Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (NCT07372495) | Clinical Trial Compass
RecruitingNot Applicable
Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix
Vietnam260 participantsStarted 2026-04-10
Plain-language summary
This study aims to compare the effectiveness of cervical cerclage combined with progesterone versus progesterone alone in preventing preterm birth among women with twin pregnancies and a short cervix (cervical length ≤ 30 mm). Participants will be randomly allocated to either the intervention group (cerclage plus progesterone) or the control group (progesterone alone).
Who can participate
Age range18 Years
SexFEMALE
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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 …)
What they're measuring
1
Preterm birth < 28 weeks
Timeframe: From randomization until 27 6/7 weeks
Trial details
NCT IDNCT07372495
SponsorNational Hospital of Obstetrics and Gynecology