Pregnancy Outcomes According to Cervical Cerclage Indications and Factors Affecting Pregnancy Duration and Outcomes
- Conditions
- Cervical Incompetence (Complicating Pregnancy)
- Interventions
- Procedure: transvaginal cervical cerclage by Mc Donald technique
- Registration Number
- NCT06443112
- Lead Sponsor
- Başakşehir Çam & Sakura City Hospital
- Brief Summary
This study aimed to asses predictive factors associated with successful cervical cerclage and poor pregnancy outcomes in all indications.129 pregnant women who underwent cerclage at 12-25 weeks gestation in a perinatal medical center were included. The patients were divided into three subgroups for data analysis. Groups included patients with respectively history-indicated cerclage (group 1), ultrasound-indicated cerclage (group 2), and rescue cerclage (group 3). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks.Factors associated with successful cervical cerclage and perinatal outcomes after the procedure for all three groups were analyzed. The investigators also calculated post-cerclage the cervical length cut-off value required to predict if birth could be postponed until after the 28th week of gestation in women with cervical insufficiency.
- Detailed Description
This study retrospectively reviewed data from pregnant women who underwent cerclage from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey. The local ethics committee approved the study.
All procedures followed the relevant guidelines and regulations of the institutional ethics review board and the Declaration of Helsinki.
The patients were divided into three subgroups for data analysis. Group 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester. Group 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length (CL) was \<25 mm before the 24th week of gestation in the current singleton pregnancy, or who had \<10 mm cervical length in the current singleton pregnancy without history. Group 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix. All cervical cerclage procedures were performed by a senior obstetrician using the McDonald technique with Mersilene tape or No:1 proline. The investigators collected the following data from medical records: maternal age at cervical cerclage, gravidity, parity, body mass index, history of a cervical cone biopsy, history of premature birth and cervical cerclage, procalcitonin level, C-reactive protein (CRP) level, gestational age at cerclage, pre-and post-cerclage CL, week of birth, pregnancy complications (preterm premature rupture of the membranes (PPROM), abruptio placenta, chorioamnionitis). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks. The indications and the pregnancy outcomes (miscarriage, gestational age at delivery, birth weight, prolongation of pregnancy, and rate of preterm birth before 34 weeks) of cervical cerclage were reviewed and the factors associated with successful cervical cerclage were analyzed.
Moreover, receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency (CI). Thus, the investigators extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
- Pregnants that underwent cervical cerclage between July 2021 and July 2023 with singleton pregnancies
- Pregnant women without follow-up whose post-procedure data cannot be accessed
- Multiple pregnancies
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 3 consisted of patients undergoing rescue cerclage transvaginal cervical cerclage by Mc Donald technique Group 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix. history-indicated cerclage group (group1) transvaginal cervical cerclage by Mc Donald technique Group 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester. (Group 2) patients with ultrasound-indicated cerclage transvaginal cervical cerclage by Mc Donald technique Group 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length was \<25 mm before the 24th week of gestation in the current singleton pregnancy, or who had \<10 mm cervical length in the current singleton pregnancy without history.
- Primary Outcome Measures
Name Time Method pre-cerclage and post-cerclage cervical length cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency. time from diagnosis to birth receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL (length in centimeters) cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with CI. Thus, we extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
Latency from the time of cerclage procedure to delivery time from cerclage procedure to birth Factors affecting time (time in days) elapsed from cerclage procedure to birth were evaluated
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
İstanbul Başakşehir Çam ve Sakura City Hospital
🇹🇷Istanbul, Basaksehir, Turkey