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Pregnant women with twins and a short cervical length (CL) are at greater risk of preterm birth (PTB). The comparative efficacy of cervical cerclage and cervical pessary with or without additional progesterone to prevent PTB is unknown. We aimed to assess, in women with twin pregnancies and a short CL, the effectiveness of cerclage versus pessary and the additional treatment with 400 mg vaginal progesterone versus no progesterone in preventing PTB. This multicenter, two-by-two factorial randomised trial was conducted in 2 hospitals in Ho Chi Minh City, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm at 16 to 22 gestational weeks were recruited. Between March 2019 and July 2023, we randomised 219 participants (64.4% of the planned sample size) to cerclage plus progesterone (n = 55), Arabin pessary plus progesterone (n = 56), cerclage alone (n = 54) or Arabin pessary alone (n = 54). Primary outcome was any PTB <34 weeks. Following the second interim analysis, the study was terminated due to significantly lower rates of perinatal deaths and deliveries <28 weeks in the cerclage group. The primary outcome occurred in 20 (19.8%) participants receiving cerclage versus 20 (19%) participants receiving pessary (relative risk [RR] 1.04; 95% confidence interval [CI], 0.60 to 1.8). Delivery <28 weeks occurred in 1% versus 8.6% (RR 0.12; 95% CI, 0.01 to 0.52) and perinatal death occurred in 1% versus 5.8% (RR 0.17; 95% CI, 0.05 to 0.62) in the cerclage group and the pessary group, respectively. However, PTB <24 weeks, <32 weeks, and other neonatal outcomes were not significantly different between the 2 groups. For maternal side effects, vaginal discharge was significantly less frequent in the cerclage group. In participants allocated to progesterone, PTB <34 weeks occurred in 19 (18.4%) versus 21 (20.4%) participants who did not have progesterone (RR 0.90; 95% CI, 0.52 to 1.6). In this prematurely halted study on pregnant women with twins and a CL ≤28 mm, cerclage and cervical pessary were comparably effective on PTB <34 weeks prevention. However, compared to pessary, cerclage was associated with significantly lower rates of PTB <28 weeks and perinatal mortality. ClinicalTrials.gov Registration: NCT03863613 (https://clinicaltrials.gov/study/NCT03863613).

Objectives To compare different periods of cerclage placement in preventing preterm birth in singleton pregnancies complicated by cervical incompetence. Methods This retrospective cohort study was conducted at a tertiary hospital in Shanghai, China. A total of 499 singleton pregnancies undergoing prophylactic cervical cerclage between January 1, 2021, and June 30, 2023, at Shanghai East Hospital were included in the study. Participants were classified into the early cerclage group (cerclage performed at 11 + 0 to 15 + 6 weeks of gestation) and the late cerclage group (cerclage performed at 16 + 0 to 19 + 6 weeks of gestation). Results The median gestational ages at delivery were similar between the early cerclage group and the late cerclage group (median (IQR) 38.1 (36.6–39.1) vs. 38.3 (37.1–39.0) weeks, p  = 0.568). There was no difference in preterm birth rates of < 37 (28.0%, 93/332 vs. 21.0%, 35/167, p  = 0.089), < 34 (14.8%, 49/332 vs. 11.4%, 18/167, p  = 0.218), or < 28 (6.9%, 23/332 vs. 3.0%, 5/167, p  = 0.072) weeks of gestation between the early cerclage group and the late cerclage group. The incidence rates of chorioamnionitis, premature rupture of membranes, and cesarean section were comparable between the two groups. As a primary indicator of neonatal outcomes, the survival rates of newborns at three months post-delivery were similar between the early and late cerclage groups (94.6%, 314/332 vs. 98.2%, 164/167, p  = 0.061). Birth weights of newborns in the early and late cerclage groups were not significantly different (median (IQR) 3080.0 (2652.5–3450.0) vs. 3210.0 (2600.0–3550.0) g, p  = 0.100). The incidence rate of 5-minute Apgar scores < 7 in the late cerclage group was significantly lower than that in the early cerclage group (1.8%, 3/167 vs. 6.3%, 21/332, p  = 0.026). The incidence rates of neonatal intensive care unit admission, and respiratory distress syndrome were similar between the two groups. Conclusions Our retrospective study demonstrated that the efficacy and risk of prophylactic cervical cerclage performed at 16 + 0 to 19 + 6 weeks of gestation were comparable to those of earlier cerclage performed at 11 + 0 to 15 + 6 weeks. Our study provided robust evidence supporting the safety and clinical feasibility of late cerclage in preventing preterm birth, which offers valuable insights into optimizing the cerclage period for high-risk pregnancies.

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

To evaluate the effect of vaginal cervical cerclage on uterine artery Doppler parameters and its association with small for gestational age births across different clinical indications. This prospective observational study included 140 singleton pregnancies undergoing cervical cerclage, stratified by indication: prophylactic ( n  = 39), ultrasound-based ( n  = 62), and rescue cerclage ( n  = 39). Uterine artery pulsatility index was measured preoperatively, postoperatively, and at six weeks post-procedure. Fetal growth parameters were monitored throughout pregnancy, with births below the 10th percentile classified as small for gestational age. All procedures utilized McDonald’s technique at a single tertiary center. Postoperative pulsatility index increased significantly in the prophylactic cerclage group ( p  < 0.001), but showed minimal change in the ultrasound-based and rescue groups. PI values normalized in all groups by six weeks. Small for gestational age births occurred in 7.9% overall (prophylactic 12.8%, ultrasound-based 4.8%, rescue 7.7%), with no significant difference ( p  = 0.410). Postoperative pulsatility index values above the 95th percentile were significantly more common in the prophylactic group (30.8%) than in ultrasound-based (6.5%) or rescue cerclage groups (2.6%) ( p  < 0.001). Cervical cerclage may cause early, transient uterine hemodynamic changes, particularly in women undergoing prophylactic cerclage for a history of painless mid-trimester loss. These changes typically resolve within six weeks and are not associated with adverse fetal growth outcomes, supporting an adaptive rather than pathological response. In clinical practice, transient postoperative Doppler elevations should be interpreted in light of indication and timing rather than regarded as alarming. These findings provide reassurance for clinical counseling on cerclage safety and emphasize the importance of indication-specific Doppler monitoring to guide follow-up and patient management.

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. 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. 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]). 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. National Institute of Health Research Health Technology Assessment Programme.

IntroductionCervical 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 analysisThis 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 disseminationThe 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 registrationNCT05268640.

Background Presently, cervical cerclage is regarded as a valid method to treat cervical insufficiency, which could reduce late miscarriage and spontaneous preterm birth (sPTB). Nonetheless, the safety and effectiveness of emergency cervical cerclage (ECC) as a high-risk surgery still remains debatable when the cervix has dilated or the membranes protrude into the vagina during pregnancy at 26–27 +6  weeks of gestational age (GA). Objective To estimate maternal and perinatal outcomes of ECC in singleton pregnancy at 26–27 +6  weeks of GA compared with expectant treatment. Methods In this multicenter retrospective cohort study, the study group comprised all singleton pregnancy without signs of labor or chorioamnionitis at 26–27 +6  weeks of gestation who had expectant treatment or ECC with transvaginal cervical cerclage for cervical dilation 0.5-4 cm between 1st December 2021 to 31st December 2024 at the Women’s Hospital, Zhejiang University School of Medicine, Huzhou Maternity and Child Health Care Hospital, and Quzhou Maternal and Child Health Hospital. A directed acyclic graph was applied to depict the causality structure for simplifying confounders. The pregnancy latency and GA at delivery were collected as primary outcomes. While the the rates of sPTB before 28, 30, 32, 34 and 36 weeks of GA; and neonatal outcomes (neonatal mortality; birth weight and Apgar score at 5 min > 7) were recorded as secondary outcomes. Population were also stratified into two subgroups based on cervical dilation ≥ 3 cm or < 3 cm for further analysis. Multivariable logistic regression was applied to identify risk factors associated with sPTB with forest plot as a presentation format. Results Fifty-four women underwent ECC (ECC group), while 114 were treated with expectant treatment (Control group). Demographic characteristics were similar in two groups. However, the pregnancy latency was significantly longer (66.21 vs 33.53 days, p  < 0.001) and the GA at delivery was significantly higher (36 vs 30.45 weeks, p  < 0.001) in ECC group compared with control group. The rates of sPTB at different GAs, as well as neonatal related indicators (live births only) also displayed noticeable difference between two groups ( p  < 0.001). For subgroup analysis, either cervical dilation ≥ 3cm or < 3 cm, ECC group both delineated later GA at delivery and better neonatal outcomes verse Control group ( p  < 0.05). After adjusting for confounding factors which were represented by a directed acyclic graph (DAG), there were significant differences in the GA at delivery (beta, 5.195; 95% CI, 3.818 − 8.572; p  < 0.001), pregnancy latency (beta, 34.160; 95% CI, 17.799 − 50.522; p  < 0.001), the rates of sPTB at < 28, < 30, < 32, < 34, < 36 weeks were all significantly lower than those in the control group (all p  < 0.001), and neonatal birthweight was significantly increased (beta, 1007.427; 95%CI, 715.300 − 1299.554; p  < 0.001), and the rates of 5-min Apgar > 7 was significantly higher in ECC group when compared with the control group, further indicated that ECC in singleton pregnancies with cervical dilation 0.5–4 cm in 26–27 +6  weeks of GA may prolong the GA at delivery, reduce the rate of sPTB and improve perinatal and neonatal outcomes compared with expectant management.. Unfortunately, in the ECC group, there were two cases of intraoperative rupture of membranes due to high tension of the amniotic sac, and the operation failed. Conclusion In singleton pregnant women with cervical dilation 0.5-4 cm at 26–27 +6 GA, ECC could associated with extending GA at delivery, decreasing sPTB rate, perinatal mortality compared with conservative treatment, especially for patients cervical dilation < 3 cm, as this subgroup appears to derive greater benefit.

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.

Vaginal cervical cerclage and progesterone are established treatments for prevention of pregnancy loss and prematurity. There is limited data to assess the effect of these treatments in combination. The objective of this study was to investigate the association between progesterone and no progesterone treatment on pregnancy outcomes in women at high risk of preterm birth who had received a vaginal cervical cerclage. This is a secondary post-hoc analysis of women recruited to the C-STICH randomised controlled trial, which recruited in 75 obstetric units in the UK between 2015 and 2021. In the C-STICH trial, women with a singleton pregnancy, receiving a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were randomised to cerclage with braided or monofilament suture, with a primary outcome of pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life. In this secondary analysis, the primary outcome was pregnancy loss, defined as miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life. Secondary maternal outcomes included miscarriage and previable neonatal death; stillbirth; gestational age at delivery; preterm pre labour rupture of membranes, and sepsis. Secondary neonatal outcomes included early/late neonatal death and sepsis. For each outcome, regression models were fitted adjusting for prespecified prognostic variables. From the 2,048 women recruited to C-STICH, 1943 (95%) women had a vaginal cerclage placed and available progesterone data. Of these, 834 (43%) women received progesterone and 1,109 (57%) did not receive progesterone. In women with primary outcome data available, in our predefined analysis pregnancy loss occurred in 49 (5.9%) of 832 women who received progesterone and 91 (8.3%) of 1,103 women who did not receive progesterone (adjusted* risk ratio 0.70 (95% confidence interval (CI) [0.50, 0.99]); adjusted risk difference -0.02 (95% CI [-0.04, -0.001], *adjusted for indication, obstetric history, surgical technique, and maternal age). Further exploratory analysis excluding women who had termination of pregnancy for foetal anomaly demonstrated a nonsignificant reduction in the risk of pregnancy loss. Key limitations of this study include a nonrandomised trial design and unknown confounding relating to variation in progesterone use. In women with a vaginal cervical cerclage and concomitant progesterone there appears to be an association with a reduced risk of pregnancy loss. This combination therapy may be an important opportunity to further reduce the risk of pregnancy loss in this high-risk cohort.

To compare maternal and neonatal outcomes in women with a previous history of pregnancy loss and/or preterm delivery who underwent ultrasound-indicated cerclage (UIC) or history-indicated cerclage (HIC). PubMed, Web of Science, Scopus, and Embase databases were searched for observational studies and randomized controlled trials (RCT) from inception to 30 April 2024. Eligible studies should have compared the outcomes of women with singleton pregnancies who underwent UIC or HIC. STATA version 15.0 was employed, and the analysis was done using a random effects model and unadjusted effect sizes from the included studies. Of 25 included studies (n = 3909), most (n = 18) were retrospective cohort studies. Compared to women who underwent HIC, UIC was associated with higher risk of having a preterm birth (<37 weeks of gestation) (OR 1.48, 95% CI: 1.17, 1.88; N = 15), low birth weight (<2500g) (OR 1.78, 95% CI: 1.32, 2.41; N = 6) and admission to neonatal intensive care unit (OR 1.70, 95% CI: 1.27, 2.27; N = 6,). Women with UIC also had a higher risk of chorioamnionitis (OR 2.34, 95% CI: 1.36, 4.04; N = 4). The risk of having a low APGAR score (5-minute score of less than 7), fetal death and preterm premature rupture of membrane (PPROM) was comparable among the two groups. Our results demonstrate that UIC is associated with higher risks of adverse pregnancy outcomes compared to HIC. However, our evidence emanates from observational studies and is prone to biases, particularly because the findings were unadjusted for potential confounders. More clinical trials are needed to confirm our observations. PROSPERO CRD42024544181.