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.

[Comparison of maternal-fetal outcomes between laparoscopic cervicoisthmic cerclage and McDonald cerclage in women with cervical insufficiency].

Objective: To compare the maternal and fetal outcomes of women with cervical insufficiency (CI) undergoing McDonald cerclage (MC) and laparoscopic cervicoisthmic cerclage (LCC), so as to provide evidence for the selection of cerclage methods. Methods: A retrospective trial was carried out in the First Affiliated Hospital of Sun Yat-sen University from January 2010 to December 2020. A total of 221 women who underwent the prophylactic cerclage were divided into MC group (n=54), LCC with MC history group (n=28) and LCC without MC history group (n=129) by the mode of operation and whether the pregnant women who underwent LCC had MC history. General clinical data, pregnancy complications and pregnancy outcomes were compared between the three groups. Results: (1) General clinical data: the proportion of women accepted cervical cerclage during pregnancy in MC group, LCC with MC history group and LCC without MC history group were 100.0% (54/54), 7.1% (2/28) and 27.1% (35/129), respectively (P<0.001). The indications of the three groups showed statistical significance (P=0.003), and the main indication was the history of abortion in the second and third trimester [75.9% (41/54) vs 89.3% (25/28) vs 84.5% (109/129)]. (2) Pregnancy complications: the incidence of abnormal fetal position [7.8% (4/51) vs 17.4% (4/23) vs 19.8% (24/121)], placenta accrete [5.9% (3/51) vs 13.0% (3/23) vs 11.6% (14/121)], uterine rupture [0 vs 4.3% (1/23) vs 5.8% (7/121)] in the MC group were all lower than those in LCC with MC history and LCC without MC history groups. However, there were no statistical significances (all P>0.05). Intrauterine inflammation or chorioamnionitis [15.7% (8/51) vs 0 vs 0.8% (1/121)] and premature rupture of membrane [23.5% (12/51) vs 4.3% (1/23) vs 0] were both significantly higher in MC group than those in LCC with MC history and LCC without MC history groups (all P<0.001). (3) Pregnancy outcomes: the cesarean section rate was significantly lower in MC group (41.2%, 21/51) than that in LCC with MC history group (100.0%, 23/23) and LCC without MC history group (100.0%, 121/121; P<0.001). MC group was associated with lower expenditure than LCC with MC history and LCC without MC history groups (12 169 vs 26 438 vs 27 783 yuan, P<0.001). The success rates of live birth cerclage did not differ significantly in MC (94.4%, 51/54), LCC with MC history (82.1%, 23/28) and LCC without MC history (93.8%, 121/129) groups (χ2=5.649, P=0.059). There was no significant difference in neonatal intensive care unit occupancy, neonatal birth weight and neonatal asphyxia between the three groups (all P>0.05). Conclusions: Both LCC and MC are the treatment choice for women with CI, which may get similar liver birth. However, MC has the advantages of low cesarean section rate, economical and easy operation. Therefore, MC is recommended as the first choice for CI patients, and LCC is for women with failed MC.

Cervical cerclage training: Development and assessment of a simulator.

BACKGROUND: Cervical cerclage is a mainstay intervention for the prevention of spontaneous preterm birth in high-risk women. Simulation training facilitates high-level skill transfer in a low-consequence environment, and is being integrated into obstetrics and gynecology training. OBJECTIVE: This study aimed to develop a simulator for cervical cerclage, determine its validity as a simulator, and identify parameters suitable as proxy markers for performance. STUDY DESIGN: The 3 aims of this study were achieved, namely: (1) simulator design by obstetricians and a commercial company; (2) survey of obstetricians and gynecologists across a variety of training stages to determine need for and opinion of the simulator; and (3) comparison of novice and expert groups across a variety of proxy markers for successful cerclage insertion. RESULTS: Obstetricians and gynecologists found the simulator to be similar to clinical scenarios and suitable for skill training. Novice participants stated that the use of the simulator improved their confidence (P=.016). In a comparison between 6 expert and 8 novice surgeons, there seemed to be variations across multiple measurements of cerclage placement. CONCLUSION: Simulation is an increasingly prominent training modality for surgical skills. The simulator described herein was considered suitable for training by obstetricians and gynecologists. Further work should focus on the validations of proxy markers of successful insertion, longitudinal assessment of trainees, and correlation of training outcomes with clinical outcomes.

Efficacy of ultrasound-indicated cerclage in twin pregnancies: a retrospective case-control study matched by cervical length.

BACKGROUND: Twin pregnancies with a progressively shortening cervix in the midterm pregnancy have an increasing risk for spontaneous preterm birth. Currently, there is no known effective method to prevent preterm birth among those women, and the use of an ultrasound-indicated cerclage in twin pregnancies is still controversial. OBJECTIVE: This study aimed to estimate whether a combination of ultrasound-indicated cerclage, indomethacin, and antibiotics in twin pregnancies between 18 and 26 weeks' gestation could extend the pregnancy, reduce the risk for spontaneous preterm birth, and improve perinatal and neonatal outcomes. STUDY DESIGN: A retrospective cohort study was conducted. The ultrasound-indicated cerclage group included twin pregnancies with a transvaginal cervical length <25 mm that underwent cerclage at 18 to 26 weeks of gestation in the Women's Hospital, Zhejiang University School of Medicine, from December 2015 through August 2021. Twin pregnancies in our study that underwent cerclage also received antibiotics and indomethacin. A control group of twin pregnancies that were managed expectantly were matched with the treatment group in terms of transvaginal cervical length at diagnosis (±3 mm), gestational age at presentation of diagnosis (±3 weeks), and maternal age (±5 years). An additional subanalysis was performed in which the patients were divided into 2 subgroups based on transvaginal cervical length of either <15 mm or between 15 and 24 mm. The primary outcome was gestational age at delivery. The secondary outcomes were pregnancy latency, the rate of spontaneous preterm birth at <28, <32, <34, <36 weeks' gestation, and neonatal outcomes. RESULTS: A total of 90 twin pregnancies with a transvaginal cervical length <25 mm were managed with either a cerclage (ultrasound-indicated cerclage group, n=45) or expectantly (control group, n=45). Demographic characteristics were not significantly different between the groups. When compared with the control group, the gestational age at delivery was significantly higher (33.11±3.16 vs 30.22±4.12 weeks; P=.001) and the pregnancy latency was significantly longer (72.40±22.51 vs 45.56±28.82 days; P<.001) in the ultrasound-indicated cerclage group. The rates of spontaneous preterm birth at <28, <32, <34, and <36 weeks' gestation were significantly lower in the ultrasound-indicated cerclage group than in the control group. In terms of neonatal outcomes, there were significant reductions in the overall perinatal mortality (4.4% vs 20.0%; P<.001), neonatal intensive care unit admissions (69.0% vs 92.6%; P<.001), and composite adverse neonatal outcomes (43.7% vs 64.7%; P=.010) for the ultrasound-indicated cerclage group when compared with the control group. In the subgroup of women with a transvaginal cervical length of between 15 and 24 mm (with 21 in the ultrasound-indicated cerclage group vs 21 controls), the data were adjusted for maternal age, pregestational body mass index, in vitro fertilization, operative hysteroscopy, previous cervical surgery, previous spontaneous preterm birth, white blood cell counts, C-reactive protein level, neutrophil to lymphocyte ratio, and the shortest transvaginal cervical length measured at diagnosis. In ultrasound-indicated cerclage group, gestational age at delivery was significantly higher (32.95±3.81 vs 30.24±4.01 weeks; beta, 3.34; 95% confidence interval, 0.14-6.55; P=.042), pregnancy latency was significantly prolonged (77.19±24.81 vs 48.52±29.67 days; beta, 33.81; 95% confidence interval, 12.29-55.34; P=.003), and the rates of spontaneous preterm birth <36 weeks' gestation (57.1% vs 95.2%; adjusted odds ratio, 0.03; 95% confidence interval, 0.01-0.69; P=.029) was significantly decreased, and for neonatal outcomes, there were significant reductions in neonatal intensive care unit admissions (53.7% vs 96.7%; adjusted odds ratio, 0.04; 95% confidence interval, 0.01-0.32; P=.003) and the composite adverse neonatal outcomes (39.0% vs 73.3%; adjusted odds ratio, 0.24; 95% confidence interval, 0.08-0.68; P=.008) in the ultrasound-indicated cerclage group when compared with the control group. In the subgroup of women with a transvaginal cervical length <15 mm, gestational age at delivery was higher (33.25±2.52 vs 30.00±4.33 weeks; beta, 3.96; 95% confidence interval, 1.51-6.42; P=.002), pregnancy latency was significantly prolonged (68.21±19.85 vs 42.96±28.43 days; beta, 30.11; 95% confidence interval, 12.42-47.81; P=.001), rates of spontaneous preterm birth at <32 weeks (16.7% vs 54.2%; adjusted odds ratio, 0.10; 95% confidence interval, 0.01-0.61; P=.020) and <34 weeks (54.2% vs 83.3%, adjusted odds ratio, 0.08; 95% confidence interval, 0.01-0.66; P=.019) of gestation was significantly decreased, and neonatal birthweight was significantly increased (2023.96±510.35 vs 1421.77±611.40 g; beta, 702.40; 95% confidence interval, 297.02-1107.78; P=.001) in the ultrasound-indicated cerclage group when compared with the control group. CONCLUSION: Cerclage among women with twin pregnancies with a transvaginal cervical length <25 mm may reduce the rate of spontaneous preterm birth and improve perinatal and neonatal outcomes when compared with expectant management. It is worth noting that even with a short transvaginal cervical length of 15 to 24 mm, cerclage will significantly decrease the risk of delivery at <36 weeks' gestation and prolong pregnancy latency. Among women with a short transvaginal cervical length <15 mm, cerclage will significantly decrease the risk of delivery at <32 and <34 weeks' gestation and prolong pregnancy latency.

Comparison of Pregnancy Outcomes of History-Indicated and Ultrasound-Indicated Cervical Cerclage: A Retrospective Cohort Study.

Background: Cervical cerclage is the procedure of choice for preventing preterm delivery due to cervical insufficiency. The indication for its application may be based on the woman's reproductive history, findings at ultrasound, or clinical findings on vaginal examination. Pregnancy outcomes from these indications are variable according to the available literature. Objective: To compare the effectiveness and reproductive outcomes (miscarriage, preterm birth rates, and birth weights) of McDonald's cervical cerclage after history-indicated and ultrasound-indicated cervical cerclage in pregnant women. Methods: The retrospective cohort study was conducted at Life International Hospital Awka, Nigeria and Life Specialist Hospital Nnewi, Nigeria. Pregnant women, who had a McDonald's cervical cerclage performed due to either history or ultrasound indication between January 1, 2011, and December 31, 2020, were included in the study. Women with multiple pregnancies and those with physical examination-indicated or emergency cerclages were excluded. The main outcome measures included the prevalence of cervical cerclage, miscarriage, and preterm delivery rates. Outcomes were compared between groups with the chi-square test, Fisher's exact test, or Student's t test. p value of < 0.5 was set as significant value. Results: Overall, during the study period, 5392 deliveries occurred in the study sites, of which 103 women had a history-indicated or ultrasound-indicated cervical cerclage. This resulted in a 1.91% prevalence rate for history-indicated and ultrasound-indicated cervical cerclage. Of these, 68 (66%) had history indicated, while 35 (34%) had ultrasound-indicated cerclage. There was no difference in the sociodemographic characteristics of both groups. Both groups had similar miscarriage rates: 1.18 in 1000 and 1.04 in 1000 deliveries, respectively (RR 1.160, 95% CI: 0.3824 to 3.5186, p = 0.793). There was more preterm delivery in history-indicated cerclage than ultrasound-indicated cervical cerclage (26.50% vs. 17.10%; p = 0.292), though the difference was not statistically significant. The ultrasound group had a higher average birthweight than the history group (2.67 ± 0.99 vs. 2.53 ± 0.74). However, this difference was not statistically significant. Conclusion: The effectiveness and reproductive outcomes (miscarriage, preterm birth rates, and birth weights) of pregnant women with cervical cerclage due to history-indicated and ultrasound-indicated cervical cerclage appear similar. When needed, cervical cerclage should be freely applied for cervical insufficiency, irrespective of the type of indication.

Median effective dose of ropivacaine for prophylactic cervical cerclage in Chinese women: a dose-finding study.

BACKGROUND: Although intrathecal ropivacaine has been widely used for caesarean delivery, there are limited data for the use of ropivacaine for prophylactic cervical cerclage. We sought to determine the median effective dose of intrathecal ropivacaine for prophylactic cervical cerclage in 50% of patients (ED50) and the calculated dose required for successful block in 95% of patients (ED95). METHODS: We included Chinese women scheduled for prophylactic cervical cerclage under combined spinal-epidural (CSE) anaesthesia in the first or second trimester. A predetermined dose of intrathecal isobaric ropivacaine was administered. If this determined dose achieved an effective block at a level not lower than T12, the next dose was decreased by 0.5 mg. Otherwise, the next dose was increased by 0.5 mg. The primary outcome was the ED50 of intrathecal ropivacaine. Secondary outcomes included the calculated ED95, time from CSE to the start of surgery and so on. RESULTS: Forty patients were included in the study, 23 (57.5%) of 40 received an effective block only with intrathecal ropivacaine, while 17 (42.5%) patients needed extra epidural lidocaine to achieve a successful block. The ED50 of intrathecal ropivacaine confirmed by isotonic regression was 6.9 mg (95% CI, 6.68 to 7.12 mg), and the calculated ED95 was 7.8 mg (95% CI, 7.69 to 10.05 mg). When an effective block was achieved with intrathecal ropivacaine alone, the time to resolution of the sensory and motor blocks was 90 (75-100) min and 90 (60-100) min, respectively. CONCLUSIONS: The ED50 of intrathecal ropivacaine for prophylactic cervical cerclage was 6.9 mg. Intrathecal ropivacaine (7.8 mg) is likely to produce successful anaesthesia in 95% of patients undergoing prophylactic cervical cerclage. TRIAL REGISTRATION NUMBER: ChiCTR2100051418.

Cervical pessary for preventing preterm birth in singleton pregnancies.

BACKGROUND: Preterm birth (PTB), defined as birth prior to 37 weeks of gestation, occurs in ten percent of all pregnancies. PTB is responsible for more than half of neonatal and infant mortalities and morbidities. Because cervical insufficiency is a common cause of PTB, one possible preventive strategy involves insertion of a cervical pessary to support the cervix. Several published studies have compared the use of pessary with different management options and obtained questionable results. This highlights the need for an up-to-date systematic review of the evidence. OBJECTIVES: To evaluate the benefits and harms of cervical pessary for preventing preterm birth in women with singleton pregnancies and risk factors for cervical insufficiency compared to no treatment, vaginal progesterone, cervical cerclage or bedrest. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform to 22 September 2021. We also searched the reference lists of included studies for additional records. SELECTION CRITERIA: We included published and unpublished randomised controlled trials (RCTs) comparing cervical pessary with no treatment, vaginal progesterone, cervical cerclage or bedrest for preventing PTB. We excluded quasi-randomised trials. Our primary outcome was delivery before 34 weeks' gestation. Our secondary outcomes were 1. delivery before 37 weeks' gestation, 2. maternal mortality, 3. maternal infection or inflammation, 4. preterm prelabour rupture of membranes, 5. harm to woman from the intervention, 6. maternal medications, 7. discontinuation of the intervention, 8. maternal satisfaction, 9. neonatal/paediatric care unit admission, 10. fetal/infant mortality, 11. neonatal sepsis, 12. gestational age at birth, 13. harm to offspring from the intervention 14. birthweight, 15. early neurodevelopmental morbidity, 15. late neurodevelopmental morbidity, 16. gastrointestinal morbidity and 17. respiratory morbidity. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for eligibility and risk of bias, evaluated trustworthiness based on criteria developed by the Cochrane Pregnancy and Childbirth Review Group, extracted data, checked for accuracy and assessed certainty of evidence using the GRADE approach. MAIN RESULTS: We included eight RCTs (2983 participants). We included five RCTs (1830 women) in the comparison cervical pessary versus no treatment, three RCTs (1126 pregnant women) in the comparison cervical pessary versus vaginal progesterone, and one study (13 participants) in the comparison cervical pessary versus cervical cerclage. Overall, the certainty of evidence was low to moderate due to inconsistency (statistical heterogeneity), imprecision (few events and wide 95% confidence intervals (CIs) consistent with possible benefit and harm), and risk of performance and detection bias. Cervical pessary versus no treatment Cervical pessary compared with no treatment may reduce the risk of delivery before 34 weeks (risk ratio (RR) 0.72, 95% CI 0.33 to 1.55; 5 studies, 1830 women; low-certainty evidence) or before 37 weeks (RR 0.68, 95% CI 0.44 to 1.05; 5 studies, 1830 women; low-certainty evidence). However, these results should be viewed with caution because the 95% CIs cross the line of no effect. Cervical pessary compared with no treatment probably has little or no effect on the risk of maternal infection or inflammation (RR 1.04, 95% CI 0.87 to 1.26; 2 studies, 1032 women; moderate-certainty evidence). It is unclear if cervical pessary compared with no treatment has an effect on neonatal/paediatric care unit admission (RR 0.96, 95% CI 0.58 to 1.59; 3 studies, 1332 infants; low-certainty evidence) or fetal/neonatal mortality (RR 0.93, 95% CI 0.58 to 1.48; 5 studies, 1830 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus vaginal progesterone Cervical pessary may reduce the risk of delivery before 34 weeks (RR 0.72, 95% CI 0.52 to 1.02; 3 studies, 1126 women; moderate-certainty evidence) or before 37 weeks (RR 0.89, 95% CI 0.73 to 1.09; 3 studies, 1126 women; moderate-certainty evidence), but we are uncertain of the results because the 95% CI crosses the line of no effect. The intervention probably has little or no effect on maternal infection or inflammation (RR 0.95, 95% CI 0.81 to 1.12; 2 studies, 265 women; moderate-certainty evidence). It is unclear if cervical pessary compared with vaginal progesterone has an effect on the risk of neonatal/paediatric care unit admission (RR 0.98, 95% CI 0.49 to 1.98; low-certainty evidence) or fetal/neonatal mortality (RR 1.97, 95% CI 0.50 to 7.70; 2 studies; 265 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus cervical cerclage Only one very small study of 13 pregnant women contributed data to this comparison; the results were unclear. AUTHORS' CONCLUSIONS: In women with a singleton pregnancy, cervical pessary compared with no treatment or vaginal progesterone may reduce the risk of delivery before 34 weeks or 37 weeks, although these results should be viewed with caution due to uncertainty around the effect estimates. There is insufficient evidence with regard to the effect of cervical pessary compared with cervical cerclage on PTB. Due to low certainty-evidence in many of the prespecified outcomes and non-reporting of several other outcomes of interest for this review, there is a need for further robust RCTs that use standardised terminology for maternal and offspring outcomes. Future trials should take place in a range of settings to improve generalisability of the evidence. Further research should concentrate on comparisons of cervical pessary versus cervical cerclage and bed rest. Investigation of different phenotypes of PTB may be relevant.

Ultrasound-Indicated Cerclage in Twin Pregnancies: A Cohort Study.

Background: To report the pregnancy and neonatal outcomes in patients with twin pregnancies who underwent ultrasound-indicated cerclage (UIC) and to compare them to patients with singleton pregnancies undergoing the same procedures. Methods: Patients who underwent UIC between January 2010 and December 2020 at Kangnam Sacred Heart Hospital were reviewed. We compared characteristics, pregnancy, and neonatal outcomes between patients with singleton and twin pregnancies. Results: A total of 94 women (56 singleton and 38 twin pregnancies) underwent UIC were included. The mean gestational age (GA) at cerclage and preoperative cervical length (CL) were not significantly different. Twin pregnancies were more likely to deliver at earlier median gestations than singletons (singleton, 36 + 1 weeks vs twin, 32 + 6 weeks, and p = 0.004). The frequency of preterm delivery <34 weeks in twin group was higher than in singleton group (15 (26.8%) vs 20 (52.6%) and p =0.016). However, the frequency of preterm delivery <32, <28, and <24 weeks was not significantly different between two groups. Although neonatal weights in singleton pregnancies were heavier than twin pregnancies, neonatal mortality and morbidities were not significantly different between two groups. Among various factors contributing to preterm birth, preoperative CL ≤ 15 mm was independently associated with a higher risk of preterm delivery before 34 weeks. Furthermore, pregnancy and neonatal outcomes of twin pregnancies with cervical length ≤ 15 mm are comparable with those of singleton pregnancies (GA at delivery, singleton, 35 + 1 weeks vs twin, 32 + 5 weeks, and p = 0.24; neonatal mortality, singleton, 3.4% vs twin, 4.8%, and p = 0.64). Conclusion: The pregnancy and neonatal outcomes of UIC in twin pregnancies were comparable to those in singleton pregnancies, especially when CL is ≤15 mm. UIC might be considered a safe procedure for twin pregnancies.

The acceptability of emergency cervical cerclage within a randomised controlled trial for cervical dilatation with exposed membranes at 16-27 + 6 weeks gestation: Findings from a qualitative process evaluation of the C-STICH2 pilot trial.

OBJECTIVE: C-STICH2 is a randomised controlled trial of emergency cervical cerclage (ECC) vs routine care in women who present in pregnancy with premature cervical dilatation and exposed unruptured fetal membranes. Within the proposed trial an internal pilot was performed with an embedded qualitative process evaluation (QPE) to explore the feasibility of recruitment. The QPE aimed to collect and analyse data exploring the experiences of health care professionals (HCPs) involved in recruitment, and women approached about the trial. METHODS: Semi-structured interviews (telephone or face-to-face) were held with eligible participants who had consented to participate in the QPE. Interviews were audio-recorded, transcribed, and analysed to identify main themes. Interview transcripts were analysed using qualitative thematic analysis (QTA). RESULTS: 11 women and 23 HCPs were interviewed. Three super-ordinate themes of Fluidity of Equipoise, A Complex Obstetric History, and the Influence of Gestation were identified. Within these, the five main themes which influenced trial participation were: 1) Complex decision-making processes; 2) Predicting outcomes; 3) The importance of terminology and initial RCT approach; 4) Women's understanding of the need for research in this area; 5) Changes in practice which are trial influenced. CONCLUSIONS: For both HCPs and women and their families, there was a conflation of the potential risks and outcomes of ECC with those of elective cerclage and the complexity around ECC placement was not always well understood by those with less experience and understanding of the intervention. Decision making was shown to be complex and multi-factorial for both HCPs and women. For complex trials in rare conditions with treatment uncertainty, clinical equipoise is likely to be fluid and influenced by multiple factors.

Obstetric and fetal short- and long-term outcomes of delayed-interval delivery in multiple pregnancies.

INTRODUCTION: Multiple pregnancies are at higher risk of preterm birth. However, both children do not necessarily have to be born and exposed to the morbidity of prematurity. One option is a delayed-interval delivery with reduction of morbidity and mortality for the second twin. The present case series demonstrates the feasibility and safety of this procedure including the long-term outcome of the surviving children compared to the overall outcome of premature born children at the same perinatal center. MATERIAL: Retrospective evaluation of all cases of delayed-interval deliveries in multiple pregnancies from 2003 to 2020 at the Women's and Children's Hospital of the University Hospital Ulm. RESULTS: In 17 cases, the delivery of the second twin could be delayed, on average by 36 days. Pregnancies with delivery of the first twin before 22 weeks of gestation had a longer prolongation than pregnancies with delivery of the first twin after 22 weeks (53 vs. 22 days). If a cerclage was placed after the delivery of the first twin a longer prolongation interval could be achieved (45 vs. 19 days). No severe maternal morbidity occurred, and the short- and long-term outcome of the second twin did not differ from age-matched controls. CONCLUSIONS: In multiple pregnancies with extremely preterm birth of the first twin, delivery of the second twin can in some cases be successfully postponed without serious maternal morbidity or additional fetal complications. Delivery of the first twin before 22 weeks of gestation and placement of a cerclage is associated with a longer prolongation interval.

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.

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.

Live birth rate after cervicoisthmic cerclage in patients with previous late miscarriage and/or premature delivery.

OBJECTIVE: This study assesses the effectiveness of cervicoisthmic cerclage on the live birth rate, measured before and after performing this cerclage in a series of 62 patients with a history of late miscarriage and/or premature delivery. STUDY DESIGN: All patients who underwent cervicoisthmic cerclage in one of the 3 university hospitals of the Hospices Civils de Lyon, between January 1, 2010, and April 1, 2019, and with a history of at least one late miscarriage or spontaneous premature birth, were included. Obstetrical and neonatal data for all pregnancies before and after cervicoisthmic cerclage were collected from medical records, completed by a phone call to patients in case of missing data. RESULTS: We included 62 patients with a total of 224 pregnancies before and 95 pregnancies after cervicoisthmic cerclage. Forty-one (66%) cerclages were performed vaginally, 12 (19%) by laparotomy and 9 (15%) by laparoscopy. The live birth rate among all pregnancies evolving beyond 14 weeks was 23% before and 86% after cerclage (p < 0.01). The rate of delivery beyond 32 weeks was 13% before and 81% after cerclage, with a median term of delivery of 21 weeks and 37 weeks respectively. Twenty-two (35%) patients had at least one live birth before cerclage and 43 (69%) patients after cerclage. Five (8%) postoperative complications occurred (2 grade I, 2 grade II and 1 grade III). CONCLUSION: The markedly high live birth rate when compared to before the cerclage strongly suggests a major role for the technique of cervicoisthmic cerclage in patients with a heavy obstetrical history.

Cerclage in surgically shortened uterine cervix and pregnancy outcome: A retrospective comparison between the abdominal and vaginal procedures.

BACKGROUND: Cerclage for uterine cervical incompetence can be performed by the transabdominal or transvaginal approach. Transabdominal cerclage (TAC) is indicated for women with a short cervix or a cervical laceration who are inapplicable to transvaginal cerclage (TVC). The larger the volume of tissue removed in cervical conization, the greater the rate of miscarriage or preterm delivery in the subsequent pregnancy. AIMS: The aim of this study was to compare TAC and TVC in post-cervical conization pregnancies. METHODS: A retrospective, two-group, comparative study was conducted involving subjects who underwent cervical cerclage (TAC, n = 14; TVC, n = 18) following cervical conization and who were cared for at the University of Miyazaki Hospital between 2008 and 2020. We compared study subject characteristics and outcomes between the two groups. Primary outcome was incidence of preterm labor <37 weeks of gestation between the two groups. RESULTS: The preoperative median cervical length was significantly shorter in the TAC group (20.0 mm) than in the TVC group (31.0 mm; p < 0.01). Preoperative vaginal discharge cultures positive for Gardnerella showed a tendency to be greater in the TAC group (p = 0.073). There was no significant difference in the preterm delivery rate < 37 weeks of gestation between TAC (1/14, 7.1%) and TVC (6/18, 33.3%) groups, p = 0.10. Noninferiority test using multiple regression analysis showed that TAC is not inferior to TVC regarding gestational age at delivery, even though cervical length of TAC was significantly shorter. CONCLUSION: Women who were inapplicable to TVC due to a short cervix still achieved an equivalent outcome with TAC.

Successful term pregnancy following cervical cerclage for uterine atrophy secondary to childhood radiotherapy.

Pelvic radiotherapy can lead to scarring and atrophy of reproductive organs including the uterus. This may lead to complications, such as preterm birth, during pregnancy. The mechanism by which preterm birth is associated with pelvic radiation is believed to be due to inefficient uterine stretch or a deficient cervix. We report a case of cervical shortening during the second trimester in a pregnant woman with a history of pelvic radiotherapy in childhood. Ultrasound surveillance and cervical cerclage inserted in the shortening cervix successfully prevented preterm labour in this case. Cerclage insertion led to a longer cervix and lower fibronectin. Although cervical cerclage does not influence uterine stretch, it may be able to prevent cervical dilatation and therefore prevent ascending infections and subsequent inflammatory sequelae which results in preterm labour. We recommend cervical surveillance and targeted cerclage interventions to prevent preterm labour in women with prior childhood pelvic radiotherapy.

Outcomes following Placement and Removal of Transvaginal Cerclage in at Risk Pregnancies: A Single Center Experience.

Objective: The objective of this study was to estimate the time between removal of cerclage and delivery, stratified by indication for cerclage placement (elective or non-elective). Additionally, delivery within 72 hours after cerclage removal was compared between elective and non-elective cerclage placement, as well as between ultrasound-indicated and physical examination-indicated cerclage placement. Design: A single-center retrospective cohort study. Participants/Materials, Setting, and Methods. Clinical information of 72 pregnant women who underwent transvaginal cerclage over a 4-year period was obtained. Comparisons were made between elective (history-indicated) and non-elective (ultrasound or physical examination-indicated) cerclage placement. Comparisons were also made between physical examination-indicated and ultrasound-indicated cerclage. Results: Compared to those who had a non-elective cerclage, women undergoing elective cerclage were more likely to have history of cervical treatment (44% vs. 15%, p = 0.02), and spontaneous preterm delivery (92% vs. 61%, p = 0.003). There was no difference in the rate of delivery ≤72 hours following cerclage removal between women who had elective cerclage and those who had non-elective cerclage (46% vs. 58%, p = 0.47). Women who had an elective cerclage were more likely to have elective cerclage removal ≥36 weeks (71.8% vs. 39.4%, p = 0.01), compared to those who had undergone non-elective cerclage. The rate of delivery ≤72 hours following removal of cerclage was greater in women who had a physical examination-indicated cerclage compared to women who had ultrasound-indicated cerclage (80% vs. 39%, p = 0.04). Among women who had an elective cerclage, there was no difference in the rate of delivery at ≤72 hours between those who had elective cerclage removal at 36 weeks compared to those electively removed at 37 weeks (31% vs. 58%, p = 0.30). No complications such as fetal demise, iatrogenic amniotic membrane rupture, hemorrhage, or cervical laceration were reported within this cohort. Conclusion: Cerclage indication should be considered prior to scheduling elective cerclage removal. Women who had an elective cerclage are most likely to get it electively removed at 36 weeks compared to their counterparts who had a non-elective cerclage. Furthermore, women who had a physical examination-indicated cerclage are most likely to deliver within 72 hours of cerclage removal.

Management of an incompetent mid-second (mid-2nd) trimester absent ecto-cervix: a case series. Cervical amplification pre-cerclage insertion.

BACKGROUND: Cervical cerclage is a treatment for an incompetent cervix, the latter being a contributor to spontaneous preterm birth. There is significant difficulty with a transvaginal cerclage insertion for the absent vaginal or ecto-cervix in the mid-2nd trimester period resulting in a higher risk of late miscarriages, extremely preterm labour with increased neonatal morbidity and mortality. METHODS: A retrospective review of 5 consecutive cases managed by a surgical technique-modified high vaginal cerclage insertion at 18-20 weeks-and adjunct protocols which included vaginal progesterone use, serial infection screening and lifestyle advice, over a 12-month period ending in August 2021, is presented. Inclusion criteria included minimal or absent ecto-cervix, singleton pregnancies with an incompetent cervix attending for a vaginal cerclage whilst exclusion criteria were the usual contraindications to a cerclage insertion. Primary outcome was delivery after 34 weeks whilst seconday outcomes included maternal hemorrhage, bowel/bladder injury, chorioamnionitis and neonatal admission. RESULTS: A increased gestational latency of 13 gestational weeks (range 12-18). Mean gestational age at delivery was 36 weeks +1 (253 days) with a range of 241-264 days. Delivery after 34 weeks gestational age was 100% with no maternal surgical complications and corresponding neonatal outcomes. CONCLUSION: There is a potential therapeutic benefit of this technique and adjunct management, in managing an incompetent mid-2nd trimester absent ecto-cervix.