Favorable surgical and obstetrical outcomes in pre- and postconceptional laparoscopic abdominal cerclage: a large multicenter cohort study.

BACKGROUND: Cervical incompetence is an important cause of extremely preterm delivery. Without specialized treatment, cervical incompetence has a 30% chance of recurrence in a subsequent pregnancy. Recently, the first randomized controlled trial showed significant superiority of abdominal cerclage compared with both high and low vaginal cerclage in preventing preterm delivery at <32 weeks of gestation and fetal loss in patients with a previous failed vaginal cerclage. OBJECTIVE: This study aimed to assess surgical and obstetrical outcomes in patients with pre- and postconceptional laparoscopic abdominal cerclage placement. Furthermore, it also aimed to perform subgroup analysis based on the indication for cerclage placement in order to identify patients who benefit the most from an abdominal cerclage. STUDY DESIGN: A retrospective multicenter cohort study with consecutive inclusion of all eligible patients from 1997 onward in the Dutch cohort (104 patients) and from 2007 onward in the Boston cohort (169 patients) was conducted. Eligible patients had at least 1 second- or third-trimester fetal loss due to cervical incompetence and/or a short or absent cervix after cervical surgery. This includes loop electrosurgical excision procedure, conization, or trachelectomy. Patients were divided into the following subgroups based on the indication for cerclage placement: (1) previous failed vaginal cerclage, (2) previous cervical surgery, and (3) other indications. The third group consisted of patients with a history of multiple second- or early third-trimester fetal losses due to cervical incompetence (without a failed vaginal cerclage) and/or multiple dilation and curettage procedures. The primary outcome measure was delivery at ≥34 weeks of gestation with neonatal survival at hospital discharge. Secondary outcome measures included surgical and obstetrical outcomes, such as pregnancy rates after preconceptional surgery, obstetrical complications, and fetal survival rates. RESULTS: A total of 273 patients were included (250 in the preconceptional and 23 in the postconceptional cohort). Surgical outcomes of 273 patients were favorable, with 6 minor complications (2.2%). In the postconceptional cohort, 1 patient (0.4%) had hemorrhage of 650 mL, resulting in conversion to laparotomy. After preconceptional laparoscopic abdominal cerclage (n=250), the pregnancy rate was 74.1% (n=137) with a minimal follow-up of 12 months. Delivery at ³34 weeks of gestation occurred in 90.5% of all ongoing pregnancies. Four patients (3.3%) had a second-trimester fetal loss. The indication for cerclage in all 4 patients was a previous failed vaginal cerclage. The other subgroups showed fetal survival rates of 100% in ongoing pregnancies, with a total fetal survival rate of 96%. After postconceptional placement, 94.1% of all patients with an ongoing pregnancy delivered at ³34 weeks of gestation, with a total fetal survival rate of 100%. Thus, second-trimester fetal losses did not occur in this group. CONCLUSION: Pre- and postconceptional laparoscopic abdominal cerclage is a safe procedure with favorable obstetrical outcomes in patients with increased risk of cervical incompetence. All subgroups showed high fetal survival rates. Second-trimester fetal loss only occurred in the group of patients with a cerclage placed for the indication of previous failed vaginal cerclage, but was nevertheless rare even in this group.

Eradication of cervical canal colonization associated with prophylactic cervical cerclage: the look further study.

OBJECTIVES: The perioperative management of the cervical cerclage procedure is not unified. In general population controlling microbiome cervical status does not affect obstetric outcomes, but it might be beneficial in patients with cervical insufficiency. The aim of our study was to present the obstetric, neonatal and pediatric outcomes of patients undergoing the cervical cerclage placement procedure in our obstetric department using a regimen of care that includes control of the microbiological status of the cervix and elimination of the pathogens detected. MATERIAL AND METHODS: Thirty-five patients undergoing cervical cerclage in the 2nd Department of Obstetrics and Gynecology, Medical University of Warsaw, were included in the study. The procedure was performed only after receiving a negative culture from the cervical canal. RESULTS: Thirty-one (88.6%) patients delivered after the 34th and twenty-eight (80.0%) after the 37th week of gestation. The colonization of the genital tract was present in 31% of patients prior to the procedure, in 42% of patients - during the subsequent pregnancy course and in 48% of patients - before delivery. A total of 85% of patients who had miscarriage or delivered prematurely had abnormal cervical cultures. In patients with normal cervical cultures, and 91.7% of women delivered at term. No abnormalities in children's development were found. CONCLUSIONS: Controlling microbiological status of the cervical canal results in better or similar outcomes to those reported by other authors in terms of obstetric and neonatal outcomes. Active eradication of the reproductive tract colonization potentially increases the effectiveness of the cervical cerclage placement.

Protruding vs. visible prolapsed fetal membranes adversely affects the outcome of cervical insufficiency.

OBJECTIVE: This study aimed to determine how prolapsed fetal membranes (PFM) affect perinatal outcomes in cases of cervical insufficiency undergoing emergency cerclage or expectant management. PATIENTS AND METHODS: This retrospective study analyzed perinatal outcomes in 100 pregnant women with cervical insufficiency, including those with visible PFM at the cervical external os and those with protruding PFM to the vagina. The participants were subjected to either expectant management involving prescribed bedrest or emergency cerclage. RESULTS: In the study population, 41 (41%) preferred bedrest, while 59 (59%) chose emergency cerclage. Among those managed expectantly, 10 (10%) had visible PFM, and 31 (31%) had protruding PFM. Among those who underwent emergency cerclage, 32 (32%) had visible PFM, and 27 (27%) had protruding PFM. Delivery after 32 weeks of gestation showed similar rates between women with visible and protruding PFM, regardless of the management approach chosen. These rates were significantly higher compared to those with protruding PFM managed with bed rest and emergency cerclage. Prolongation of pregnancy in protruding-cerclage and protruding-bedrest groups was 42.3±34 and 17.9±22 days, respectively. CONCLUSIONS: Our findings provide support for considering emergency cerclage as a viable option when addressing cases involving a visible form of PFM, although the recommendation is somewhat less robust in instances of protruding PFM. The implementation of an emergency cerclage procedure has the potential to extend the time frame between diagnosis and delivery, enhance neonatal survival rates, and increase the likelihood of births occurring after 28 weeks of gestation. However, it does not seem to significantly affect the rate of births taking place after 32 weeks of gestation. This could potentially lead to complications associated with premature births and extended stays in the postnatal neonatal intensive care unit. Therefore, it is crucial to offer families detailed information regarding the pros and cons of emergency cerclage.

Emergency cerclage using double-level versus single-level suture in the management of cervical insufficiency (Cervical Occlusion double-level Stitch Application, COSA): study protocol for a multicentre, non-blinded, randomised controlled trial.

INTRODUCTION: Cervical insufficiency accounts for 15% of recurrent pregnancy losses between 16 and 28 weeks of gestation. The aim of the study is to verify the effectiveness of emergency double-level cerclage with vaginal progesterone in cervical insufficiency treatment in terms of the prevention of preterm delivery before 34 weeks of gestation. METHODS AND ANALYSIS: This trial is a multicentre, non-blinded, randomised study with 1:1 allocation ratio. The study is conducted at tertiary perinatal care departments in Poland. It will include patients with cervical insufficiency with the fetal membranes visible in the open cervical canal or protruding into the vagina between 16+0 and 23+6 weeks of pregnancy. They will be randomised into two arms: emergency single-level cerclage with vaginal progesterone or double-level cerclage with vaginal progesterone. All will be administered antibiotics and indomethacin. The primary outcome is the rate of deliveries below 34+0 weeks of gestation, while secondary outcomes include gestational age at delivery, neonatal outcomes, maternal outcomes according to the Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth and cerclage procedure complications. The planned number of participants according to the power analysis is 78. ETHICS AND DISSEMINATION: The study protocol was written in accordance with the Standard Protocol Items: Recommendations for Interventional Trials statement. It was created according to the requirements of the Declaration of Helsinki for Medical Research involving Human Subject. Ethical approval was obtained from the Ethics Committee of the Centre of Postgraduate Medical Education (no. 1/2022). The study protocol was approved and published by ClinicalTrials.gov (posted on 24 February 2022). All participants gave a written informed consent. After completion of the study its results will be published in a peer-reviewed English language journal. TRIAL REGISTRATION: NCT05268640.

Physical examination-indicated cerclage in twin pregnancies compared with singleton pregnancies.

OBJECTIVE: The aim of this study was to compare pregnancy outcomes of physical examination-indicated cerclage in twin and singleton pregnancies with bulging membranes. METHODS: All women with bulging membranes in the second trimester of pregnancy who were admitted to La Fe University and Polytechnic Hospital from January 2009 to January 2022 were included. A total of 128 participants were enrolled, 102 singleton pregnancies and 26 twin pregnancies. All patients underwent an amniocentesis to rule out intra-amniotic inflammation (IL-6 < 2.6 ng/mL). Cerclage was placed in the absence of intra-amniotic inflammation. RESULTS: Compared with singleton gestations, twin pregnancies displayed a significantly higher prevalence of nulliparity and assisted reproductive techniques. The incidence of intra-amniotic inflammation/infection was similar in both groups (68.62% in singleton vs. 65.38% in twin pregnancies). The average gestational age of delivery without cerclage in singleton gestations was 23.83 weeks (95% CI 22.82-24.84) and in twin pregnancies, it was 23.69 weeks (95% CI 21.8-25.57). The average gestational age at delivery among patients with cerclage was 37.27 weeks (95% CI 35.35-39.19) in singleton gestations and 36 weeks (95% CI 33.51-38.63) in twin pregnancies, with no significant differences. Time from diagnosis to delivery in patients with IL-6 < 2.6 ng/mL was 79.88 days, and in those with IL > 2.6 ng/mL was 10.87 days. Gestational age at delivery was significantly higher in both singleton and twin pregnancies with cerclage, compared with those without cerclage (log-rank p < .001). CONCLUSIONS: Singleton and twin pregnancies with bulging membranes behave similarly when cerclage is placed in the absence of intraamniotic inflammation/infection.

The efficacy of emergency cervical cerclage in singleton and twin pregnancies: a systematic review with meta-analysis.

OBJECTIVE: An emergency (rescue) cervical cerclage can be offered to pregnant women presenting with dilatation and prolapsed membranes in the second trimester of pregnancy because of cervical insufficiency. This study aimed to investigate the effectiveness of an emergency cerclage in both singleton and twin pregnancies in the prevention of extreme premature birth. DATA SOURCES: We performed a systematic literature search in PubMed and Embase from inception to June 2022 for transvaginal cervical emergency cerclages. STUDY ELIGIBILITY CRITERIA: All studies on transvaginal cervical emergency cerclages with at least 5 patients and reporting survival were included. METHODS: Included studies were assessed for quality and risk of bias with an adjusted Quality In Prognosis Studies tool. Random-effects meta-analyses and meta-regressions were performed for the primary outcome: survival. RESULTS: Our search yielded 96 studies, incorporating 3239 women, including 14 studies with an expectant management control group, incorporating 746 women. Overall survival after cervical emergency cerclage was 74%, with a fetal survival of 88% and neonatal survival of 90%. Singleton and twin pregnancies showed similar survival, with a pregnancy prolongation of 52 and 37 days and a gestational age at delivery of 30 and 28 weeks, respectively. Meta-regression analyses indicated a significant inverse association between mean gestational age at diagnosis and pregnancy prolongation and no association between dilatation or gestational age at diagnosis and gestational age at delivery. Compared with expectant management, emergency cerclage significantly increased overall survival by 43%, fetal survival by 17% and neonatal survival by 22%, along with a significant pregnancy prolongation of 37 days and reduction in delivery at <28 weeks of gestation of 55%. These effects were more profound in singleton pregnancies than in twin pregnancies. CONCLUSION: This systematic review indicates that, in pregnancies threatened by extreme premature birth because of cervical insufficiency, emergency cerclage leads to significantly higher survival, accompanied by significant pregnancy prolongation and reduction in delivery at <28 weeks of gestation, compared with expectant management. The mean gestational age at delivery was 30 weeks, independent of dilatation or gestational age at diagnosis. Survival was similar for singleton and twin pregnancies, implying that emergency cerclage should be considered in both.

Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data.

OBJECTIVE: This study aimed to determine whether cervical cerclage for a transvaginal ultrasound-detected short cervical length after 24 weeks of gestation in singleton pregnancies reduces the risk for preterm birth. DATA SOURCES: Ovid MEDLINE, Scopus, and the Cochrane Central Register of Controlled Trials were searched using the following terms: "cerclage, cervical," "uterine cervical incompetence," "obstetrical surgical procedures," "cervix uteri," "randomized controlled trial," and "controlled clinical trial." STUDY ELIGIBILITY CRITERIA: All randomized controlled trials comparing cerclage placement with no cerclage in singleton gestations with a transvaginal ultrasound-detected short cervical length ≤25 mm between 24+0/7 and 29+6/7 weeks of gestation were eligible for inclusion. METHODS: Individual patient-level data from each trial were collected. If an eligible trial included patients with both multiple and singleton gestations with a short cervical length detected either before or after 24+0/7 weeks of gestation, only singletons who presented at or after 24+0/7 weeks were included. The primary outcome was preterm birth <37 weeks' gestation. Secondary outcomes included preterm birth <34, <32, and <28 weeks' gestation, gestational age at delivery, latency, preterm prelabor rupture of membranes, chorioamnionitis, and adverse neonatal outcomes. Individual patient-level data from each trial were analyzed using a 2-stage approach. Pooled relative risks or mean differences with 95% confidence intervals were calculated as appropriate. RESULTS: Data from the 4 eligible randomized controlled trials were included. A total of 131 singletons presented at 24+0/7 to 26+6/7 weeks of gestation and were further analyzed; there were no data on patients with a cerclage at 27+0/7 weeks' gestation or later. Of those included, 66 (50.4%) were in the cerclage group and 65 (49.6%) were in the no cerclage group. The rate of preterm birth <37 weeks' gestation was similar between patients who were randomized to the cerclage group and those who were randomized to the no cerclage group (27.3% vs 38.5%; relative risk, 0.78; 95% confidence interval, 0.37-1.28). Secondary outcomes including preterm birth <34, <32, and <28 weeks' gestation, gestational age at delivery, time interval from randomization to delivery, preterm prelabor rupture of membranes, and adverse neonatal outcomes such as low birthweight, very low birthweight, and perinatal death were similar between the 2 groups. Planned subgroup analyses revealed no statistically significant differences in the rate of preterm birth <37 weeks' gestation between the 2 groups when compared based on cervical length measurement (≤15 mm or ≤10 mm), gestational age at randomization (24+0/7 to 24+6/7 weeks or 25+0/7 to 26+6/7 weeks), or history of preterm birth. CONCLUSION: Cervical cerclage did not reduce or increase the rate of preterm birth among singleton pregnancies with a short cervical length detected after 24 weeks of gestation. Because there was a 22% nonsignificant decrease in preterm birth associated with cerclage, which is a similar amount of risk reduction often associated with ultrasound-indicated cerclage before 24 weeks' gestation, further randomized controlled trials in this patient population are warranted.

Comparison of emergency cervical cerclage and expectant treatment in cervical insufficiency in singleton pregnancy: A meta-analysis.

OBJECTIVE: To compare the therapeutic effects of emergency cervical cerclage and expectant treatment in preterm birth due to cervical insufficiency in singleton pregnancy. METHODS: A combination of subject words and free words was used to search major domestic and foreign databases. According to inclusion and exclusion criteria, 23 studies were included that met the criteria and quality evaluation and data extraction was carried out. The data were analyzed using STATA 15 and the reporting was done in reference to the list of Preferred Reporting Items for Systematic and Meta-Analyses. RESULTS: Emergency cervical cerclage was superior to expectant treatment for the primary outcome of pregnancy prolongation (WMD = 5.752, 95% CI 5.194-6.311, 22 studies, N = 1435, I2 = 97.1%, P = 0.000). Cervical cerclage was also superior to expectant treatment for the secondary outcomes of neonatal birth weight (WMD = 1051.542, 95% CI 594.107-1508.977, 9 studies, N = 609, I2 = 96.4%, P = 0.000), neonatal Apgar 1' (WMD = 2.8720, 95% CI: 2.105-3.639, 11 studies, N = 716, I2 = 99.0%, P = 0.000), number of live births (OR = 6.018, 95% CI 2.882-12.568, 10 studies, N = 724, I2 = 55.3%, P = 0.000), deliveries after 32 weeks (OR = 8.030, 95% CI 1.38-46.892, 8 studies, N = 381, I2 = 85.9%, P = 0.021). deliveries after 34 weeks (OR = 15.91, 95% CI 5.92-42.77, 9 studies, N = 560, I2 = 59.6%, P = 0.000), number of vaginal deliveries (OR = 3.24, 95% CI 1.32-7.90, 8 studies, N = 502, I2 = 69.4%, P = 0.018), and number of neonatal survivals (OR = 9.300, 95% CI 3.472-24.910, 10 studies, N = 654, I2 = 80.5%, P = 0.000). No difference between emergency cervical cerclage and expectant treatment was found in patients with chorioamnionitis (OR = 1.85, 95% CI 0.602-4.583, 4 studies, N = 296, I2 = 16.3%, P = 0.273). CONCLUSION: Before the 28th week of pregnancy, emergency cervical cerclage can significantly prolong the gestational week and improve the neonatal survival rate, compared to expectant treatment, in women with singleton pregnancies who have a dilated uterine orifice caused by cervical insufficiency.

Perioperative complications of a transvaginal cervical cerclage in singleton pregnancies: a systematic review and meta-analysis.

OBJECTIVE: Given that many studies report on a limited spectrum of adverse events of transvaginal cervical cerclage for preventing preterm birth, but are not powered to draw conclusions about its safety, the objective of this study was to conduct a systematic review with pooled risk analyses of perioperative complications and compare characteristics on the basis of indication for cerclage in singleton pregnancies. DATA SOURCES: Ovid MEDLINE, Ovid Embase, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), and the prospective trial registers ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched from inception to April 2020. STUDY ELIGIBILITY CRITERIA: All randomized controlled trials and both retrospective and prospective observational cohort studies reporting about complications in history-indicated cerclage, ultrasound-indicated cerclage, or physical examination-indicated cerclage were eligible. Studies were included if they contained original data on the occurrence of adverse events during surgery or within 24 hours after surgery. METHODS: The Cochrane risk of bias tool for randomized controlled trials and the Newcastle-Ottawa scale for cohort and case-control studies were used for the critical appraisal. The pooled risk assessment was conducted using meta and metafor packages in R (studio), version 4.0.3. RESULTS: The search yielded 2328 potential studies; 3 randomized controlled trials, 3 prospective, and 38 retrospective cohort studies were included in the final analysis. Of the 4511 women with singleton gestations, 1561 (34.6%) underwent history-indicated cerclage, 1348 (29.9%) underwent ultrasound-indicated cerclage, and 1549 (33.3%) underwent physical examination-indicated cerclage. Most perioperative complications occurred in physical examination-indicated cerclage, especially hemorrhage (2.3%; 95% confidence interval, 0.0-7.6) and preterm premature rupture of membranes (2.5%; 95% confidence interval, 0.91-4.5). The fewest complications occurred in history-indicated cerclage, varying from 0.0% of preterm premature rupture of membranes (95% confidence interval, 0.0-1.7) to 0.9% of hemorrhage (95% confidence interval, 0.0-7.9). In ultrasound-indicated cerclage, the most common complication was hemorrhage (1.4%; 95% confidence interval, 0.0-4.1), followed by lacerations (0.6%; 95% confidence interval, 0.0-3.1) and preterm premature rupture of membranes (0.3%; 95% confidence interval, 0.0-0.8). CONCLUSION: The highest risk of perioperative complications was observed in physical examination-indicated cerclage in comparison with ultrasound- and history-indicated cerclage. However, the occurrence of complications is poorly documented in the published literature, as is the timing of the complications (ie, perioperative or later in pregnancy). There is an urgent need for uniform complication reporting policy in both cohort studies and randomized controlled trials on cerclage.

The effectiveness of transabdominal cerclage placement via laparoscopy or laparotomy: a systematic review and meta-analysis.

OBJECTIVE: Failure or technical impossibility to place a prophylactic transvaginal cerclage in women with cervical insufficiency justifies the need for an abdominal cerclage. In this systematic review and meta-analysis, we studied the obstetrical and surgical outcomes of laparoscopic and open laparotomy abdominal cerclage approaches performed before (interval) or during pregnancy. DATA SOURCES: We performed a systematic literature search in PubMed, Embase, and the Cochrane Library for studies on laparoscopic and open laparotomy abdominal cerclage placement in February 2022. STUDY ELIGIBILITY CRITERIA: All studies on laparoscopic or open laparotomy placement of an abdominal cerclage with at least 2 patients that reported on our primary outcomes were included. METHODS: All included studies were assessed for quality and risk of bias with an adjusted Quality in Prognosis Study tool. Random effects meta-analyses were performed for the primary outcomes, namely fetal survival and gestational age at delivery. RESULTS: Our search yielded 83 studies with a total of 3398 patients; 1869 of those underwent laparoscopic cerclage placement and 1529 underwent open laparotomy placements. No studies directly compared the 2 cerclage approaches. The survival (overall, 91.2%) and gestational age at delivery (overall, 36.6 weeks) were not statistically different between the approaches. For the procedure during pregnancy, the laparoscopic group showed significantly less blood loss >400 mL (0% vs 3%), a slightly lower procedure-related fetal loss (0% vs 1%), a shorter hospital stay but a longer operation duration than the open laparotomy group. For the interval cerclages, the laparoscopic group showed significantly fewer wound infections (0% vs 3%) and a shorter hospital stay than the open laparotomy group, but showed comparable offspring preterm birth and survival rates. CONCLUSION: Based on indirect comparisons, the laparoscopic and open laparotomy abdominal cerclage placements at interval or during pregnancy produced similar outcomes in terms of survival and gestational age at delivery. There are some small differences in perioperative care, surgical complications, interventions, and complications during pregnancy. This implies that both methods of abdominal cerclage placement have high success rates and thus we cannot conclude that one of the methods is superior for the placement of an abdominal cerclage.

Comparison of transvaginal cervical cerclage versus laparoscopic abdominal cervical cerclage in cervical insufficiency: a retrospective study from a single centre.

BACKGROUND: Cervical cerclage has been proposed as an effective treatment for cervical insufficiency, but there has been controversy regarding the surgical options of cervical cerclage in singleton and twin pregnancies. This study aimed to compare the pregnancy outcomes between transvaginal cervical cerclage (TVC) and laparoscopic abdominal cervical cerclage (LAC) in patients with cervical insufficiency. We also aimed to evaluate the efficacy and safety, and provide more evidence to support the application of cervical cerclage in twin pregnancies. METHODS: A retrospective study was carried out from January 2015 to December 2021. The primary outcomes were the incidence of spontaneous preterm birth (sPTB) < 24 weeks, < 28, < 32, < 34 weeks, and < 37weeks, gestational age at delivery, and the incidence of admission for threatened abortion or preterm birth after cervical cerclage. The secondary outcomes included admission to the Neonatal Intensive Care Unit, adverse neonatal outcomes and neonatal death. We also analysed the pregnancy outcomes of twin pregnancies after cervical cerclage. RESULTS: A total of 289 patients were identified as eligible for inclusion. The LAC group (n = 56) had a very low incidence of sPTB ˂ 34 weeks, and it was associated with a significant decrease in sPTB < 28 weeks, ˂32 weeks, ˂34 and < 37 weeks, and admission to the hospital during pregnancy for threatened abortion or preterm birth after cervical cerclage (0 vs.27%; 1.8% vs. 40.3%; 7.1% vs. 46.8%; 14% vs. 63.5%, 8.9% vs. 62.2%, respectively; P < 0.001), and high in gestational age at delivery compared with the TVC group (n = 233) (38.3 weeks vs.34.4 weeks,P < 0.001). Neonatal outcomes in the LAC group were significantly better than those in the TVC group. The mean gestational age at delivery was 34.3 ± 1.8 weeks, with a total foetal survival rate of 100% without serious neonatal complications in twin pregnancies with LAC. CONCLUSION: In patients with cervical insufficiency, LAC appears to have better pregnancy outcomes than TVC. For some patients, LAC is a recommended option and may be selected as the first choice. Even in twin pregnancies, cervical cerclage can improve pregnancy outcomes with a longer latency period, especially in the LAC group.

Abnormal vaginal flora and spontaneous preterm birth in high-risk singleton pregnancies with cervical cerclage.

OBJECTIVE: To investigate abnormal vaginal and suture-based bacterial flora for associations with spontaneous preterm birth in high-risk singleton pregnancies with an ultrasound-indicated or emergency cervical cerclage. MATERIALS AND METHODS: A retrospective study of 196 singleton pregnancies with an ultrasound-indicated or emergency cerclage at the Royal Women's Hospital, Australia, from 2004 to 2018. High vaginal swabs were collected regularly between 14 and 26 weeks' gestation, including pre- and post-cerclage insertion, and sent for microscopy and culture. Cervical suture was cultured upon removal. Primary outcomes were spontaneous preterm birth <37, <34 and <30 weeks. RESULTS: 43.4% (85/196) of women delivered preterm. The acquisition and persistence of vaginal Escherichia coli following cerclage insertion were independently associated with spontaneous preterm birth <37 weeks (p = .0225, p = .0477). Escherichia coli growth from the cervical suture upon removal was associated with spontaneous preterm birth <34 weeks (p = .0458). The acquisition of vaginal mixed anaerobes post-cerclage was independently associated with spontaneous preterm birth <34 weeks (p = .0480). CONCLUSION: For singleton pregnancies with an ultrasound-indicated or emergency cerclage, the presence of vaginal or suture-based Escherichia coli following cerclage insertion yields increased risk of cerclage failure and spontaneous preterm birth.

Endoscopic transabdominal cervical cerclage replacement after recurrent late miscarriage.

Transabdominal cerclage (TAC) is a recognised treatment for recurrent spontaneous late miscarriage or preterm birth due to cervical weakness. This can be performed via an open procedure before and during pregnancy, or a laparoscopic technique preconception. Complications include cerclage failure and suture migration. We present a case highlighting these complications where laparoscopic removal of an open TAC and replacement led to two successful term deliveries. A woman in her thirties with a fibroid uterus, adenomyosis and a history of three spontaneous mid-trimester losses, had an open TAC at 13 weeks of gestation. Preterm premature rupture of the membranes occurred shortly after and at 18 weeks of gestation she underwent surgical evacuation of the uterus. Subsequent hysteroscopy confirmed migration of the cerclage through the cervical canal. We demonstrate the application of endoscopic gynaecological surgery to remove and replace the TAC with two successful term births by Caesarean section in the ensuing pregnancies.

Relationship of Amniotic Fluid Sludge and Short Cervix With a High Rate of Preterm Birth in Women After Cervical Cerclage.

OBJECTIVE: We aims to determine the relationship of amniotic fluid sludge (AFS) and/or short cervical length (CL, ≤25 mm) with a high rate of preterm birth in women after cervical cerclage. METHODS: A retrospective cohort study was conducted among singleton pregnancies after cervical cerclage between January 2018 and December 2021. A total of 296 patients who underwent transvaginal ultrasound to evaluate CL and the presence of AFS within 2 weeks after cerclage were included. Pregnancy outcome after cerclage was analyzed in accordance with the presence of AFS and CL ≤25 mm. RESULTS: In patients with cerclage, AFS was an independent risk factor for preterm birth at <28 and <36 weeks but not for preterm birth at <32 weeks, and CL ≤25 mm was an independent risk factor for preterm birth at <28, <32, and <36 weeks. The Kaplan-Meier analysis showed that the association between the presence of AFS and short gestational age at delivery was statistically significant in women with CL ≤25 mm (log rank test, P = .000). The Cox regression analysis showed that these results remained significant after adjusting for confounding factors (P = .000). The negative linear relationships between AFS and CL (R = -0.454, P < .001) also explained the outcome. CONCLUSIONS: AFS and short cervix have a direct effect on pregnancies after cerclage. Mid-trimester AFS can become a supplementary ultrasound index for detecting preterm birth after cerclage in pregnant women with a short cervix.

Do patients with a short cervix, with or without an ultrasound-indicated cerclage, have an increased risk for a small for gestational age newborn?

INTRODUCTION: Mothers with a short cervix have been shown to have increased risk of spontaneous preterm delivery (PTD) and newborn morbidity. Those who require an ultrasound-indicated cerclage experience the highest rates of morbidity. Inflammation has been linked to a short cervix, and it has been linked to pregnancies affected by small for gestational age (SGA) newborns. To date, there are no studies that have investigated an association between a short cervix, with or without an ultrasound-indicated cerclage, and a SGA newborn. METHODS: This was a case-control study examining all pregnancies with a transvaginal cervical length <25 mm found at their second trimester anatomy scan. Cases were subdivided into those who received an ultrasound-indicated cerclage (Group 1, n = 52) and those who did not (Group 2, n = 139). Controls were defined as pregnancies with a transvaginal cervical length >25 mm with no cerclage (Group 3, n = 186) whose due date was within 2 months of the case pregnancy. Each short cervix case was matched with a control from group 3 in a 1:1 ratio. The primary outcome was birthweight <10% (SGA). Unadjusted data was analyzed with simple odds ratios. A logistic regression was used to control for confounding variables and provide an adjusted odds ratios (aOR). RESULTS: The incidence of SGA among cases overall (group 1 + group 2) was 13.6% (26/191). In group 3, the SGA incidence was 4.3% (8/186). The adjusted odds ratio (aOR) for a SGA infant was significant, 2.8 (95% CI 1.2, 6.6). Subgroup analysis showed that Group 1 had an increased risk for an SGA infant [aOR 4.9 (95% CI 1.8, 13.7)], but Group 2 did not show a significant finding [aOR 2.3 (95% CI 0.9, 5.7)]. CONCLUSION: Pregnancies complicated by a short cervical length <25mm, with or without a cerclage, were associated with an increased risk for a SGA newborn. Most of this significance was due to the pregnancies which received an ultrasound-indicated cerclage for a mid-trimester short cervix.

Severe maternal morbidity associated with cerclage use in pregnancy.

OBJECTIVE: To quantify the frequency of serious maternal complications associated with cerclage use during pregnancy. STUDY DESIGN: We performed a retrospective population-based cohort study of all live births in Ohio from 2006 to 2015. Maternal sociodemographic, medical, and obstetric characteristics were compared for births in which cerclage was utilized during the pregnancy versus those without cerclage. The primary outcome for the study was a composite of adverse outcome including maternal intensive care unit (ICU) admission, blood product transfusion, uterine rupture and unplanned hysterectomy in all births. Secondary outcomes included each of the individual adverse outcomes as well as maternal hospital transfer to a tertiary facility, unplanned operation after delivery and chorioamnionitis. Each outcome was also analyzed separately in singleton and twin births. Generalized linear modeling was used to estimate the relative risk of adverse maternal outcomes associated with cerclage placement after adjustment for coexisting risk factors. RESULTS: Of the 1,428,655 singleton and twin live births in Ohio from 2006 to 2015, 4595 [0.3%] were recorded on the birth certificate as having cerclage during pregnancy. Of those, 11.7% experienced a serious adverse maternal outcome, compared to 3.7% without cerclage, adjRR 2.7 [95% CI 2.5, 3.0]. The rate of the composite maternal adverse outcome was significantly increased for pregnancies with cerclage versus those without overall, and in singleton and twin pregnancies when measured individually [all p ≤ .001]. Even after adjustment for coexisting risk factors, cerclage remained significantly associated with composite adverse outcome in each of these groups. CONCLUSIONS: Over 1 in 10 women with cerclage experience an adverse maternal outcome. Even after adjusting for gestational age at delivery and other risk factors, maternal risk for serious adverse event remains over twofold increased for pregnancies with cerclage. This information may be helpful in counseling women regarding potential maternal risk when considering neonatal benefit of cerclage in pregnancies at high risk of preterm birth.

Risk of preterm birth and neonatal outcomes after cerclage placement in triplet pregnancies.

BACKGROUND: The number of triplet pregnancies in the United States has increased significantly. Perinatal morbidity and mortality are higher in these pregnancies mainly due to higher preterm birth rates. Interventions to decrease the risk of preterm delivery in this population are needed. Evidence regarding cerclage placement in triplets is limited. We performed a population-based, retrospective cohort study to study the risk of preterm birth and neonatal outcomes after cerclage placement in triplet pregnancies. METHODS: All U.S. triplet deliveries from 2006 to 2013 with risk factors for cervical insufficiency were selected, excluding cases with indicated preterm delivery. Cases were categorized according to cerclage placement status. The risk of preterm birth and adverse neonatal outcomes were calculated using propensity score analysis, generalized linear, and logistic regression models. RESULTS: From ∼33 million deliveries, 43,000 were triplets, and 7308 fulfilled eligibility criteria. There was no difference in the gestational age at delivery between the cerclage and noncerclage groups, aOR (95% CI) = 1.0(0.9-1.0). The difference between the risk of preterm delivery at <34 weeks and <32 weeks was not statistically significant. The risk of the composite outcome of neonatal complications was higher in the cerclage compared to the noncerclage group, aOR (95% CI) = 1.5 (1.1-2.2). CONCLUSIONS: Cerclage placement in triplet pregnancies does not appear to decrease preterm birth rates and seems to increase the risk of neonatal complications.

Mid-trimester miscarriage and subsequent pregnancy outcomes: the role of cervical insufficiency in a cohort of 175 cases.

OBJECTIVE: To evaluate the causes of MTM and their impact on subsequent pregnancies. MATERIAL AND METHODS: A retrospective single-center cohort study of all pregnancies with a second-trimester pregnancy loss between 14 weeks and 21 weeks + 6 days gestation, excluding terminations of pregnancy (TOP) and in utero fetal deaths. Predefined criteria were used to allocate cases to one of 6 primary etiologic diagnoses: cervical insufficiency, chorioamnionitis, placental anomalies, fetal anomalies, iatrogenic causes, or abdominal trauma. RESULTS: Among 578 mid-trimester fetal losses, 175 were MTM, a prevalence of 5.7 per 1000 live births in the center. The suspected primary cause was cervical insufficiency in 76 cases (43.4%), chorioamnionitis in 59 (33.7%), placental anomalies or preterm premature rupture of membranes in 26 (14.8%), iatrogenic in 8 (4.6%), trauma in 3 (1.7%), and undetermined in 3 cases (1.7%). A subsequent pregnancy beyond 14 WG was recorded for 78 patients. Recurrent MTM occurred in 21.8% and preterm deliveries in 14.1% ; 13% of patients without evidence of cervical insufficiency in the index pregnancy required emergency cerclage. CONCLUSION: Cervical insufficiency was the leading cause of MTM, with a high risk of recurrent MTM or preterm birth, thus prophylactic cerclage or cervical length measurements should be considered for subsequent pregnancies.

Cerclage placement in twin pregnancies with cervical dilation: a systematic review and meta-analysis.

OBJECTIVE: Existing guidelines and studies on the benefits of cerclage in twin pregnancies with a dilated cervix have low reliability and inconsistent conclusions. New randomized control trials and cohort studies focusing on twin pregnancies with cervical insufficiency were published recently. Therefore, this meta-analysis aimed to compare outcomes of cerclage placement and expectant treatment in twin pregnancies with a dilated cervix using recent data. METHODS: We screened the PubMed, Web of Science, ClinicalTrials.gov, and Cochrane Library databases to identify randomized controlled trials and cohort studies comparing maternal and perinatal outcomes of twin pregnancies with cervical dilation, with and without cerclage placement, published until December 2020. Estimates were pooled using random-effects or fixed-effect models depending on the heterogeneity. Mean difference, 95% confidence interval, and relative risk were used to compare the outcomes. The risk of bias was assessed using the Cochrane Handbook and the Newcastle-Ottawa Scale. The meta-analyses followed the guidance of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard and the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines for systematic reviews of observational studies. RESULTS: Five studies, comprising 275 twin pregnancies, met the inclusion criteria; of those, 167 underwent cerclage and 108 were expectantly managed. Cerclage placement significantly prolonged the interval from the time of diagnosis to delivery and reduced the incidence of preterm delivery, perinatal death, and complications. The fetal outcomes improved significantly in cases managed with cerclage. CONCLUSION: Therefore, emergent cerclage is a potential option for managing twin pregnancies with cervical dilation of at least 1 cm.

Association of adherence to guidelines for cervical cerclage with perinatal outcomes and placental inflammation in women with cervical length ≥2.0 cm.

OBJECTIVES: Cerclage operation is one of the most common obstetric controversies. The aim of this study was to compare the perinatal outcomes and placental inflammation of cerclage performed adherent and non-adherent to international guidelines. MATERIAL AND METHODS: This study included all consecutive women with singleton deliveries who underwent cerclage. According to the current American College of Obstetricians and Gynecologists (ACOG) guideline, we designated our study population into two groups: the adherent-to-guideline and non-adherent groups. Each group was categorized into two groups according to cervical length (CL) at the time of cerclage (<2.0 cm vs. ≥2.0 cm). We evaluated the reasons for cerclage, maternal characteristics, perioperative variables, pregnancy and neonatal outcomes, and placental inflammatory pathology according to the criteria proposed by the Society of Pediatric Pathology. RESULTS: Among 310 women with cerclage, we excluded patients (n = 21) with indicated preterm delivery (PTD), major fetal anomaly, fetal death in-utero, and missing information for reason of cerclage. We also excluded patients who underwent physical examination-indicated cerclage (n = 53) and with missing information of CL at the time of cerclage (n = 52). A total of 184 women were eventually analyzed. In women with CL < 2.0 cm, the non-adherent group showed similar PTD (<28 weeks, <34 weeks) and neonatal composite morbidity rates compared to the adherent-to-guideline group. However, in women with CL ≥ 2.0 cm, the non-adherent group manifested significantly higher PTD (<28 weeks; 16.7% vs. 4.4%, p = 0.04, <34 weeks; 23.8% vs. 5.8%, p = 0.006) and neonatal composite morbidity (20.5% vs. 5.9%, p = 0.028) rates than the adherent-to-guideline group despite similar perioperative variables and lower PTD history rates. The non-adherent group with CL ≥ 2 cm at the time of cerclage was also associated with severe histologic chorioamnionitis (p = 0.033). CONCLUSION: Cerclage performed beyond the current guidelines in pregnant women with CL ≥ 2.0 cm may confer an additional risk of perinatal complications in association with severe placental inflammation.