Cervical cerclage to prevent preterm birth in twin pregnancies
The Value of Prophylactic Cervical Cerclage Against Preterm Birth in Twin Pregnancies With History of Preterm Birth and Non-shortened Cervix: A Randomized Controlled Trial
This study is testing whether a stitch in the cervix can help women with twin pregnancies and a history of early births carry their babies to term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Sharkia) |
| Trial ID | NCT05334264 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of prophylactic cervical cerclage in preventing preterm birth among twin pregnancies that have a history of preterm births but do not show cervical shortening. The study focuses on women aged 18-50 with dichorionic twins and a cervical length of at least 25 mm during early pregnancy. By comparing outcomes between those receiving the cerclage and those who do not, the trial aims to provide insights into the potential benefits and risks of this intervention in high-risk pregnancies.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-50 with dichorionic twins and a history of one or more preterm births, who are asymptomatic and have a cervical length of at least 25 mm.
Not a fit: Patients with triplets or quadruplets, monochorionic twins, or those experiencing complications such as threatened miscarriage will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of preterm births in twin pregnancies, improving neonatal outcomes.
How similar studies have performed: While previous studies have shown mixed results regarding the efficacy of cervical cerclage in twin pregnancies, this trial aims to provide more definitive data on its protective value.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18-50 years. * Dichorionic twins. * History of ≥1 preterm birth. * Transvaginal sonographic cervical length is ≥25 mm at 14-20 weeks gestational age. * Asymptomatic. Exclusion Criteria: * Triplets and quadruplets. * Monochorionic twins. * Threatened/ inevitable miscarriage * Bulging membranes through the external os. * Extremes of age. * Major fetal anomalies. * Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis... etc. * Fetal demise. * Fetal reduction in the current pregnancy.
Where this trial is running
Zagazig, Sharkia
- Faculty of medicine, Zagazig University — Zagazig, Sharkia, Egypt (Recruiting)
Study contacts
- Principal investigator: Amro El Nemr — Zagazig University
- Study coordinator: Hytham Atia
- Email: hythamatia@gmail.com
- Phone: +966538308500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.