  Congenital factors include collagen abnormalities, structural uterine abnormalities, DES exposure by the patient’s mother and normal biological variation.  Ehlers-Danlos syndrome, for example, can impact type 1 collagen and may account for familial clusters of cervical insufficiency. [1]  Various types of uterine malformations have been long been associated with pregnancy failure, from miscarriage to prematurity. [2]  Maternal DES exposure as an etiology of cervical insufficiency has been epidemiologically corroborated but will soon become a historical footnote. [3]

Cervical insufficiency can also be acquired as a result of obstetric trauma, mechanical dilation and excisional cervical biopsies.  Cervical laceration is known to weaken the cervix just as tearing at the time of cervical dilation for termination or gynecologic surgery. [4-6]   LEEP or cervical cone biopsy are also associated with cervical compromise and predispose to insufficiency.

Premature onset of labor is the other condition.  This may come with or without preterm, premature rupture of membranes.  In instances without suspected intra-amniotic infection and without active uterine activity, medical management has been shown to decrease the likelihood of premature delivery in women with prior preterm delivery. 

A short cervix on mid-trimester ultrasound can be common to both cervical insufficiency and premature labor.

Predictability of Early Delivery

Mid trimester cervical length measurement can help determine how likely a woman is to have a premature delivery in the current pregnancy.

Berghella, et al, [7] demonstrated that in women with prior preterm labor and short cervix demonstrated on mid-trimester ultrasound, cerclage was associated with a reduced prevalence of preterm births  in the current pregnancy. Short cervix was defined as cervical length < 2.5 cm (hazard ratio 0.66; 95% confidence interval, 0.45 – 0.92).

Additional data is available from the Vaginal Ultrasound Cerclage Trial. [8]    A total of 831 women with prior preterm delivery less than 35 weeks were enrolled in the study. Of those women, 318 were found to have cervical length < 2.5 cm at 20 weeks. A total of 302 of these women were randomized to cerclage vs. no cerclage groups. This study found no statistically significant difference between these two groups.  Subset analysis was performed, however, in women with cervical length less than 1.5 cm at twenty weeks.  In this group a clear, statistical benefit in terms of reducing preterm delivery in the current pregnancy was noted for the cerclage group.

A 2010 Review article in AJOG by J. Iams and V. Berghella [9]  suggests use of < 2.5 cm as the cut-off point for offering cerclage to women with one or two prior preterm birth in the 16 – 23 week window. The same article suggests women with three or more prior preterm births should be offered cerclage in the 12 – 14 week period. Furthermore, women with prior preterm birth < 33 weeks with cerclage on board may benefit from a trans-abdominal Cerclage in the following pregnancy.

Current Desert Women’s Care Management--
 
Prior preterm Delivery less than 36 weeks and normal cervical length:

DWC typically starts 17-Hydroxy Progesterone injections between 16 and twenty weeks gestational age in these women. [10-13]  Anti-Phospholipid Antibodies and Anti-Thyroid Antibodies are drawn on a case by case basis.  Many of these women are started on Home Nursing and Telephone Support and are questioned regularly on symptoms of preterm labor.  Hospital-based tocolytic therapy is administered on an as-warranted basis along with steroid when delivery is suspected to enhance pulmonary maturation.  DWC also believes in the neuro-protective benefits of Magnesium Sulfate and uses it when delivery less than 32 weeks is anticipated.

Prior preterm delivery and short cervix at mid-trimester ultrasound:

In women with a cervical length < 2.5 cm on the mid-trimester ultrasound examination, in addition to the above guidelines, a cervical cerclage is discussed with the patient and performed, if elected by the patient after review of risks and benefits, as soon as possible. Vaginal examination for length of portio vaginalis (amount of cervix accessible through the vagina) and number of prior preterm births determines whether vaginal or abdominal cerclage is recommended.

Prior mid-trimester loss:

In women with prior mid-trimester loss and likelihood of cervical insufficiency, Cerclage is offered.  Most experts believe the first Cerclage following a loss from cervical insufficiency should be placed vaginally.  Only if a vaginally placed Cerclage is not technically feasible should a trans-abdominal Cerclage be performed. 

In women with diagnosis of cervical insufficiency and a prior mid-trimester loss with a vaginally-placed Cerclage, trans-abdominal cerclage is indicated. 

Cerclage Risks

A recent study by Keeler [14]  shows a 0.6% likelihood of peri-operative complications resulting from cerclage indicated either based on history or cervical length ultrasound findings.  It is worthwhile to note that average gestational age at placement was 13 weeks for the history-indicated group and 19 weeks for the ultrasound-indicated group.  The chance of pre-viable delivery in this population was 5.9%, preterm delivery was 20% and chance of term delivery was 73%.

Transvaginal Cerclage

General consensus favors transvaginal cerclage as the first choice cerclage option.  Typically Cerclage is reserved for women with a prior preterm birth and short cervix in the current pregnancy.  Clear history indicating cervical insufficiency is another indication.  “Rescue” cerclage is offered to women with painless advanced cervical dilatation in the current pregnancy.

A McDonald [15] or Shirodkar [16] cerclage are the two principal surgical procedures.  The goal is to place the mersilene band or suture as close to the internal os as possible.  The Shirodkar procedure by design places the suture closest to the internal os, however, the extra dissection makes the procedure technically more difficult and predisposes to more bleeding and general morbidity.

Cerclage can be performed either with regional or general anesthetic. [17]  Transvaginal ultrasound can be of benefit in locating the internal os and meternal bladder intra-operatively. [18] 

Various studies have failed to demonstrate an advantage of either McDonald or Shirdkar over the other. [19-21]  Most studies on success of cerclage use the patient as her own control.  Harger published a viable birth rate of 70 – 90% in the cerclage pregnancy compared with 10 to 30% in the pregnancy prior to placement of cerclage. [21]   Two randomized studies observed better outcomes even in untreated women (expectant management vs. cerclage with history of cervical insufficiency in prior pregnancy) in the subsequent pregnancy. [22-23]

Abbyloopers reports on 281 cases of women with incompetent cervix and prior preterm delivery or second trimester loss undergoing trans-abdominal cerclage (TAC, placed via either laparotomy or laparoscopy). [24]

With abdominal cerclage a significant number of these women had term birth with very few delivering non-viable fetuses. Complicatins of TAC are diagrammed.

Various studies have addressed abdominal cerclage dating back to 1965 (see Appendix, below).

Zaveri [25]  in 2002 looked at women whose prior pregnancy ended in a mid-trimester loss or a preterm birth prior to 34 weeks.  Abdominal cerclage lead to a lower likelihood of delivery prior to 24 weeks and perinatal death compared with women undergoing a repeat vaginal cerclage—6 vs. 12.5%.

Lotgering [26] in 2006 published a series of open abdominal cervical-isthmic cerclages performed on 101 women with classic history of cervical insufficiency. In prior pregnancies 93 had vaginal cerclage, 76% of births occurred before 32 weeks and only 27% of their neonates survived.  After the abdominal cerclage only 7% of births occurred before 32 weeks and neonatal survival was 93.5%.   

Debbs [27] in 2007 reported on seventy-five women treated with abdominal cerclage after negative evaluation for recurrent pregnancy loss and one or more previous unsuccessful transvaginal cerclage procedures. The median gestational age at the time of cerclage placement was 13 weeks, and the median gestational age at delivery was 36 weeks. Seventy-two women delivered after 24 weeks of gestation. The fetal-salvage after transabdominal cerclage was 96% in this study.

Whittle [28] in 2009 published results of laparoscopic abdominal cerclage.  Of  65 patients undergoing cerclage (31 pre-pregnancy and 34 during pregnancy at  average gestational age of 13 weeks),   fetal salvage rate was 89% with mean gestational age at delivery of 35+ weeks.  Fifty-eight percent of patients in this group had a prior, failed vaginal cerclage.

Finally, in 2011 Burger [29] performed a meta-analysis involving 31 studies.    In these studies delivery of a viable infant of at least 34 weeks gestational age was 78.5% in the laparoscopic group and 84.8% in the laparotomic group. No statistical difference was identified.  Second trimester loss rate was 8.1% in laparoscopic and 7.8% in laparotomic patients. 

Because there is no discernible difference between outcomes of the two procedures, we recommend the laparoscopic approach because it is far better tolerated; quicker recovery, less post-operative pain and better cosmesis are the key advantages of minimally invasive surgery.

Timing of Surgery

Desert Women’s Care is technically capable of performing laparoscopic cervical cerclage and, depending on the patient and her circumstances, will do so up until 18 – 20 weeks.  In 2010 Desert Women’s Care was presented with the second place video award at the Society of Laparoendoscopic Surgeons (SLS) Annual Meeting in 2010 for our video on this subject.  Women with short cervix detected at mid-trimester ultrasound should be evaluated for immediate placement.

Women with poor reproductive history, particularly those with prior failed vaginal cerclage, should have consultation prior to initiation of pregnancy or as soon after pregnancy is detected as possible.   Placement of laparoscopic cervico-isthmic cerclage can be done prior to pregnancy.  If pregnancy is established, it is our belief that placement should be delayed to 11 – 14 weeks.

Potential Negatives of Abdominal Cerclage

Women with abdominal cerclage most often require a second procedure at the time of late miscarriage or delivery. 

First Trimester Loss—

Importantly, abdominal cerclage does not seal the cervical canal. Between pregnancies women continue to menstrate.  Because the canal is somewhat open, early pregnancy loss can often be expelled (medical management) or aspirated (surgical evacuation) without removing the cerclage. 

Loss above 12 – 14 weeks often requires laparoscopy to remove the cerclage along with dilation and curettage to evacuate the uterus.  Repeat cerclage placement should be done at a subsequent operation to allow involution of the uterus post operatively.

Viable Pregnancy—

At the time of rupture of membranes or onset of regular uterine activity it is crucial for the patient to notify her care giver.  Unlike vaginal cerclage which can easily be removed to accommodate vaginal delivery, abdominal cerclage patients require Cesarean Section.  Ignored labor can result in significant cervical laceration of even uterine rupture so prompt attention is recommended. 

Our recommendation is to leave the cerclage in place at the time of Cesarean delivery, particularly if future child bearing is desired.  There is no need to remove the mersilene band.  

Abdominal cerclage has a higher likelihood of significant complications, particularly when performed during pregnancy.  Furthermore, the more advanced the pregnancy, the more vascular the uterus becomes and the higher the chance for significant bleeding becomes.  This risk is often balanced by the fact that abdominal cerclage later in pregnancy is usually undertaken on an “emergency” basis in women with prior failed vaginal cerclage with a short cervix. 

CASE REPORT: RESCUE CERCLAGE AT 20 WEEKS--

This patient presented at 20 weeks pregnant having lost her first pregnancy at 24 weeks.  Decision for a “rescue cerclage” was made between the patient’s Obstetrician and Maternal – Fetal Medicine specialist.  Dr. Demir was contacted.

This transvaginal ultrasound image shows funneling and marked shortening of the cervix.  Because there was insufficient cervical tissue noted in the vagina for a meaningful cerclage to be placed decision for transabdominal procedure was reached.  This photo shows the enlarged, pregnant uterus through the laparoscope.

This next series shows opening of the bladder flap and reducing it on the pubo-cervical-vesical fascia.  A Mersilene band is placed around the cervix by puncturing the broad ligament above the level of the uterine arteries at the cervico-isthmic junction.  The final image shows the first loop of the merselene band placed with intra-corporeal tying to secure it around the cervix.

Ultrasound shows the cervix closed and funneling resolved with placement and securing of the Mersilene band.  An intra-operative photo shows the tied knot securely in place.

The finished procedure looks like this:

Because of this procedure a live born baby was delivered via C-Section at term.  DWC is proud to be able to offer this procedure to patients meeting entrance criteria.

Although conventional, trans-vaginal cerclage requires bedrest during a pregnancy, patients enjoy a higher level of activity with abdominal cerclage.  Abdominal cerclage is placed once and all babies are delivered via Cesarean Section.  Patients with trans-vaginal cerclage require a repeat procedure with every pregnancy.

We have been responsible for numerous live born babies from women with incompetent cervix in the last few years.

Our video, “Laparoscopic Cervical Cerclage in an 18-weeks Pregnant Uterus” can be viewed on the "Elite Laparoscopic" channel of YouTube.com or on the SLS channel.

This video won the Honorable Mention (Second Place) Video Award at the Society of Laparoendoscopic Surgeons 2010 Annual Meeting in New York City. Dr. Demir is pictured below accepting the Award.

To view the Fox10 Phoenix story on a Tampa, Florida, couple who traveled to the Valley for an emergency Laparoscopic Cervical Cerclage, click the image, below:

References

1. Larsson LG, Baum J, Mudholkar GS, Srivastava DK. Hypermobility: prevalence and features in a Swedish population. Br J Rheumatol 1993; 32:116. 
2. Rackow BW, Arici A. Reproductive performance of women with müllerian anomalies. Curr Opin Obstet Gynecol 2007; 19:229.
3. Kaufman RH, Adam E, Hatch EE, et al. Continued follow-up of pregnancy outcomes in diethylstilbestrol-exposed offspring. Obstet Gynecol 2000; 96:483.
4. Vyas NA, Vink JS, Ghidini A, et al. Risk factors for cervical insufficiency after term delivery. Am J Obstet Gynecol 2006; 195:787.
5. Johnstone FD, Beard RJ, Boyd IE, McCarthy TG. Cervical diameter after suction termination of pregnancy. Br Med J 1976; 1:68.
6. Shah PS, Zao J, Knowledge Synthesis Group of Determinants of preterm/LBW births. Induced termination of pregnancy and low birthweight and preterm birth: a systematic review and meta-analyses. BJOG 2009; 116:1425.
7. Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth. A meta-analysis. Obstet Gynecol.  2011;117(3):663-671.
8. Owen J, Hankins G, Iams JD, et al. Multi-center randomized trial of cerclage for prevention of preterm birth in high-risk women with shortened mid-trimester cervical length. Am J Obstet Gynecol.  2009;201:375.e1-8.
9. Iams JD, Berghella V. Care for women with prior preterm birth. Am J Obstet Gynecol. 2010;203:89.e1-11.
10. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH. Fetal medicine foundation second trimester screening group. Progesterone and the risk of preterm birth among women with short cervix. N Engl J Med.  2007;357(5):462-469.
11. Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol  2012;206:124.e1-19.
12. SMFM. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol  2012;206:376-386.
13. Meis PJ, Klebanoff M, Thom E, et al. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha hydroxyprogesterone caproate. N Eng J Med. 2003;348:2379-2385.
14. Keeler SM, Kiefer D, Rochon M, et al. A randomized trial of cerclage vs. 17 alpha-hydroxyprogesterone caproate for treatment of short cervix. J Perinat Med. 2009;37:473-479.
15. McDonald IA. Suture of the cervix for inevitable miscarriage. J Obstet Gynaecol Br Emp 1957; 64:346.
16. Shirodkar, VN. A new method of operative treatment for habitual abortion in the second trimester of pregnancy. Antiseptic 1955; 52:299.
17. Yoon HJ, Hong JY, Kim SM. The effect of anesthetic method for prophylactic cervical cerclage on plasma oxytocin: a randomized trial. Int J Obstet Anesth 2008; 17:26.
18. Ludmir J, Jackson GM, Samuels P. Transvaginal cerclage under ultrasound guidance in cases of severe cervical hypoplasia. Obstet Gynecol 1991; 78:1067.
19. Odibo AO, Berghella V, To MS, et al. Shirodkar versus McDonald cerclage for the prevention of preterm birth in women with short cervical length. Am J Perinatol 2007; 24:55.
20. Final report of the Medical Research Council/Royal College of Obstetricians and Gynaecologists multicentre randomised trial of cervical cerclage. MRC/RCOG Working Party on Cervical Cerclage. Br J Obstet Gynaecol 1993; 100:516.
21. Harger JH. Comparison of success and morbidity in cervical cerclage procedures. Obstet Gynecol 1980; 56:543.
22. Rush RW, Isaacs S, McPherson K, et al. A randomized controlled trial of cervical cerclage in women at high risk of spontaneous preterm delivery. Br J Obstet Gynaecol 1984; 91:724.
23. Lazar P, Gueguen S, Dreyfus J, et al. Multicentred controlled trial of cervical cerclage in women at moderate risk of preterm delivery. Br J Obstet Gynaecol 1984; 91:731.
24. www.abbyloopers.com
25. Zaveri V, Aghajafari F, Amankwah K, Hannah M. Abdominal versus vaginal cerclage after a failed transvaginal cerclage: a systematic review. Am J Obstet Gynecol 2002; 187:868.
26. Lotgering  FK, Gaugler-Sender IP, Lotgering SF, Wallenburg HC. Outcome after transabdominal cervico-isthmic cerclage.  Obstet Gynecol.  2006;107:779-784.
27. Debbs RH, DeLa Vega GA, Pearson S, et al. Transabdominal cerclage after comprehensive evaluation of women with previous unsuccessful transvaginal cerclage. Am J Obstet Gynecol 2007; 197:317.e1.
28. Whittle WL, Singh SS, Allen L, Glaude L, et al. Laparoscopic cervico-isthmic cerclage: surgical technique and obstetric outcomes.  Am J Obstet Gynecol  2009;201:364.e1-7.
29. Burger NB, Brolmann AM, Einarsson JI, Langebrekke A, Huirne AF. Effectiveness of abdominal cerclage placed via laparotomy or laparoscopy: systematic review. J Min Invas Gynecol. 2011;18:696-704

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