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.

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies.

INTRODUCTION: Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage. METHODS AND ANALYSIS: We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at <24 weeks of gestation and an asymptomatic short cervix of ≤25 mm or cervical dilatation will be randomly allocated (1:1) to both trials on vaginal cerclage and standard treatment according to the current Dutch Society of Obstetrics and Gynaecology guideline (no cerclage). Permuted blocks sized 2 and 4 will be used to minimise the risk of disbalance. The primary outcome measure is PTB of <28 weeks. Analyses will be by intention to treat. The first trial is to demonstrate a risk reduction from 25% to 10% in the short cervix group, for which 194 patients need to be recruited. The second trial is to demonstrate a risk reduction from 80% to 35% in the dilatation group and will recruit 44 women. A cost-effectiveness analysis will be performed from a societal perspective. ETHICS AND DISSEMINATION: This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05968794.

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.

Robotic-assisted single-site abdominal cerclage in the bicornuate uterus patient with cervical insufficiency.

OBJECTIVE: To demonstrate the surgical techniques for improving safety in robotic-assisted abdominal cerclage in patients with bicornuate uteri complicated by recurrent pregnancy loss and cervical insufficiency. DESIGN: Stepwise demonstration with narrated video footage. SETTING: An academic tertiary care hospital. PATIENTS: Our patient is a 22-year-old G2P0020 with a history of recurrent pregnancy loss. During her first pregnancy, she was asymptomatic until 19 weeks and delivered because of a preterm premature rupture of membranes. A transvaginal cerclage was performed for her second pregnancy at 14 weeks, which ended at 16 weeks because of preterm premature rupture of membranes. The final magnetic resonance imaging report noted a "bicorporeal uterus with duplication of the uterine body, resulting in two markedly divergent uterine horns that are fused at the isthmus... unlike a typical didelphic uterus, a single, non septated cervix is noted, which shows normal appearances, measuring 3.8 cm in length." Given her history of a uterine anomaly and recurrent pregnancy loss in the absence of other biochemical factors, her maternal-fetal medicine specialist referred her to us as the patient strongly desired future viable pregnancies. The patient was counseled on multiple alternatives, including different methods of performing the cerclage, and ultimately decided on the robotic-assisted (Da Vinci Xi) prophylactic abdominal cerclage. INTERVENTIONS: The bicornuate uterus is a rare class IV mullerian duct anomaly caused by the impaired fusion of the mullerian ducts in the uterus, classically appearing in imaging studies as a heart-shaped uterus. This patient demographic reports a high incidence of obstetric complications. Pregnancy in such a uterus causes complications like first- and second-trimester pregnancy loss, preterm labor, low-birthweight infants, and malpresentation at delivery.1 Researchers have postulated that there is an abnormal ratio of muscle fibers to connective tissue in a congenitally abnormal cervix. During pregnancy, an inadequate uterine volume may lead to increased intrauterine pressure and stress on the lower uterine segment, which can lead to cervical incompetence.2 To address cervical incompetence, cervical cerclages are a commonly utilized procedure, as recent studies demonstrate that the incidence of term pregnancies in the group with documented cervical incompetence treated with cerclage placement increased from 26% to 63%.3 One observational study noted improved obstetrical outcomes occurred with interval placement, a cerclage placed in between pregnancies in the nongravid uterus, compared with cerclage placement between 9 and 10 weeks gestation, with the mean gestational age for delivery at 32.9 weeks and 34.5 weeks when a cerclage was placed in gravid and nongravid women, respectively.4 In addition, another retrospective study was done, which demonstrated a lower incidence of neonatal death with prophylactic cerclages.5 Operating on a nonpregnant uterus offers several benefits, including its reduced size, fewer and smaller blood vessels, and simplified handling. Moreover, there are clearly no concerns regarding the fetus. In the decision to use a robotic-assisted platform vs. laparoscopic, a systematic review showed the rates of third-trimester delivery and live birth (LB) using laparoscopy during pregnancy were found to be 70% and 70%-100%, respectively. The same review demonstrated slightly improved outcomes via the robotic route regarding gestational age at delivery (median, 37 weeks), rates of LB (90%), and third-trimester delivery (90%).6 Additional factors contributing to the preference for robotics in surgical procedures include incorporating advanced tools, which can enhance the robotic system's advantages compared with traditional laparoscopy. An invaluable tool in this context is the simultaneous utilization of Firefly mode, which employs a near-infrared camera system, achieved through injecting indocyanine green dye or integrating other light sources concurrently. The intravenous administration of indocyanine green is acknowledged widely for its safety and efficacy as a contrast agent in the evaluation of microvascular circulation and organ vascularization. This property equips surgeons with heightened precision when guiding the needle, proving especially advantageous when faced with challenges in visualizing vascular anatomy. In our specific case, we harnessed the capabilities of Firefly mode in conjunction with hysteroscopic light, enabling us to vividly illustrate the contours of a bicornuate uterus from both external and internal perspectives. We demonstrate a simplified technique of the abdominal cerclage, one cerclage around the internal cervical os of the uterus, using a robotic-assisted platform in a nongravid patient. The surgery began with the eversion of the umbilicus, and a 15-mm skin incision was made in the umbilicus. A Gelpoint mini advanced access site laparoscopy device was inserted into the incision, and CO2 was allowed to insufflate the abdominal cavity with careful attention given to intraabdominal pressure. Once the DaVinci was docked, the surgeon began the creation of a bladder flap. The bladder was carefully dissected from the lower uterine segment and both uteri using monopolar scissors. The anatomical differences of a bicornuate uterus prompted the surgeon to dissect a wider circumference for safety reasons, where a wider dissection offers a better view of the uterine vessels and ease of introducing the Mersilene tape later on. Bilateral uterine vessels were further skeletonized and exposed anteriorly using blunt dissection and monopolar scissors. After further dissection and lateralization, the final result creates a landmark medial to the right uterine vessels at the level of the internal cervical os with which the needle of the Mersilene tape will be able to pass through. The Mersilene tape was guided from anterior to posterior via a previously straightened needle. Similarly, a landmark was created on the left, and the Mersilene tape was directed from anterior to posterior. The Mersilene tape was placed circumferentially around the internal cervical os of the bicornuate uterus, medial to the uterine vessels. Both ends of the Mersilene tape were then gently pulled, ensuring that the tape was lying flat on the anterior of the internal cervical os with no bowels or uterine vessels within it. The tape was then tied posteriorly at the 6 o'clock position with appropriate tension. A 2-0 silk was then sutured to the tails of the tape using the purse-string technique to ensure that it would remain securely tied and in the correct position. Hemostasis was assured. Both a hysteroscopy and a cystoscopy were done after the completion of the cerclage to ensure that no tape or sutures were seen within the cervical canal or the uterine cavity. None were observed. MAIN OUTCOMES MEASURES: The success criteria for the surgery were identified as the patient's ability to attain a viable pregnancy after the cerclage placement, along with achieving LB. RESULTS: Subsequently, a spontaneous pregnancy was achieved. An infant weighing 3 pounds and 16 ounces was delivered by cesarean section at 36 weeks because of an oligohydramnios. The infant is currently healthy at 13 pounds. CONCLUSION: Robotic-assisted abdominal cerclage around the internal cervical os in a bicornuate uterus offers a possibly feasible and straightforward technique for surgeons seeking to reduce risks, although further research is needed.

The effectiveness of cervical cerclage in twin pregnancies with a mid-trimester short cervix: A retrospective cohort study.

OBJECTIVE: To analyze the effectiveness of cerclage in twin pregnancies with a short cervix. STUDY DESIGN: Retrospective cohort study performed in two University Institutions in Valencia (Spain) with two different protocols for the management of asymptomatic dichorionic diamniotic twin pregnancies with mid-trimester cervical length ≤ 25 mm: treatment with indomethacin, antibiotics and cerclage (cerclage group) (N = 43) versus expectant management (control group) (N = 37). RESULTS: The initial cervical length was similar in both groups but detection of a short cervix was performed earlier in the cerclage group (21.6 vs 24.1 weeks, p < 0.001). Women with cerclage had a greater pregnancy latency (12.5 vs. 7.7 weeks, p < 0.001); higher gestational age at delivery (34.1 vs. 31.8 weeks, p < 0.04); less spontaneous preterm birth (SPB) < 28 weeks (11.6 % vs 37.8 %, p < 0.009); higher birthweight (2145 vs 1733 g, p < 0.001); lower birthweight < 1500 g (12.5 % vs 40.0 %, p < 0.001); less admissions to the neonatal intensive care unit (NICU) (24.1 % vs 43.3 %, p < 0.03); shorter stay at NICU (25.6 vs 49.4 days, p < 0.02); lower respiratory distress requiring mechanical ventilation (14.9 % vs 36.5 %, p < 0.02); fewer patent ductus arteriosus (8.9 % vs 26.9 %, p < 0.008); and lower composite adverse neonatal outcome (26.6 % vs. 44.8 %, p < 0.03). Cerclage and gestational age at diagnosis were the only independent predictors of SPB < 32 and < 28 weeks by multivariate analysis. The cumulative data in the literature show promising beneficial effects of cerclage. CONCLUSION: Our data suggest that cerclage in asymptomatic twin pregnancies with a short cervix may reduce the earliest SPB and may improve neonatal outcome.

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.

Comparison of two emergency cervical cerclage techniques in twin pregnancies: A retrospective cohort study matched with cervical dilation.

OBJECTIVES: This retrospective cohort study aimed to assess the efficacy of emergency cervical cerclage (ECC) performed with the combined McDonald-Shirodkar technique in twin pregnancies between 18 and 26 weeks of pregnancy with painless cervical dilation 1 to 6 cm. METHODS: A retrospective cohort study matched with the degree of cervical dilation was conducted. The study group (case group) included women with twin pregnancies undergoing combined McDonald-Shirodkar approach with cervical dilation ≥1 cm between 18 to 26 weeks of gestation at four institutions, from December 2015 to December 2022. To minimize confounding factors, we elucidated the causality structure using a directed acyclic graph and performed 1:1 case-control matching. A control group underwent the McDonald approach. The primary outcome was gestational age (GA) at delivery. The secondary outcomes were pregnancy latency; the rates of spontaneous preterm birth at <28, <30, <32, and <34 weeks; and neonatal outcomes. Additional subanalysis was performed by dividing the patients into two subgroups of women with cervical dilation ≥3 cm and <3 cm. RESULTS: A total of 84 twin pregnancies were managed with either the combined McDonald-Shirodkar approach (case group: n = 42) or the McDonald approach (control group: n = 42). Demographic characteristics were not significantly different in the two groups (P > 0.05). After adjusting for confounders that were represented by a directed acyclic graph, median GA at delivery was significantly higher (30.5 vs 27 weeks; Bate: 3.40 [95% confidence interval (CI), 2.13-4.67], P < 0.001) and median pregnancy latency was significantly longer (56 vs 28 days; Bate: 24.04 [95% CI, 13.31-34.78], P < 0.001) in the case group compared with the control group. Rates of spontaneous preterm birth at <28, <30, <32, and <34 weeks were significantly lower in the case group than in the control group. For neonatal outcomes, there was higher birth weight (1543.75 vs 980 g; Bate: 420.08 [95% CI, 192.18-647.98], P < 0.001) and significantly lower overall perinatal mortality (7.1% vs 31%; adjusted odds ratio, 0.16 [95% CI, 0.04-0.70], P = 0.014) in the case group compared with the control group. When cervical dilation was ≥3 cm, the combined McDonald-Shirodkar procedure can significantly reduce perinatal mortality (8.3% vs 46.7%; adjusted odds ratio, 0.09 [95% CI, 0.01-0.77], P = 0.028), significantly decrease the risk of delivery at <28 and <30 weeks, and prolong GA at delivery and pregnancy latency compared with the McDonald procedure. CONCLUSIONS: ECC performed with the combined McDonald-Shirodkar procedure in women with twin pregnancies who have cervical dilation 1 to 6 cm in midtrimester pregnancy may reduce the rate of spontaneous preterm birth and improve perinatal and neonatal outcomes compared with the McDonald procedure, especially for twin pregnancies in women with cervical dilation of 3 to 6 cm and prolapsed membranes.

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.

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.

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.

Cervical Cerclage: A Comprehensive Review of Major Guidelines.

Importance: Cervical cerclage (CC) represents one of the few effective measures currently available for the prevention of preterm delivery caused by cervical insufficiency, thus contributing in the reduction of neonatal morbidity and mortality rates. Objective: The aim of this study was to review and compare the most recently published major guidelines on the indications, contraindications, techniques, and timing of placing and removal of CC. Evidence Acquisition: A descriptive review of guidelines from the American College of Obstetricians and Gynecologists (ACOG), the Royal College of Obstetricians and Gynaecologists (RCOG), the Society of Obstetricians and Gynaecologists of Canada (SOGC), and the International Federation of Gynecology and Obstetrics (FIGO) on CC was carried out. Results: There is a consensus among the reviewed guidelines regarding the recommended techniques, the indications for rescue CC, the contraindications, as well as the optimal timing of CC placement and removal. All medical societies also agree that ultrasound-indicated CC is justified in women with history of prior spontaneous PTD or mid-trimester miscarriage and a short cervical length detected on ultrasound. In addition, after CC, serial sonographic measurement of the cervical length, bed rest, and routine use of antibiotics, tocolysis, and progesterone are unanimously discouraged. In case of established preterm labor, CC should be removed, according to ACOG, RCOG, and SOGC. Furthermore, RCOG and SOGC agree on the prerequisites that should be met before attempting CC. These 2 guidelines along with FIGO recommend history-indicated CC for women with 3 or more previous preterm deliveries and/or second trimester pregnancy miscarriages, whereas the ACOG suggests the use of CC in singleton pregnancies with 1 or more previous second trimester miscarriages related to painless cervical dilation or prior CC due to painless cervical dilation in the second trimester. The role of amniocentesis in ruling out intra-amniotic infection before rescue CC remains a matter of debate. Conclusions: Cervical cerclage is an obstetric intervention used to prevent miscarriage and preterm delivery in women considered as high-risk for these common pregnancy complications. The development of universal international practice protocols for the placement of CC seems of paramount importance and will hopefully improve the outcomes of such pregnancies.

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.

"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.

Outcomes following elective cerclage versus ultrasound surveillance in women with one prior preterm event.

OBJECTIVE: Preterm birth, defined as delivery before 37 weeks' gestation, is a major obstetric challenge and is associated with serious long-term complications in those infants that survive. Preventative management includes cervical cerclage, either as an elective procedure or performed following transvaginal ultrasound surveillance and shortening of the cervix (≤25 mm). Significant questions remain regarding the optimal management, target population and technique. Therefore, this study aimed to assess differences in risk factors and pregnancy outcomes for women who received an elective cerclage versus ultrasound surveillance, following one prior premature event (spontaneous preterm birth/second trimester loss). STUDY DESIGN: Women were retrospectively identified from St Thomas's Hospital Preterm Birth Clinical Network Database. Women who had one prior premature event (between 14+0 and 36+6 weeks' gestation) were included and they were separated into those that an elective cerclage and those who underwent ultrasound surveillance to assess differences in demographics, pregnancy risk factors and preterm birth outcomes. We excluded women who received other preventative therapies. We also separately analysed those women who required an ultrasound-indicated cerclage, comparing the differences between women that delivered preterm and term. RESULTS: We collected data from 1077 women who had a prior preterm event. 66 women received an elective cerclage. 11.4% of women who had ultrasound surveillance received an ultrasound indicated cerclage. Women with a prior history of mid-trimester loss, instead of preterm birth, were more likely to receive an elective cerclage. The mean gestational age of delivery was similar between those women who received an elective cerclage and those who had ultrasound surveillance with and without an ultrasound-indicated cerclage (38+1 vs 37+1), however, preterm birth rates <37 weeks' were twice as high in this ultrasound group (OR 2.3 [1.1-4.5], p = 0.02). In those women that do require an ultrasound-indicated cerclage, 50.4% deliver preterm. CONCLUSIONS: In conclusion, this study shows that in women with one prior preterm event, both history-indicated cerclage and ultrasound surveillance are appropriate management options. The majority of women undergoing ultrasound surveillance did not require a cerclage and so avoided the potential perioperative complications of cerclage insertion. However, those that did require an ultrasound-indicated cerclage were at high risk of preterm birth so should be followed up closely to enable adequate preterm birth preparation. Further prospective studies comparing history indicated cerclage and US surveillance in women with one prior preterm event are necessary.

Characteristic impairment of progesterone response in cultured cervical fibroblasts obtained from patients with refractory cervical insufficiency.

Preterm birth (PTB) is the leading cause of neonatal mortality, and reducing the PTB rate is one of the most critical issues in perinatal medicine. Cervical insufficiency (CI), a major cause of PTB, is characterised by premature cervical ripening in the second trimester, followed by recurrent pregnancy loss. Although multiple clinical trials have suggested that progesterone inhibits cervical ripening, no studies have focused on progesterone-induced molecular signalling in CI. Here, we established a primary culture system for human uterine cervical fibroblasts using a sample of patients with refractory innate CI who underwent transabdominal cervical cerclage and patients with low Bishop scores who underwent elective caesarean section as controls. RNA sequencing showed that the progesterone response observed in the control group was impaired in the CI group. This was consistent with the finding that progesterone receptor expression was markedly downregulated in CI. Furthermore, the inhibitory effect of progesterone on lipopolysaccharide-induced inflammatory stimuli was also impaired in CI. These results suggest that abnormal cervical ripening in CI is caused by the downregulation of progesterone signalling at the receptor level, and provide a novel insight into the molecular mechanism of PTB.

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.

Management of Twin Pregnancy Complications Amid COVID-19: Posterior Colpotomy Approach for Abdominal Cerclage Removal at 18 Weeks Gestation - A Case Report.

BACKGROUND Cervical incompetence and deformities contribute significantly to mid-trimester pregnancy losses and preterm births. Abdominal cerclages prevent these complications, particularly in patients with a history of failed vaginal cerclage or severe cervical deformities. However, pregnancy complications such as chorioamnionitis and fetal demise may necessitate cerclage removal. The removal methods vary, with the least invasive being the colpotomy approach, associated with lower morbidity rates than the transabdominal approach or laparoscopy. CASE REPORT We detail a case involving a 31-year-old woman with a twin pregnancy at 18 weeks gestation, complicated by COVID-19 and chorioamnionitis. This clinical scenario necessitated the removal of an abdominal cerclage. Given the patient's risk profile, a posterior colpotomy approach was deemed most suitable. CONCLUSIONS The posterior colpotomy approach provided an effective and less risky method for abdominal cerclage removal in a high-risk patient. It successfully mitigated the potential complications of general anesthesia and operative risks associated with laparoscopy/laparotomy, offering optimal operative conditions.

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.