Cerclage plus progesterone versus progesterone alone for twins with a short cervix
Cervical Cerclage Plus Vaginal Progesterone Versus Vaginal Progesterone Alone in Twin Pregnancies With a Short Cervix for Prevention of Preterm Birth: a Randomized Controlled Trial
This will test whether adding a cervical stitch (cerclage) to progesterone helps prevent early birth in people carrying twins who have a short cervix (≤30 mm).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Hospital of Obstetrics and Gynecology Academic / other |
| Locations | 6 sites (Bac Ninh and 5 other locations) |
| Trial ID | NCT07372495 on ClinicalTrials.gov |
What this trial studies
Women with twin pregnancies between 16+0 and 24+0 weeks and a transvaginal cervical length of 30 mm or less are randomly assigned to receive either a cervical cerclage plus progesterone or progesterone alone. The trial compares rates of preterm birth and related neonatal outcomes between the two groups. Participants are screened to exclude those with major fetal anomalies, monochorionic monoamniotic gestations, twin-to-twin transfusion syndrome, cervical dilation, or active preterm labor. Follow-up includes obstetric monitoring through delivery and assessment of neonatal morbidity and mortality.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with a twin pregnancy at 16+0 to 24+0 weeks and an ultrasound-confirmed cervical length ≤30 mm, without major fetal anomalies or signs of active labor, are ideal candidates.
Not a fit: People with monochorionic monoamniotic twins, twin-to-twin transfusion syndrome, cervical dilation, active preterm labor, prior indications for cerclage, or major fetal anomalies are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, adding cerclage to progesterone could reduce preterm births in twin pregnancies with a short cervix and lower neonatal complications and NICU stays.
How similar studies have performed: Previous studies of cerclage or progesterone alone in twin pregnancies have produced mixed or limited results, so the combined approach remains relatively untested and evidence is inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal age ≥ 18 * Twin pregnancy * Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation * Gestational age at 16+0- 24+0 weeks Exclusion Criteria: A potential paticipant who meets any of the following criteria will be excluded from participation in this trial: * Women with twin pregnancy in which one or both fetuses are diagnosed with a major structural or congenital abnormality that is likely to influence the composite adverse neonatal outcome. * Women with a monochorionic monoamniotic twin pregnancy * A monochorionic twin pregnancy with twin-to-twin transfusion syndrome before or at the time of inclusion. * Patients have indications for vaginal cerclage: Recurrent late miscarriage (from 14 weeks) or preterm birth occurring two or more times. * Women with dilatation of the cervix diagnosed by ultrasound or physical exam * Women with overt symptoms of preterm labor at the time of measurement of the short cervix (regular contractions, PPROM, recurrent blood loss). * Women with the presence of fever ≥ 38 degrees Celsius. * Women with a placenta previa, vasa previa. * Uterine malformations: unicornuate uterus, bicornuate uterus, uterine septum, fibroid… * Severe maternal conditions (heart failure, chronic kidney disease, systemic lupus erythematosus …)
Where this trial is running
Bac Ninh and 5 other locations
- Bac Ninh 1 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam — Bac Ninh, Vietnam (Not_yet_recruiting)
- Bac Ninh 2 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam — Bac Ninh, Vietnam (Not_yet_recruiting)
- National Hospital of Obstetrics and Gynecology — Hanoi, Vietnam (Recruiting)
- Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam — Hung Yen, Vietnam (Not_yet_recruiting)
- Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam — Ninh Binh, Vietnam (Not_yet_recruiting)
- Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam — Quang Ninh, Vietnam (Not_yet_recruiting)
Study contacts
- Study coordinator: Thu Ha T Nguyen, Assoc. Prof
- Email: dr.hanguyen.nhog@gmail.com
- Phone: 84965995599
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.