Comparing cervical cerclage, pessary and vaginal progesterone for prevention of preterm birth in women with a short cervix (SuPPoRT): A multicentre randomised controlled trial.

BACKGROUND: Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT "Stitch, Pessary, or Progesterone Randomised Trial" was designed to compare the rate of PTB <37 weeks between each intervention in women who develop a short cervix in pregnancy. METHODS AND FINDINGS: SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks' gestation. Secondary outcomes included PTB <34 weeks', <30 weeks', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic. CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix. TRIAL REGISTRATION: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.

Cervical cerclage: An evolving evidence base.

Cervical cerclage is an established intervention for the management of pregnancies at high risk of preterm birth. Although studies exist to support its use in certain situations, particularly in singleton pregnancies, many questions such as adjunct therapies and efficacy in specific subgroups of high-risk women have not been fully elucidated. This review will assess the current evidence as well as areas where there is currently a paucity of data and an urgent requirement for further research.

Emergency cervical cerclage in delayed-interval delivery of twin pregnancies: a scoping review.

BACKGROUND: The protocol for delayed-interval delivery of the second twin in twin pregnancies has not been standardized. Cervical cerclage is often performed, but its use is debated. To conduct a scoping review on cervical cerclage for prolonging the intertwin delivery interval and improving second twin survival and maternal outcomes after preterm delivery or spontaneous abortion of the first twin in twin pregnancies. METHODS: Seven Chinese and English language databases were searched from inception to March 1, 2023, including PubMed, The Cochrane Library, Web of Science, CNKI, Wanfang Data, VIP Chinese Science Journal Database, and Sinomed. Relevant observational studies that assessed the effectiveness of the use of cervical cerclage in delayed-interval delivery of twins were screened and selected, and raw data were extracted, and descriptive statistics and chi-square analysis were performed. RESULTS: A total of 102 articles were retrieved. After screening and exclusion of duplicate and irrelevant articles, 22 articles meeting the inclusion criteria were obtained. Studies in which cerclage was performed reported longer intertwin delivery intervals than those that did not perform cerclage, and the difference was statistically significant. The cerclage group also tended to have lower rates of chorioamnionitis and maternal complications, but the difference between the two groups was not statistically significant. CONCLUSION: After excluding patients with contraindications, emergency cervical cerclage can be considered in cases of spontaneous abortion of the first twin in twin pregnancies to prolong the gestation and improve the prognosis of the remaining fetus until it becomes viable and increases its birth weight.

Development and validation of models for predicting preterm birth and gestational latency following emergency cervical cerclage: A multicenter cohort study.

INTRODUCTION: Emergency cervical cerclage is a recognized method for preventing mid-trimester pregnancy loss and premature birth; however, its benefits remain controversial. This study aimed to establish preoperative models predicting preterm birth and gestational latency following emergency cervical cerclage in singleton pregnant patients with a high risk of preterm birth. MATERIAL AND METHODS: We retrospectively reviewed data from patients who received emergency cerclage between 2015 and 2023 in three institutions. Patients were grouped into a derivation cohort (n = 141) and an independent validation cohort (n = 61). Univariate and multivariate logistic and Cox regression analyses were used to identify independent predictive variables and establish the models. Harrell's C-index, time-dependent receiver operating characteristic curves and areas under the curves, calibration curve, and decision curve analyses were performed to assess the models. RESULTS: The models incorporated gestational weeks at cerclage placement, history of prior second-trimester loss and/or preterm birth, cervical dilation, and preoperative C-reactive protein level. The C-index of the model for predicting preterm birth before 28 weeks was 0.87 (95% CI: 0.82-0.93) in the derivation cohort and 0.82 (95% CI: 0.71-0.92) in the independent validation cohort; The C-index of the model for predicting gestational latency was 0.70 (95% CI: 0.66-0.75) and 0.78 (95% CI: 0.71-0.84), respectively. In the derivation set, the areas under the curves were 0.84, 0.81, and 0.84 for predicting 1-, 3- and 5-week pregnancy prolongation, respectively. The corresponding values for the external validation were 0.78, 0.78, and 0.79, respectively. Calibration curves showed a good homogeneity between the observed and predicted ongoing pregnant probabilities. Decision curve analyses revealed satisfactory clinical usefulness. CONCLUSIONS: These novel models provide reliable and valuable prognostic predictions for patients undergoing emergency cerclage. The models can assist clinicians and patients in making personalized clinical decisions before opting for the cervical cerclage.

Pregnancy outcomes in pregnant women taking oral probiotic undergoing cerclage compared to placebo: two blinded randomized controlled trial.

AIM: The purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo. METHODS: This study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by "block" randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute). RESULTS: Results show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn's weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth. CONCLUSION: Our result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.

Use of uterine electromyography in the prediction of preterm birth after transvaginal cervical cerclage.

BACKGROUND: Preterm birth (PTB), complications of which account for approximately 35% of deaths among neonates, remains a crucial issue. Cervical insufficiency (CI) is defined as the inability of the utrine cervix to retain a pregnancy, leading to PTB. Cervical cerclage is an efficient surgery for CI patients by preventing the cervix from being further mechanically shortened. Unfortunately, a certain number of patients who had cerclage still delivered prematurely, raising the urgent need to accurately assess the risk of PTB in patients with cerclage. Uterine electromyography (uEMG) is an emerging technology that characterizes uterine contractions by describing the actual evolution process of uterine activity and has been used to predict PTB in recent years. METHOD: In this single-center retrospective case-control study, singleton pregnancy women who received cervical cerclage and uEMG assessment between January 2018 and January 2022 at the Sun Yat-sen Memorial Hospital of Sun Yat-sen University were enrolled. RESULTS: 32 PTBs were observed of the 69 women who underwent assessment. Based on multivariate logistic regression analysis, PTB after cerclage was significantly associated with previous PTB history or mid-trimester pregnancy loss (OR: 2.87, 95%CI: 1.49-5.54) and contraction frequency detected by uEMG (OR: 2.24, 95%CI: 1.44-3.49). The AUC of contraction frequency (0.766, P<0.001) was observed, and the optimal cut-off value suggested by Youden Index was 1.75 times per hour. Combined with previous preterm history and cervical length, the AUC of contraction frequency reached 0.858. After stratification by contraction frequency, the median duration was 11 weeks in the high frequency group (> 1.75 times per hour) and 15 weeks in the low frequency group (≤ 1.75 times per hour) (P<0.001). CONCLUSIONS: The uEMG effectively predicts PTB after transvaginal cervical cerclage and provides a new method for clinicians to evaluate the pregnancy outcome of CI patients.

Effectiveness and pregnancy outcomes of ultrasound-indicated and physical examination-indicated cervical cerclage: a retrospective study from a single centre.

OBJECTIVE: Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality worldwide, and cervical incompetence (CIC) is a significant contribution. Cervical cerclage (CC) is an effective obstetric intervention. However, many clinical factors affect the success rate of surgery. The objective was to investigate and compare the pregnancy and neonatal outcomes of patients who underwent ultrasound- and physical examination-indicated cervical cerclage and to explore the influencing factors of preterm delivery before 34 weeks. METHODS: The sociodemographic characteristics and clinical data of patients with a diagnosis of cervical incompetence who underwent ultrasound- and physical examination-indicated transvaginal cervical cerclage at Nanjing Maternal and Child Health Hospital from January 2020 to December 2022 were retrospectively analyzed. The pregnancy and neonatal outcomes of the patients were evaluated. Continuous variables were compared using Student's t test (for normally distributed data) or the Mann-Whitney U test (for nonnormally distributed data). Categorical variables were analysed using the chi-square test or Fisher's exact test. Additionally, logistic regression analyses and receiver operating characteristic curves were used to evaluate the associations of inflammatory markers with maternal and neonatal outcomes. RESULTS: This study included 141 participants who underwent cervical cerclage, including 71 with ultrasound-indicated cerclage and 70 with physical examination-indicated cerclage. Compared to those in the ultrasound-indicated cerclage group, the duration from cerclage to delivery, birth weight, and APGAR score in the physical examination-indicated cerclage group were significantly lower, and the rates of delivery at < 28 weeks, < 32 weeks, < 34 weeks, and < 37 weeks of gestation and neonatal mortality were significantly higher (all P < 0.05). Compared to those in the physical ultrasound-indicated cerclage group, in the physical examination-indicated cerclage group, maternal blood inflammatory markers, such as C-reactive protein (CRP), the systemic immune-inflammation index (SII) and the systemic inflammation response index (SIRI) were significantly higher (P < 0.05). Additionally, maternal blood inflammatory markers, such as the CRP, white blood cell count, platelet to lymphocyte ratio (PLR), SII, and SIRI were significantly higher in the group with delivery before 34 weeks of gestation. Furthermore, the results demonstrated that twin pregnancy had the highest OR for preterm delivery before 34 weeks of gestation (OR = 3.829; 95% CI 1.413-10.373; P = 0.008), as well as the following: the SII level (OR = 1.001; 95% CI 1.000-1.002; P = 0.003) and CRP level (OR = 1.083; 95% CI 1.038-1.131; P = 0.022). The risk factors for preterm delivery before 34 weeks of gestation were twin gestation, an increased SII level and an increased CRP level, which had good combined predictive value. CONCLUSION: In patients with cervical insufficiency, ultrasound-indicated cervical cerclage appears to lead to better pregnancy outcomes than physical examination-indicated cerclage. Twin pregnancy and maternal blood inflammatory markers, such as the CRP level and the SII, are associated with preterm delivery before 34 weeks of gestation.

A Retrospective Study Comparing Laparoscopic Transabdominal Cerclage: Pre-Pregnancy Versus in Pregnancy With Their Reproductive Outcomes and Safety.

OBJECTIVES: To compare the efficacy of laparoscopic transabdominal cerclage (TAC) pre-pregnancy and laparoscopic TAC in pregnancy in treating cervical insufficiency. METHOD: A retrospective analytical study comparing outcomes of laparoscopic TAC pre-pregnancy with laparoscopic TAC in pregnancy. A total of 178 patients who underwent laparoscopic TAC at our hospital were enrolled in the study. In total, 122 patients underwent interval cerclage, and 56 patients underwent cerclage during pregnancy. RESULTS: A total of 178 patients who met the inclusion criteria were included in the analysis. Second-trimester abortions decreased by 50%, with an overall increase in full-term live births (32.53%) in patients undergoing laparoscopic TAC pre-pregnancy. The fetal survival rate was around 90% and 85% with laparoscopic TAC pre-pregnancy and laparoscopic TAC in pregnancy, respectively. Although the obstetric outcomes of laparoscopic TAC pre-pregnancy and in pregnancy were comparable, laparoscopic TAC pre-pregnancy was safer than laparoscopic TAC in pregnancy due to the complications associated with the procedure during pregnancy. CONCLUSIONS: Laparoscopic TAC pre-pregnancy yielded better reproductive outcomes than laparoscopic TAC in pregnancy and was associated with fewer perioperative complications.

Expectant management vs. cerclage in cases with prolapsed or visible membranes in the second trimester: is 24 weeks gestation threshold critical?

OBJECTIVES: The aim of this study was to compare the efficacy of cervical cerclage with spontaneous follow-up strategy on pregnancy duration and neonatal outcomes in women with visible or prolapsed fetal membranes. METHODS: Patients who were referred to a single tertiary care centre between 1st January 2017 and 31st December 2022 were included in this comparative, retrospective cohort study. Patients were divided into two groups, those undergoing cerclage and those followed with no-cerclage. The range of pregnancy weeks for cerclage is between 18th and 27+6 weeks. RESULTS: A total of 106 cases were reviewed and nine were excluded. Based on shared decision making, cervical cerclage was performed in 76 patients (78.3 %) and 21 patients (21.6 %) were medically treated in no-cerclage group if there was no early rupture of the fetal membranes. The gestational age at delivery was 29.8 ± 6 [median=30 (19-38)] weeks in the cerclage group and 25.8 ± 2.9 [median=25 (19-32)] weeks in the no-cerclage group (p=0.004). Pregnancy prolongation was significantly longer in the cerclage group compared to the no-cerclage group (55 ± 48.6 days [median=28 (3-138)] vs. 12 ± 17.9 days [median=9 (1-52)]; p<0.001). Take home baby rate was 58/76 (76.3 %) in cerclage group vs. 8/21 (38 %) in no-cerclage group. In the post-24 week cerclage group the absolute risk reduction for pregnancy loss was 50 % (95 % CI=21.7-78.2). CONCLUSIONS: Cervical cerclage applied before and after 24 weeks (until 27+6 weeks) increased take home baby rate in women with visible or prolapsed fetal membranes without increasing adverse maternal outcome when compared with no-cerclage group.

Prevention of preterm birth in twin-to-twin transfusion syndrome: a systematic review and network meta-analysis.

OBJECTIVES: We aimed to perform a systematic review and network meta-analysis to evaluate the preventive strategies for preterm birth in twin-to-twin transfusion syndrome. METHODS: PubMed, Embase and Cochrane Central were searched from inception to December 2023 with no filters. Additionally, the reference lists of the included studies were manually examined to identify any supplementary studies. We selected randomized controlled trials and cohorts comparing interventions to prevent preterm birth in twin pregnancies complicated by twin-to-twin transfusion syndrome. A random-effects frequentist network meta-analysis was performed using RStudio version 4.3.1. Randomized controlled trials and cohorts were assessed respectively using the Risk of Bias in Non-randomized Studies of interventions tool and Cochrane Collaboration's tool for assessing risk of bias in randomized trials. RESULTS: In this systematic review and meta-analysis, we included eight studies comprising a total of 719 patients. Compared with expectant management, cerclage stood out as the only intervention associated with an increase in the survival of at least one twin (risk ratio 1.12; 95 % confidence interval 1.01-1.23). Our subgroup analysis based on different thresholds for short cervix demonstrated a significant reduction in the risk of preterm birth before 32 weeks with ultrasound-indicated cerclage using a 15 mm criterion (risk ratio 0.65; 95 % confidence interval 0.47-0.92). CONCLUSIONS: Our study suggests the potential benefit of cerclage as a preventive strategy for preterm birth in pregnancies complicated by twin-to-twin transfusion syndrome. These findings highlight the necessity for further investigation to corroborate our results and address the optimal threshold for ultrasound-indicated cerclage.

Obstetric outcomes of transabdominal cerclage: A retrospective observational study in Japan.

OBJECTIVE: This study aimed to investigate the obstetric outcomes of transabdominal cerclage (TAC) in Japan. METHODS: Questionnaires on TAC were sent to 183 institutions performing high-quality perinatal management in Japan. As a first-step questionnaire, we asked whether TAC was performed between January 1, 2011, and December 31, 2022. In the second step of the questionnaire, the characteristics of all cases were asked from all institutions in which TAC was performed. RESULTS: The response rate for the first survey was 59% (108/183). Of the 108 institutions, 27 performed TAC (25%) in 133 pregnancies. Of these 27 institutions, 19 responded to the second survey. One hundred twenty-five pregnancies were included in this study, five of which were aborted (gestational weeks <22 weeks), and 69 babies were born after 37 gestational weeks (55%). Eighty-two open abdominal cerclages were performed at 17 institutions and 43 laparoscopic TACs at three institutions. There were no differences in the age at TAC, gestational weeks at TAC, operative time of TAC, gestational weeks at delivery, incidence rate of second-trimester loss, or preterm delivery (before 37 gestational weeks) rate between the two groups. However, blood loss during open TAC was greater than that during laparoscopic TAC. CONCLUSION: TAC is a rare surgery for cervical insufficiency in Japan. TAC may be a safe and useful method for preventing second-trimester loss and preterm delivery in high-risk patients. TAC may also be a key option in Japan to improve perinatal outcomes in patients with cervical insufficiency.

Surgical Tips for Robotic Assisted Laparoscopic Abdominal Cerclage: A Minimally Invasive Approach.

Preterm birth is the leading cause of perinatal and neonatal morbidity and mortality in the developed world. An important cause of preterm birth is cervical insufficiency, leading to membrane prolapse, premature rupture of membranes, and mid-trimester pregnancy loss. A cerclage can be placed vaginally or abdominally to treat cervical insufficiency. In cases of failed prior transvaginal cerclage (TVC), transabdominal cerclage (TAC) is the alternative. The procedure can be completed via laparoscopy or open approach. The suture is placed at the internal os giving greater structural support.1 In this article, we review the definition of cervical incompetence, we present the indications for TAC, we discuss the outcomes of minimally invasive TAC compared to open approach, and we review surgical tips and tricks for robotic assisted (RA) TAC placement that can be used prior to pregnancy or in early gestation. The included images delineate the surgical technique for safe placement of robotic assisted laparoscopic abdominal cerclage in the management of cervical insufficiency.

Novel Vaginal Cerclage Assisted Laparoscopic Cervico-Sacropexy Technique for Uterovaginal Prolapse.

AIM: Laparoscopic hysteropexy is a complicated procedure that requires specialized surgical skills, including precise dissection and suturing. The aim is to describe the technical considerations for performing a new, feasible, and minimally invasive technique to correct apical and concurrent apical and anterior vaginal wall defects. METHOD: A retrospective analysis was conducted on 70 consecutive women who underwent surgery for stage ≥3 uterovaginal prolapse. As a part of the technique, an anterior 2-cm long transverse incision was made at the anterior cervicovaginal junction, and the bladder was dissected through blunt and sharp dissection to the level of the isthmus. A posterior colpotomy was performed. A polypropylene tape was inserted into the cervical connective tissue, and the free arms of the tape were inserted into the peritoneum via the posterior colpotomy. Two arms of the tape were passed from the tunnel parallel and medial to a right sacrouterine fold, then fixed to the anterior longitudinal ligament via the laparoscopic route. RESULTS: The tape can be inserted into the cervix in a median of 15 min, and the laparoscopy procedure can be completed in 24 min. No mesh erosion or long-term complications occurred. At a 1-year control, there were no cases of recurrence. CONCLUSIONS: This novel cervico-sacrocolpopexy technique is a feasible and safe, minimally invasive way to correct apical or multicompartment defects, with a short operation time and an anatomical result that mimics the normal sacrouterine ligament.

Double cervical cerclage for cervical insufficiency: Case report.

Recurrent pregnancy loss devastates parents and frustrates doctors, especially when the pregnancy progresses to the second trimester. Cervical insufficiency is the most common cause of second-trimester pregnancy loss. Abdominal cerclage is the treatment option for women with failed vaginally applied cervical cerclage. We report a 33-year-old para 0 with a history of nine second-trimester pregnancy losses. She had six failed transvaginal cerclages using McDonald's procedure. A vaginal double cervical cerclage was placed in her index pregnancy. Two mersilene tape purse-string sutures were placed in the submucosal layer of the cervix; the first 1cm below and the second at the level of the internal os. Both sutures were knotted at the 12 O'Clock position on the cervix. She carried her pregnancy to almost term and delivered a healthy baby girl weighing 2.5kg. We recommend a transvaginal double cervical cerclage with mersilene tape using a modified McDonald's technique as a viable alternative to abdominal cervical cerclage. (Afr J Reprod Health 2024; 28 [6]: 117-125).

Les fausses couches récurrentes sont dévastatrices pour les parents et frustrent les médecins, surtout lorsque la grossesse progresse jusqu'au deuxième trimestre. L'insuffisance cervicale est la cause la plus fréquente de fausse couche au deuxième trimestre. Le cerclage abdominal est l'option de traitement pour les femmes dont le cerclage cervical appliqué par voie vaginale a échoué. Nous rapportons une para 0 de 33 ans avec des antécédents de neuf fausses couches au deuxième trimestre. Elle a eu six cerclages transvaginaux selon la procédure McDonald's qui ont échoué. Un double cerclage vaginal vaginal a été placé lors de sa grossesse index. Deux fils de suture en bourse en ruban de mersilène ont été placés dans la couche sous-muqueuse du col de l'utérus ; le premier 1cm en dessous et le second au niveau de l'os interne. Les deux sutures ont été nouées à la position 12 heures sur le col. Elle a mené sa grossesse presque à terme et a donné naissance à une petite fille en bonne santé pesant 2,5 kg. Nous recommandons un double cerclage cervical transvaginal avec du ruban de mersilène en utilisant une technique McDonald's modifiée comme alternative viable au cerclage cervical abdominal. (Afr J Reprod Health 2024; 28 [6]: 117-125).

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.

BACKGROUND: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage. METHODS: C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349. FINDINGS: Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]). INTERPRETATION: Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes. FUNDING: National Institute of Health Research Health Technology Assessment Programme.

Cost-effectiveness of history-indicated cerclage vs cervical length assessment for prevention of preterm birth.

BACKGROUND: Preterm birth is one of the major causes of neonatal morbidity and mortality. Preterm delivery is a large burden to our health care system, and a history of preterm birth is one of the most common risk factors for subsequent preterm birth. OBJECTIVE: We sought to examine the cost-effectiveness of the history-indicated cerclage strategy compared with the transvaginal ultrasound cervical length assessment strategy in individuals with a history of preterm birth. STUDY DESIGN: We developed a decision analysis model to compare history-indicated cerclage and cervical length assessment. The primary outcome was the net monetary benefit from a maternal and neonatal perspective of both strategies, defined as the value of an intervention with a known willingness to pay threshold for a unit of benefit. The time horizon was set to be a lifetime. Costs (in 2022 USD) included those for the cerclage, serial transvaginal ultrasounds, maternal care for admission, neonatal care, and severe disability. Probabilities, utilities, and costs were derived from the literature. A cost-effectiveness threshold was set at $100,000 per QALY (quality-adjusted life year). We first conducted 1-way sensitivity analyses with associated variables as sensitivity analyses. We then performed a probabilistic sensitivity analysis using Monte Carlo simulation with 1000 trials to test the robustness of the results in the setting of simultaneous changes in probabilities, costs, and utilities. RESULTS: In our base-case analysis, the history-indicated cerclage strategy compared to transvaginal ultrasound cervical length assessment was associated with more cost ($85,038 vs $70,155), with slightly less effectiveness from the maternal perspective (26.74 QALY vs 26.78 QALY) and from the neonatal perspective (28.91 QALY vs 29.06 QALY), and with less maternal and neonatal net monetary benefit. Therefore, the history-indicated cerclage strategy was dominated. With the 1000 trials of Monte Carlo simulation, transvaginal ultrasound cervical length assessment was the preferred strategy 84% and 88% of the time from the maternal and neonatal perspectives, respectively. CONCLUSION: The history-indicated cerclage strategy was more expensive and slightly less effective than the transvaginal ultrasound cervical length assessment strategy with a lower net monetary benefit.

McDonald versus Shirodkar cerclage technique in the prevention of preterm birth: A systematic review and meta-analysis.

BACKGROUND: Cervical cerclage has been used for decades to reduce preterm birth. The Shirodkar and McDonald cerclage are the most commonly used techniques with no current consensus on the preferred technique. OBJECTIVE: To compare the efficacy of the Shirodkar and McDonald cerclage techniques in preventing preterm birth. SEARCH STRATEGY: Studies were sourced from six electronic databases and reference lists. SELECTION CRITERIA: Studies including women with a singleton pregnancy, requiring a cervical cerclage, using either the Shirodkar or McDonald technique that ran comparative analyses between the two techniques. DATA COLLECTION AND ANALYSIS: The primary outcome was preterm birth before 37 weeks, with analyses at 28, 32, 34 and 35 weeks. Secondary data were also collected on neonatal, maternal and obstetric outcomes. MAIN RESULTS: Seventeen papers were included: 16 were retrospective cohort studies and one was a randomised controlled trial. The Shirodkar technique was significantly less likely to result in preterm birth before 37 weeks than the McDonald technique (relative risk [RR] 0.91, 95% CI 0.85-0.98). This finding was supported by a statistically significant reduction in rates of preterm birth before 35, 34 and 32 weeks, PPROM, difference in cervical length, cerclage to delivery interval, and an increase in birthweight in the Shirodkar group. No difference was seen in preterm birth rates <28 weeks, neonatal mortality, chorioamnionitis, cervical laceration or caesarean section rates. The RR for preterm birth prior to 37 weeks was no longer significant when sensitivity analyses were performed removing studies with a serious risk of bias. However, similar analyses removing studies that utilised adjunctive progesterone strengthened the primary outcome (RR 0.83, 95% CI 0.74-0.93). CONCLUSION: Shirodkar cerclage reduces the rate of preterm birth prior to 35, 34 and 32 weeks' gestation when compared with McDonald cerclage; however, the overall quality of the studies in this review is low. Further, large, well-designed randomised controlled trials are required to address this important question to optimise care for women who may benefit from cervical cerclage.

The minimally invasive approach to abdominal cerclage: indications, complications, and techniques for placement.

PURPOSE OF REVIEW: Laparoscopic abdominal cerclage placement has become the favored approach for management of refractory cervical insufficiency. There are special considerations with respect to surgical method, management of pregnancy loss, and delivery following placement. This review addresses current literature on transabdominal cerclage with a focus on up-to-date minimally invasive techniques. RECENT FINDINGS: Recent literature on abdominal cerclage has compared laparoscopic and open approaches, evaluated the effect of preconception placement on fertility, and explored the upper gestational limit for dilation and evacuation with an abdominal cerclage in situ . SUMMARY: The objective of this article is to help minimally invasive surgeons identify candidates for transabdominal cerclage placement, understand surgical risks, succeed in their laparoscopic approach, and appropriately manage patients postoperatively.

"I had given up on being a mother": a survey of 183 women's experience of transabdominal cerclage (TAC).

BACKGROUND: Transabdominal cerclage (TAC) is a relatively uncommon intervention for preventing preterm birth. This study aimed to investigate the experience of women who had undergone this procedure. METHODS: The survey was designed in collaboration with a preterm birth studies public and patient involvement (PPI) group and ethical approval was granted by KCL BDM Research Ethics Panel (LRS-19/20-13205). Members of closed Facebook group, UK TAC Support, were invited to complete an online questionnaire about their experience of TAC, and pregnancies before and after having it placed. The survey was open between December 2019 and May 2020. Open and closed questions provided both qualitative and quantitative data for analysis, which was carried out using NVivo Pro 2020 v.1.4.1 qualitative data management software and SPSS Statistics 27 (IBM). RESULTS: One hundred eighty-three participants completed the survey, having had TAC procedures carried out in 36 hospitals. Altogether, participants had experienced 287 preterm births (PTB) and late miscarriages (LM), equating to an average of 1.6 each (range 0-5), including 18 stillbirths. TAC was indicated in 123 (67%) for previous PTB and/or LM, 29 (16%) for cervical surgery and 31 (17%) for both. 151 (83%) TAC procedures were open, 32 (17%) laparoscopic. 86% (n = 157) were placed outside pregnancy. Of those placed in pregnancy, gestation at TAC ranged from 7 to 16 weeks. When comparing earliest pre- and post-TAC pregnancy gestation (excluding first trimester losses), median gestational weeks gained following TAC was 15.5 weeks (SD 6.89). Qualitative themes included: the struggle to get treatment; lack of TAC knowledge amongst clinicians; gratitude, hope and feeling protected; possible detrimental effects of TAC. CONCLUSIONS: This very high-risk group found having a TAC gave great reassurance and hope, and were very grateful to have found the care they needed. However, they often struggled to get this support, frequently due to lack of clinician awareness. This may improve following roll-out of NHS England's Saving Babies Live Care Bundle and NHS commissioning guidelines for care of women at risk of PTB.

Mersilene tape versus conventional sutures in transvaginal cervical cerclage: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to assess the effectiveness of Mersilene tape versus alternative suture types in prolonging singleton pregnancies as well as other pregnancy and neonatal outcomes, in cases of history-, ultrasound-, and exam-indicated cervical cerclage. METHODS: A systematic review was conducted to identify relevant studies comparing different suture types in cervical cerclage procedures. The primary outcome of interest was preterm birth (PTB) rate < 37, <35, < 28, and < 24 weeks. Statistical analyses were performed to determine the relationship between suture type and various outcomes. RESULTS: A total of five studies, including three randomized controlled trials (RCTs) and two retrospective studies, with a combined participation of 2325 individuals, were included. The pooled analysis indicated no significant association between suture type and PTB at less than 37 weeks of gestation (RR: 1.02, 95% CI: 0.65-1.60, p < 0.01, I2 = 74%). Women who received Mersilene tape had a higher risk of PTB at 34-37 weeks (RR: 2.62, 95% CI: 1.57-4.37, p = 0.69, I2 = 0%), but a lower risk of PTB at less than 34 weeks (RR: 0.43, 95% CI: 0.28-0.66, p = 0.66, I2 = 46%). No statistically significant differences were observed for PTB before 28 weeks (RR: 1, 95% CI: 0.65-1.53, p = 0.70, I2 = 0%), before 24 weeks (RR: 0.86, 95% CI: 0.60-1.23, p = 0.33, I2 = 0%), incidence of chorioamnionitis (RR: 0.97, 95% CI: 020-4.83, p < 0.01, I2 = 95%), neonatal intensive care unit (NICU) admission (RR: 0.79, 95% CI: 0.28-2.22, p = 0.08, I2 = 67%) and neonatal death (RR: 1.00, 95% CI: 0.42-2.35, p = 0.17, I2 = 48%). CONCLUSION: Our findings suggest that Mersilene tape does not reduce the risk of PTB before 37, 28 or 24 weeks. We observed higher risk of preterm birth between 34 and 37 weeks with Mersilene tape but lower incidence before 34 weeks, a period with higher neonatal morbidity and mortality. Due to the limited number of studies, our results and their clinical significance should be interpreted with caution.