Transabdominal Cerclage

Number: 0529

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses transabdominal cerclage.

1. Medical Necessity

   Aetna considers transabdominal cerclage medically necessary for the treatment of an incompetent cervix for any of the following conditions:

   1. Deep traumatized cervix; or
   2. Previous failed cervical (transvaginal) cerclages; or
   3. Shortened (less than 2.5 cm) or amputated cervix, or
   4. Transabdominal placement of a cervical cerclage for cervical incompetence prior to conception via laparoscopy or laparotomy.
      

      Note: A history consistent with incompetent cervix must be documented to establish the medical necessity of this procedure. This includes a history of mid-trimester pregnancy loss that is associated with painless cervical dilatation without evidence of uterine activity.

2. Experimental, Investigational, or Unproven

   Aetna considers transabdominal cerclage experimental, investigational, or unproven for all other indications (e.g., prophylactic cerclage for multiple gestations) because of insufficient evidence of effectiveness.

3. Related Policies

   1. CPB 0327 - Infertility
   2. CPB 0530 - Transvaginal Ultrasonography

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Table:

CPT Codes/ HCPCS Codes / ICD-10 Codes

Code	Code Description
CPT codes covered if selection criteria are met:
57700	Cerclage of uterine cervix, nonobstetrical [cervical incompetence prior to conception]
59325	Cerclage of cervix, during pregnancy; abdominal
ICD-10 codes covered if selection criteria are met:
N88.3	Incompetence of cervix uteri
O34.30 - O34.33	Maternal care for cervical incompetence
O34.40 - O34.43	Maternal care for other abnormalities of cervix [shortened, amputated, or deep traumatized cervix]
ICD-10 codes not covered for indications listed in the CPB:
O30.001 - O30.93	Multiple gestation

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Background

Incompetent cervix is a significant cause of second-trimester pregnancy loss. It is characterized by gradual, painless dilation of the cervix in the second or third trimester, with bulging and rupture of the membranes and subsequent expulsion of a fetus too immature to survive.

Cervical incompetence may be due to previous obstetric or gynecological trauma or a congenital weakness of the cervix (NICE, 2007). The condition is usually diagnosed after one or more late second-trimester or early third-trimester pregnancy losses, and after other causes have been excluded.

The role of cervical cerclage in the prevention of miscarriage due to cervical incompetence is well established yet remains controversial. The most commonly employed techniques are performed vaginally and are designed to reinforce the cervix at the level of the internal os. This involves placing a stitch of strong thread or tape around the cervix via the vagina and tightening it to keep the cervix closed. The procedure is typically performed at the end of the first trimester or the beginning of the second trimester, and the stitch is usually removed at around 37 weeks’ gestation (NICE, 2007).

If there is insufficient cervical tissue to allow placement of a cerclage vaginally, a transabdominal approach (either open or laparoscopic) is sometimes used. With this procedure, an encircling suture is placed above the cardinal and uterosacral ligaments. Transabdominal cerclage is not frequently performed and is only indicated for those patients with previous failed cervical cerclages, shortened or amputated cervix, and/or deep traumatized cervix. This procedure should only be performed by physicians with special training and expertise in this procedure.

The clinical value of pre-pregnancy cerclage has not been firmly established. In a meta-analysis, Drakeley and colleagues (2003) stated that the effectiveness of prophylactic cerclage in preventing preterm delivery in women at low or medium risk for second-trimester pregnancy loss has not been proven. The role of cerclage in women whose ultrasound reveals a short cervix remains uncertain. Shennan and Jones (2004) stated that elective cerclage is only effective in a minority of women, and the evidence to support its use is limited. It is currently being evaluated whether indicated cerclage, dictated by ultrasound findings, is beneficial.

The Royal College of Obstetricians and Gynaecologists' guideline on the investigation and treatment of couples with recurrent miscarriage (2003) did not mention the use of pre-pregnancy cerclage. Furthermore, the American College of Obstetricians and Gynecologists' guideline on cervical insufficiency (2003) stated that elective cerclage can be considered in patients with a history of three or more unexplained mid-trimester pregnancy losses or preterm deliveries. Moreover, cerclage should be performed at 13 to 16 weeks' gestation after ultrasound evaluation has shown the presence of a live fetus with no apparent anomalies.

Guidance from the National Institute for Health and Clinical Excellence (2007) stated that the evidence on the safety and efficacy of laparoscopic cerclage for the prevention of recurrent pregnancy loss due to cervical incompetence is limited, and therefore this procedure should not be used without special arrangements for consent and for audit or research. The Specialist Advisers to NICE considered this procedure to be novel and expressed uncertainty about its efficacy. They listed key efficacy outcomes of laparoscopic cerclage as live birth rate, ‘take-home baby’ rate, prolongation of pregnancy, reduction in perioperative morbidity and perinatal morbidity, operating times, and blood loss. The NICE guidance noted that there is uncertainty about the efficacy of all cervical cerclage techniques as a treatment for recurrent loss of pregnancy due to cervical incompetence. The NICE Committee noted specific concerns about performing the procedure in women who are not pregnant. These include the difficulty in defining the internal os for correct placement of the suture and ensuring that the suture is not tied in such a way that there is a risk of it cutting through the cervix during subsequent pregnancy.

The American College of Obstetricians and Gynecologists (ACOG)’s practice bulletin on "Cerclage for the management of cervical insufficiency" (ACOG, 2014a) stated that "Transabdominal cervicoisthmic cerclage generally is reserved for patients in whom a cerclage is indicated based on the diagnosis of cervical insufficiency but cannot be placed because of anatomical limitations (e.g., after a trachelectomy), or in the case of failed transvaginal cervical cerclage procedures that resulted in second-trimester pregnancy loss."

Rafael et al. (2014) stated that cervical cerclage is a surgical intervention involving placing a stitch around the uterine cervix. The suture material aims to prevent cervical shortening and opening, thereby reducing the risk of preterm birth. The effectiveness and safety of this procedure in multiple gestations remain controversial. In a Cochrane review, these investigators examined if the use of a cervical cerclage in multiple gestations, either at high risk of pregnancy loss based on just the multiple gestation (history-indicated cerclage), the ultrasound findings of "short cervix" (ultrasound-indicated cerclage), or the physical exam changes in the cervix (physical exam-indicated cerclage), improves obstetrical and perinatal outcomes. The primary outcomes assessed were perinatal deaths, serious neonatal morbidity, and perinatal deaths and serious neonatal morbidity. These investigators searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 30, 2014) and reference lists of retrieved studies. All randomized controlled trials (RCTs) of cervical cerclage in multiple pregnancies were selected for review. Quasi-RCTs and RCTs using a cluster-randomized design were eligible for inclusion (but none was identified). Studies using a crossover design and those presented only as abstracts were not eligible for inclusion. These researchers included studies comparing cervical cerclage with no cervical cerclage in multiple pregnancies. Studies comparing cervical stitch versus any other preventative therapy (e.g., progesterone) in multiple pregnancies, and studies involving comparisons between different cerclage protocols (history-indicated versus ultrasound-indicated versus physical exam-indicated cerclage) were also eligible for inclusion, but none was identified. Two review authors independently assessed trials for inclusion and risk of bias. Two review authors extracted data. Data were checked for accuracy. These researchers included five trials, which in total randomized 1,577 women, encompassing both singleton and multiple gestations. After excluding singletons, the final analysis included 128 women, of which 122 women had twin gestations, and six women had triplet gestations. Two trials (n = 73 women) assessed history-indicated cerclage, while three trials (n = 55 women) assessed ultrasound-indicated cerclage. The five trials were judged to be of average to above-average quality, with three of the trials at unclear risk regarding selection and detection biases. Concerning the primary outcomes, when outcomes for cerclage were pooled together for all indications and compared with no cerclage, there were no statistically significant differences in perinatal deaths (19.2% versus 9.5%; risk ratio [RR] 1.74, 95% confidence intervals [CI]: 0.92 to 3.28, five trials, n = 262), serious neonatal morbidity (15.8% versus 13.6%; average RR 0.96, 95% CI: 0.13 to 7.10, three trials, n = 116), or composite perinatal death and neonatal morbidity (40.4% versus 20.3%; average RR 1.54, 95% CI: 0.58 to 4.11, three trials, n = 116). Among the secondary outcomes, there were no significant differences between the cerclage and the no cerclage groups. To name a few, there were no significant differences among the following: preterm birth less than 34 weeks (average RR 1.16, 95% CI: 0.44 to 3.06, four trials, n = 83), preterm birth less than 35 weeks (average RR 1.11, 95% CI: 0.58 to 2.14, four trials, n = 83), low birth weight less than 2,500 g (average RR 1.10, 95% CI: 0.82 to 1.48, four trials, n = 172), very low birth weight less than 1,500 g (average RR 1.42, 95% CI: 0.52 to 3.85, four trials, n = 172), and respiratory distress syndrome (average RR 1.70, 95% CI: 0.15 to 18.77, three trials, n = 116). There were also no significant differences between the cerclage and no cerclage groups when examining cesarean section (elective and emergency) (RR 1.24, 95% CI: 0.65 to 2.35, three trials, n = 77) and maternal side effects (RR 3.92, 95% CI: 0.17 to 88.67, one trial, n = 28). Examining the differences between pre-specified subgroups, ultrasound-indicated cerclage was associated with an increased risk of low birth weight (average RR 1.39, 95% CI: 1.06 to 1.83, Tau² = 0.01, I² = 15%, three trials, n = 98), very low birth weight (average RR 3.31, 95% CI: 1.58 to 6.91, Tau² = 0, I² = 0%, three trials, n = 98), and respiratory distress syndrome (average RR 5.07, 95% CI: 1.75 to 14.70, Tau² = 0, I² = 0%, three trials, n = 98). However, given the low number of trials, as well as substantial heterogeneity and subgroup differences, these data must be interpreted cautiously. No trials reported on long-term infant neurodevelopmental outcomes. There were no physical exam-indicated cerclages available for comparison among the studies included. The authors concluded that the findings of this review were based on limited data from five small studies of average to above-average quality. They stated that for multiple gestations, there is no evidence that cerclage is an effective intervention for preventing preterm births and reducing perinatal deaths or neonatal morbidity.

The ACOG’s practice bulletin on "Multifetal gestations: Twin, triplet, and higher-order multifetal pregnancies" (ACOG, 2014b) stated that "Interventions, such as prophylactic cerclage, prophylactic tocolytics, prophylactic pessary, routine hospitalization, and bed rest, have not been proved to decrease neonatal morbidity or mortality and, therefore, should not be used in women with multifetal gestations."

Saccone et al. (2015) evaluated the effectiveness of cerclage for preventing preterm birth in twin pregnancies with a short cervical length (CL). Searches were performed in electronic databases. These investigators performed an individual patient data meta-analysis of randomized trials of twin pregnancies screened by transvaginal ultrasound in the second trimester and where mothers had a short CL of less than 2.5 cm before 24 weeks. Eligible women had to be randomized to cerclage versus no-cerclage (control). The primary outcome was preterm birth less than 34 weeks. A total of three trials with 49 twin gestations with a short CL were identified. All original databases for each included trial were obtained from the primary authors. Risk factors were similar in the cerclage and control groups, except that previous preterm birth was more frequent and gestational age at randomization and delivery were earlier in the cerclage group compared with the control group. Adjusting for previous preterm birth and gestational age at randomization, there were no statistically significant differences in primary (adjusted odds ratio [OR] 1.17, 95% CI: 0.23 to 3.79) and secondary outcomes. Rates of very low birth weight and of respiratory distress syndrome were significantly higher in the cerclage group than in the control group. The authors concluded that based on these Level 1 data, cerclage cannot currently be recommended for clinical use in twin pregnancies with a maternal short CL in the second trimester. They stated that large trials are still needed.

Song et al. (2015) examined pregnancy outcomes following transabdominal cerclage (TAC) in women with cervical insufficiency and explored parameters for predicting pregnancy outcomes following TAC. In this retrospective cohort study, these investigators included 161 women with TAC. They considered demographic, obstetric, and gynecologic histories, pre- and post-operative CL, and CL at 20 to 24 weeks as parameters for predicting outcomes following TAC. Univariate and multivariate analyses were used to identify risk factors for predicting delivery before 34 weeks after TAC. A total of 182 pregnancies occurred after TAC, and 290 pregnancies prior to TAC were identified. The rate of delivery less than 34 weeks significantly decreased following TAC (5% versus 82%, p < 0.001). Univariate analysis demonstrated that a short CL (less than 2.5 cm) at 20 to 24 weeks and adenomyosis were associated with delivery at less than 34 weeks' gestation following TAC (p = 0.015 and p = 0.005, respectively). However, multivariate analysis demonstrated that only a short CL (less than 2.5 cm) at 20 to 24 weeks was a significant predictor (p = 0.005). The authors concluded that TAC is an effective procedure that prolongs pregnancy in women with cervical insufficiency. A short CL at 20 to 24 weeks may predict delivery at less than 34 weeks' gestation following TAC.

Groom et al. (2004) conducted a study to report pregnancy outcomes and complication rates for women with recurrent late pregnancy loss who were treated with preconception transabdominal cervicoisthmic cerclage. They implemented a case note review of 19 women who were treated with preconception transabdominal cervicoisthmic cerclage at Queen Charlotte's and Chelsea Hospital from 1994 to 2003 and were at high risk for second-trimester loss and early preterm delivery. The results showed that preconception transabdominal cervicoisthmic cerclage was associated with a postoperative fetal survival rate of 100% for pregnancies that reached >12 weeks of gestation, compared with a preoperative fetal survival rate of 12%. No significant intraoperative, antenatal, intrapartum, or neonatal complications were reported. The investigators concluded that within this case series, preconception transabdominal cervicoisthmic cerclage was a safe alternative to transabdominal cervicoisthmic cerclage that was performed in pregnancy with no risk to a fetus.

Tulandi et al. (2014) conducted a study to evaluate the efficacy of abdominal cerclage via laparoscopy versus laparotomy. The evaluation was conducted both before and after conception. The investigators evaluated 16 studies published between 1990 and 2013 involving a total of 678 cases in which abdominal cerclage was studied. A generalized linear model was used to estimate the effect of laparotomy over laparoscopy and the effect of preconceptional over postconceptional cerclage by treating the success rates (third-trimester delivery and live birth) as dependent variables and laparotomy and preconceptional as independent factors. The results showed no difference in the rates of third-trimester delivery and live birth rates between preconceptional abdominal cerclage via laparoscopy (71.4%-83.3% and 90%-100%, respectively) or laparotomy (97.3%-100% and 100%, respectively). In cases of postconceptional cerclage, the rates of third-trimester delivery and live birth via laparoscopy were 70% and 70% to 100%, respectively, and via laparotomy were 77.4% to 99.5% and 85.2% to 100%, respectively. Performing abdominal cerclage before or during pregnancy resulted in no difference in the live birth rates. The authors concluded that the rates of third-trimester delivery and live birth after abdominal cerclage via laparoscopy are high and comparable to those via laparotomy. They further noted that the efficacy of the procedure performed either before or during pregnancy is similar, although abdominal cerclage performed before conception is more practical than after conception. In particular, when performed in non-pregnant women, there is an inherent advantage of laparoscopy over laparotomy. Thus, laparoscopy is preferable in non-pregnant women.

Dawood and Farquharson (2016) stated that TAC is an effective intervention to prevent spontaneous mid-trimester loss and preterm delivery when a transvaginal cerclage has failed. A TAC may be inserted during the first trimester (T1) of pregnancy or pre-conceptually. In a retrospective and prospective cohort study, these investigators determined whether or not pre-conceptual (PC) TAC confers any benefit over T1 TAC insertion in terms of associated surgical and pregnancy-related morbidity and subsequent pregnancy outcome. This study included 161 consecutive women who underwent PC TAC versus T1 TAC over a 22-year period from January 1993 to January 2015 at a tertiary referral miscarriage clinic. Data were obtained from case note review retrospectively from 1993 to 2006 and prospectively between 2006 and 2015. Inclusion criteria comprised a history of at least one previous spontaneous mid-trimester loss coupled with at least one failed transvaginal cerclage and screening for anti-phospholipid syndrome and bacterial vaginosis. Of 144 patients who conceived, 121 had complete pregnancy outcomes: 62 in the PC group and 59 in the T1 group. Both groups had similar previous pregnancy losses and previous transvaginal cerclage history. Successful pregnancies of greater than 24 weeks occurred in 97% of PC TACs compared to 93% in the T1 group. Furthermore, a successful pregnancy of greater than 34 weeks occurred in 90% (56/62) in the PC group compared to 74% (44/59) in the T1 group (OR 3.18; CI: 1.14 to 8.8). Significantly fewer patients needed emergency cesarean sections for preterm delivery in the PC group (7/62 [12%] versus 21/59 [36%]; OR 4.34; CI: 1.68 to 11.32). All six failures before 24 weeks gestation (T1 = 4, PC = 2) were associated with anti-phospholipid syndrome or bacterial vaginosis. In the T1 group, 3/65 (5%) of patients suffered serious surgical complications, and hemorrhage of 500 mls occurred in 32/65 (50%) of cases, whereas no surgical complications occurred in the PC group. The authors concluded that PC TAC was more successful in preventing repeat spontaneous mid-trimester loss and preterm labor and was associated with less surgical and pregnancy-related morbidity compared to T1 TAC insertion.

In a retrospective audit, Hall and van de Vyver (2023) described the pregnancy outcomes and complications observed in a series of cases of TAC, which is reserved for highly selected women with recurrent mid-trimester pregnancy loss due to cervical incompetence (CI). This audit covered 25 years (January 1, 1997, to December 31, 2021) and was carried out at the Obstetric Special Care division, Tygerberg Academic Hospital in Cape Town, South Africa. All 118 pregnancies from 94 procedures, operated and managed by the principal author, were included for descriptive analysis. A total of 84 (91.3%) of the 92 first pregnancies after the first insertion had successful outcomes. All second and third pregnancies (24/24; 100%) were successful; eight pregnancies did not achieve viability, and two women (2/8) did, however, achieve a successful pregnancy following a subsequent repeat TAC procedure. For the viable pregnancies (110/118), the median gestational age at delivery was 37 weeks (range of 28 to 39 weeks). The median intra-operative blood loss during cerclage insertion was 100 ml (range of 25 to 750 ml). The authors concluded that in experienced hands, TAC during pregnancy was a safe and effective operation when other less invasive procedures have failed.

On behalf of the Society for Maternal-Fetal Medicine (SMFM) Publications Committee, Temming and Mikhail (2023) noted that cerclage is the mainstay of treatment for CI. While TAC may have advantages over transvaginal cerclage, it is associated with increased morbidity and the need for cesarean delivery. These investigators examined the available evidence on the risks and benefits of TAC and provided recommendations based on the available evidence. The following are SMFM recommendations:

1. Recommended that TAC be offered to patients with a previous placement of transvaginal cerclage (history or US indicated) and subsequent singleton delivery before 28 weeks of gestation. (GRADE 1B).
2. Recommended that maternal-fetal medicine consultation for counseling patients who may be candidates for TAC and those who have undergone TAC (Best Practice).
3. Suggested that both laparoscopic and open TAC are acceptable; and the decision of approach may depend on gestational age, technical feasibility, available resources, and expertise (GRADE 2B).
4. Suggested that TAC can be performed pre-conceptionally or in the 1st trimester with similar fetal outcomes.  If a patient with an indication for TAC presents after the 1st trimester, TAC can still be considered before 22 weeks (GRADE 2C).
5. Recommended that routine transvaginal cervical length screening not be performed for patients with TAC in-situ (GRADE 1C).
6. Suggested that for individuals at risk of recurrent spontaneous preterm birth, including those with TAC i- situ, a risk/benefit discussion of supplemental progesterone be undertaken with shared decision-making (GRADE 2C).
7. Suggested that pregnancy loss be managed with dilation and curettage or evacuation with TAC in-situ or via usual obstetric management after laparoscopic removal of TAC, depending on gestational age and resources available (GRADE 2C).
8. Suggested cesarean delivery between 37 0/7 to 39 0/7 weeks for patients with TAC in-situ (GRADE 2C).

Transabdominal Cerclage Placement via Laparoscopy or Laparotomy

Hulshoff et al. (2023) noted that CI is a major cause of 2nd-trimester pregnancy loss and spontaneous preterm delivery. Transabdominal cervico-isthmic cerclage is usually carried out before pregnancy for patients of CI, in whom transvaginal cervical cerclage procedure cannot be placed or has failed previously. Performing a TAC becomes a huge challenge owing to the enlargement of the pregnant uterus in patients who were indicated for transabdominal cervico-isthmic cerclage but were missed before pregnancy. These investigators outlined an easy and effective surgical procedure as needle-free laparoscopic trans-broad-ligament cervico-isthmic cerclage during early 2nd-trimester. Laparoscope with 4 trocars was established, after expanding the trigonum of ureter, ovarian vascular and ascending branch of uterine artery. The needleless Mersilene tape was inserted in a posterior-to-anterior direction of bilateral trigonums, tightening the knot toward the bladder uterine reflection and simultaneously pushing the loop behind the uterus, directed to the cervix progressively. The tape was then tied anteriorly at the cervico-isthmic junction with 5 to 6 intra-corporeal square knots after transvaginal US determined the presence of systolic velocity of uterine artery with 1st knot. The primary feature of this procedure was that the needleless Mersilene tape was inserted centrally from the broad ligaments, lateral to the uterine vessels, and finally tied above the utero-sacral ligament at the level of the uterine isthmus, without dissecting the bladder off from lower uterine segment and without separating the uterine vessels from the lateral wall of the cervix. These researchers carried out this procedure on 10 patients with pregnancy outcomes and there was no pregnancy loss. The authors concluded that this procedure proved to be an accessible and effective surgical technique for TAC of the uterine cervix during early 2nd-trimester, with affirmative prognosis.

Cervical Cerclage in Combination with Other Treatments for Prevention of Spontaneous Preterm Birth

Eleje and colleagues (2020) noted that preterm birth (PTB) remains the foremost global cause of perinatal morbidity and mortality; therefore, the prevention of spontaneous PTB is still of critical importance. In an attempt to prevent PTB in singleton pregnancies, cervical cerclage, in combination with other treatments, has been advocated. This is because cervical cerclage is an intervention that is commonly recommended for women with a short cervix at high risk of PTB; however, despite this, many women still deliver prematurely, as the biological mechanism is incompletely understood. Furthermore, previous Cochrane Reviews have been published on the effectiveness of cervical cerclage in singleton and multiple pregnancies; however, none has examined the effectiveness of using cervical cerclage in combination with other treatments. In a Cochrane review, these researchers examined whether the administration of antibiotics, vaginal pessary, reinforcing or second cerclage placement, tocolytic, progesterone, or other interventions at the time of cervical cerclage placement would prolong singleton gestation in women at high risk of pregnancy loss based on prior history and/or ultrasound (US) findings of “short cervix” and/or physical examination. History-indicated cerclage is defined as a cerclage placed usually between 12 and 15 weeks of gestation based solely on poor prior obstetrical history, e.g., multiple second-trimester losses due to painless dilatation. Ultrasound-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks of gestation for transvaginal ultrasound (TVUS) cervical length of less than 20 mm in a woman without cervical dilatation. Physical examination-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks of gestation because of cervical dilatation of 1 cm or more detected on physical (manual) examination. These investigators searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) (September 26, 2019), as well as reference lists of retrieved studies. They included published, unpublished, or ongoing randomized controlled trials (RCTs). Studies using a cluster-RCT design were also eligible for inclusion in this review; however, none was identified. These researchers excluded quasi-RCTs (e.g., those randomized by date of birth or hospital number) and studies using a crossover design. They also excluded studies that specified the addition of combination therapy after cervical cerclage because the woman subsequently became symptomatic. They included studies comparing cervical cerclage in combination with one, two, or more interventions with cervical cerclage alone in singleton pregnancies. Two review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias, and evaluated the certainty of the evidence for this review's main outcomes. Data were checked for accuracy; standard Cochrane review methods were used throughout.

These researchers identified two studies (involving a total of 73 women) comparing cervical cerclage alone to a different comparator. They also identified three ongoing studies (one examining vaginal progesterone after cerclage and two examining cerclage plus pessary). One study (n = 20 women), conducted in the United Kingdom, comparing cervical cerclage in combination with a tocolytic (salbutamol) with cervical cerclage alone in women with singleton pregnancy did not provide any usable data for this review. The other study (with data from 50 women) took place in the United States and compared cervical cerclage in combination with a tocolytic (indomethacin) and antibiotics (cefazolin or clindamycin) versus cervical cerclage alone. This study did provide usable data for this review (and the study authors also provided additional data on request), but meta-analyses were not possible. This study was generally at a low risk of bias, apart from issues relating to blinding. These investigators downgraded the certainty of evidence for serious risk of bias and imprecision (few subjects, few events, and wide 95% CI). Cervical cerclage in combination with an antibiotic and tocolytic versus cervical cerclage alone (one study, 50 women/babies). These researchers were unclear regarding the effect of cervical cerclage in combination with antibiotics and a tocolytic compared with cervical cerclage alone on the risk of serious neonatal morbidity (RR 0.62, 95% CI: 0.31 to 1.24; very low-certainty evidence); perinatal loss (data for miscarriage and stillbirth only – data not available for neonatal death) (RR 0.46, 95% CI: 0.13 to 1.64; very low-certainty evidence); or PTB of less than 34 completed weeks of pregnancy (RR 0.78, 95% CI: 0.44 to 1.40; very low-certainty evidence). There were no stillbirths (intrauterine death at 24 or more weeks). The trial authors did not report on the numbers of babies discharged home healthy (without obvious pathology) or on the risk of neonatal death. The authors concluded that there is insufficient evidence to examine the effect of combining a tocolytic (indomethacin) and antibiotics (cefazolin/clindamycin) with cervical cerclage compared with cervical cerclage alone for preventing spontaneous PTB in women with singleton pregnancies. Future studies should recruit sufficient numbers of women to provide meaningful results and should measure neonatal death and the numbers of babies discharged home healthy, as well as other important outcomes.

Sunami et al. (2022) examined the usefulness of modified transabdominal cervico-isthmic cerclage (TAC) using monofilament thread for the prevention of PTD in women with an extremely short cervix after deep conization. These researchers devised a monofilament thread for picking up the seromuscular layer of the site that is slightly cephalad to the internal ostium to prevent injury to the vessels around the uterine cervix. From 2017 to 2020, these investigators performed this modified operation in eight women (nine pregnancies) at 12 to 16 weeks of gestation with a history of deep cervical conization. A modified TAC was successfully performed in all patients. There was no measurable bleeding, and all patients were discharged without postoperative complications. Their pregnancy courses after the operation were uneventful. Of the nine pregnancies, one patient had premature uterine contractions and underwent cesarean section at 36 weeks (PTD). In the other eight pregnancies, a planned cesarean section was performed after 37 weeks of gestation. The median birth weight of the babies was 2,996 g (range of 2,604 to 3,374 g). All patients were discharged on the sixth postoperative day without complications. The authors concluded that a modified TAC could be safely carried out and may prolong pregnancy without adverse events (AEs) in patients with an extremely short cervix.

Zhao et al. (2022) stated that cervical incompetence (CI) is a major cause of second-trimester pregnancy loss and spontaneous PTD; TAC is usually carried out prior to pregnancy for patients with CI, in whom the transvaginal cervical cerclage procedure cannot be placed or has failed previously. Performing a TAC becomes a huge challenge owing to the enlargement of the pregnant uterus in patients who were indicated for TAC but were missed before pregnancy. These investigators outlined an easy and effective surgical procedure as needle-free laparoscopic trans-broad-ligament cervico-isthmic cerclage during early second trimester. A laparoscope with four trocars was established after expanding the trigonum of the ureter, ovarian vascular, and ascending branch of the uterine artery. The needleless Mersilene tape was inserted in a posterior-to-anterior direction of bilateral trigonums, tightening the knot toward the bladder-uterine reflection and simultaneously pushing the loop behind the uterus, directed to the cervix progressively. The tape was then tied anteriorly at the cervico-isthmic junction with five to six intracorporeal square knots after transvaginal US determined the presence of systolic velocity of the uterine artery with the first knot. The primary feature of this procedure was that the needleless Mersilene tape was inserted centrally from the broad ligaments, lateral to the uterine vessels, and finally tied above the uterosacral ligament at the level of the uterine isthmus, without dissecting the bladder off from the lower uterine segment and without separating the uterine vessels from the lateral wall of the cervix. The authors performed this procedure on ten patients with pregnancy outcomes, and there was no pregnancy loss. This procedure proved to be an accessible and effective surgical technique for TAC of the uterine cervix during early second trimester, with an affirmative prognosis.

Corbett et al. (2024) noted that transabdominal cerclage is an effective surgical intervention for PTB prevention. Placement of cervical sutures using a port closure device for pre-pregnancy laparoscopic abdominal cerclage has been used at the authors’ unit in recent years. These investigators reported the operative and pregnancy outcomes for pre-pregnancy laparoscopic abdominal cerclage using the port closure device and compared it with the outcomes of the traditional approach. For pre-pregnancy laparoscopic transabdominal cerclage (n = 52), the port closure device approach was associated with less blood loss during surgery (0.95 ± 4.4 ml versus 5.4 ± 15.7 ml; p = 0.007) and a shorter hospital length of stay (LOS) (0.0; 0.0 to 0.0 days versus 1.0; 0.0 to 1.0 days; p < 0.001). There were also trends toward shorter operating times (41.4 ± 15.3 mins versus 50.1 ± 18.0 mins; p = 0.167) and lower perioperative complication rates (0.0%; 0/21 versus 16.1%; 5/31; p = 0.065) when compared with the traditional technique. There was no significant difference between the port closure device technique and the traditional approach in the rate of PTB in a subsequent pregnancy (0.0%; 0/9 versus 22.6%; 7/39; p = 0.248). The use of the port closure device for suture placement during pre-pregnancy laparoscopic cerclage for PTB prevention was reported. This technique was associated with less blood loss and a shorter hospital LOS, had trends toward shorter operating times and lower perioperative complication rates, and had similar rates of PTB.

Modified Laparoscopic Trans-Abdominal Cervico-Isthmic Cerclage for the Management of Refractory Cervical Insufficiency / Recurrent Pregnancy Loss

In a retrospective, single-center study, Wang et al. (2020) reported on their center's experience with a novel modified approach for laparoscopic cervical cerclage and examined its safety and effectiveness preliminarily. Subjects were pregnant and non-pregnant women who underwent the modified laparoscopic transabdominal cervical cerclage with transvaginal removal (MLTCC-TR) from June 2016 to April 2019. Eligible participants had multiple adverse obstetric histories or a short cervix and were not suitable for a second transvaginal cerclage. Subjects underwent pre-conceptional or post-conceptional MLTCC-TR. A total of 24 participants (including three first-trimester singleton pregnant women) underwent the MLTCC-TR, giving birth to 27 infants. Among 21 women who underwent pre-conceptional cerclage, 26 cases of post-operative pregnancies were noted, and the incidence of term labor was 73.07%, which was significantly higher than that in the pre-cerclage group (p < 0.001). Their mean gestational age at delivery was 37.21 ± 5.05 weeks. Among three cases of post-conceptional cerclage, the mean gestational age at cerclage was 10.90 ± 2.61 weeks, and all of them had term delivery. The overall neonatal survival rate was 100% (27/27), of which 81.48% (22/27) were term infants. There were no severe peri-operative complications directly related to the insertion of cerclage. The authors concluded that this new approach of MLTCC-TR may be a relatively effective, feasible, and safe treatment for cervical insufficiency. It may be considered an acceptable alternative to the traditional laparoscopic cervical cerclage with its superiority of transvaginal removal. These preliminary findings from a retrospective, single-center trial need to be validated by well-designed studies.

In a retrospective, observational study, Chung et al. (2021) examined the feasibility of MLTCC and its impact on recurrent pregnancy loss (RPL). Subjects were patients (n = 299) who underwent MLTCC from 2003 to 2018. The surgery was carried out at a mean gestational age of 12.5 weeks (range of 10.5 to 17.5 weeks). Of the 299 patients, 190 were reported as having undergone abortion (1 abortion: 91 [47.9%], 2 abortions: 59 [31.1%], 3 or more abortions: 40 [21.1%]) before the present pregnancy and before the surgery. The mean operation time was 47.4 minutes (range of 15 to 100 minutes). These investigators followed up with 205 of the 299 patients and recorded their obstetric outcomes. There were 176 successful deliveries via cesarean section, and the fetal survival rate was 85.9% (176/205). The authors concluded that the findings of this trial suggested that MLTCC was a safe and feasible surgical option during pregnancy for patients with a history of RPL due to cervical factors.

The authors stated that this study was limited by the absence of a compatible control group and by losses to follow-up, which affected obstetric outcomes. Another limitation was that the procedure was carried out by only one experienced surgeon. Moreover, these researchers stated that most current laparoscopic transabdominal cerclage (TAC) series reported a fetal survival rate of greater than 90%, a fetal loss rate or miscarriage rate of less than 7%, and a spontaneous PTB rate of at most 5% to 10%. Yet, in this series, the fetal survival rate was only 86% and was further confounded by a greater than 10% miscarriage rate and greater than 10% PTB rate. The relatively low fetal survival rate in this study was thought to be influenced by the size and composition of the patient population. Many patients living in other regions or overseas visited only for surgery. They were referred by the obstetric team for LTCC because other surgical approaches, such as transvaginal cerclage or conventional laparotomic TAC, were considered unsuitable for them. All patients from nationwide were operated on regardless of underlying conditions that could complicate the surgical procedure, including adenomyosis, previous operation history, and pelvic adhesion.

In a single-arm clinical trial, Seo et al. (2025) examined the feasibility, safety, and outcomes of MLTCC in patients with refractory cervical insufficiency. This trial was carried out at a specialized center in Japan between December 2017 and May 2022. Various parameters related to patient demographics, surgical techniques, outcomes, and complications were evaluated. The study enrolled 30 women with a median age of 36 years. The MLTCC was technically successful in all cases. The delivery rate and fetal survival rate at 28 days in the third trimester were both 93%. A surgical complication entailing small bowel injury occurred in one case and was promptly repaired. No fetal complications or pregnancy losses occurred within 28 days of the procedure. Perinatal outcomes included a cesarean section rate of 93%, a neonatal intensive care unit (NICU) admission rate of 30%, and an overall fetal survival rate of 93%. Furthermore, no absence or reversal of end-diastolic flow in the uterine artery (UA) was identified at the time of cerclage in any of the cases. The authors concluded that the findings of this study showed the feasibility and safety of MLTCC for refractory cervical insufficiency. The procedure attained a high delivery rate in the third trimester and a good overall fetal survival rate. These findings highlighted the importance of anatomical precision during thread placement in MLTCC. These researchers stated that this technique is promising in the treatment of refractory cervical insufficiency and potentially preventing second-trimester losses and extreme PTBs.

Preconception Laparoscopic Transabdominal Cervical Cerclage

Saridogan and colleagues (2019) stated that a recent Cochrane review concluded that cervical cerclage reduced preterm birth before 37, 34, and 28 weeks of gestation and also probably reduced the risk of perinatal death. Transabdominal cerclage was developed for a subgroup in whom TVC had failed or was not possible. This approach appeared more effective in improving fetal survival rates or obstetric outcomes. Most commonly, transabdominal cervical cerclage is placed at laparotomy (open TAC), but with the advance of minimal access techniques, laparoscopic transabdominal cervical cerclage is replacing the traditional open operation. In a prospective case-series study, these researchers examined the outcomes of pre-conception laparoscopic TAC procedures. Data were prospectively collected from 54 women at high risk of second-trimester miscarriage and preterm delivery due to cervical insufficiency undergoing pre-conception laparoscopic TAC by a single operator. This included demographics, obstetric and gynecological history (including previous cervical cerclage procedures), surgical complication rates, conception, and subsequent pregnancy outcomes. There were 36 pregnancies progressing beyond the first trimester, with a "take home baby" rate of 89% (32/36), a live-birth rate of 92% (33/36), and a neonatal survival rate of 97% (32/33). The mid-trimester loss (MTL) rate was 8% (3/36), with delivery rates after 37 weeks of 75% (27/36), between 34 to 37 weeks of 8% (3/36), and between 23 to 34 weeks of 8% (3/36). The authors concluded that this prospective case-series study provided further evidence that laparoscopic TAC was feasible, safe, and effective when TVC failed or was not possible. Moreover, these researchers stated that comparative studies are likely to be difficult, but prospective data collection and the development of national or international registries are likely to produce further evidence on its use for wider indications.

The main drawbacks of this study were its relatively small sample size (n = 54) and the lack of a control group, especially for those who had not been pregnant before. It would be difficult to randomize women with a history of failed TVC; however, it may be possible to collect data from women who chose to have expectant management instead of laparoscopic TAC following cervical surgery causing absent ectocervix or short cervix.

Transabdominal Cerclage for Cervical Insufficiency in Multiple Gestations

Debieve and colleagues (2020) noted that the diagnosis of cervical insufficiency is based on the previous history of recurrent second or early third trimester losses. Its incidence among pregnant women is 0.5 to 1%, but it can be as high as 75% among women with preterm birth. Transvaginal cerclage (TVC) is the common therapy for cervical insufficiency. However, this technique has several limitations, especially in twin pregnancies. In some selected conditions, a TAC is indicated, and it has been offered to patients with multiple pregnancies. These investigators examined the outcomes of twin pregnancies with TAC in terms of preterm birth rate and neonatal morbidity and mortality. They conducted a retrospective study of seven patients with twin pregnancies managed with TAC at the end of the first trimester (12 to 15 weeks). These researchers selected patients with a history of fetal loss who met the indications criteria for TAC (history of TVC failure or short cervix unable to have TVC). The ante-natal and delivery data were collected and compared to those of their previous pregnancies. All patients carried their pregnancies throughout the second trimester and delivered during the third trimester. The mean gestational age was 34 4/7 weeks. All newborns were alive, and the neonatal morbidity rate was 50%, mostly related to preterm birth. The mean duration of neonatal intensive care stay was 32 days. There were no operative complications following TAC. The authors concluded that perinatal outcomes were considerably improved in twin pregnancies with TAC. These researchers stated that their findings corroborated with those of previous case reports and supported the efficacy of TAC for managing cervical insufficiency in twin pregnancies.

The evidence for transabdominal cerclage (TAC) in the management of cervical insufficiency in multiple gestations is limited and largely derived from low-quality observational data. No randomized controlled trial has specifically evaluated TAC in multiple gestations. The MAVRIC trial demonstrated that TAC reduces spontaneous preterm birth before 32 weeks compared to transvaginal cerclage in singletons with prior failed transvaginal cerclage (RR 0.23; 95% CI 0.07–0.76) (Shennan et al., 2020). The Society for Maternal-Fetal Medicine Consult Series #65 recommends TAC for patients with prior unsuccessful transvaginal cerclage and subsequent singleton delivery before 28 weeks (GRADE 1B), though this recommendation does not specifically address multiples (Temming et al., 2023). A Cochrane review of RCTs found no benefit of cerclage (predominantly transvaginal) in the multiple gestation subgroup, although the analysis was severely underpowered (n=128) (Rafael et al., 2014). More recent meta-analyses suggest that cerclage may reduce preterm birth in twins with cervical length <15 mm or cervical dilation, but these findings are driven exclusively by observational studies with low GRADE quality (D'Antonio et al., 2023; Li et al., 2019). A retrospective cohort from South Korea reported that TAC dramatically improved neonatal survival and reduced very preterm birth in 19 twin pregnancies with prior failed transvaginal cerclage, though the before-after design carries a high risk of bias (Son et al., 2020). A small Belgian case series of seven twin pregnancies with TAC reported favorable outcomes, with a mean delivery at 34 4/7 weeks and no operative complications (Debiève et al., 2020). A 2025 meta-analysis of TAC versus transvaginal cerclage across 12 studies found lower perinatal mortality (RR 0.36; 95% CI 0.14–0.95) and preterm birth (RR 0.49; 95% CI 0.25–0.94) with TAC. However, GRADE confidence was low due to heterogeneity and the predominance of observational studies, and multiple gestations were not analyzed separately (Bobotis et al., 2025). A multicenter factorial RCT in Vietnam comparing cervical cerclage versus pessary in 219 twin pregnancies with short cervix found no difference in preterm birth <34 weeks but significantly lower preterm birth <28 weeks (1% vs. 8.6%; RR 0.12; 95% CI 0.01–0.52) and perinatal death (1% vs. 5.8%; RR 0.17; 95% CI 0.05–0.62) with cerclage. However, the trial was halted early and used transvaginal rather than transabdominal cerclage (He et al., 2025). In summary, while TAC appears promising for select patients with multiple gestations and cervical insufficiency—particularly those with prior failed transvaginal cerclage or anatomic contraindications to vaginal placement—the current evidence base is insufficient to make definitive recommendations. Adequately powered randomized trials in this population are needed.

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References