Cerclage Plus Progesterone vs Progesterone Alone in Twin 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
National Hospital of Obstetrics and Gynecology
260 participants
Apr 10, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- Maternal age ≥ 18
- Twin pregnancy
- Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation
- Gestational age at 16+0- 24+0 weeks
Exclusion Criteria11
- 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 …)
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Interventions
Participants will receive cervical cerclage according to local protocols within one week after randomization. The procedure will be performed by two to three senior clinicians experienced in cerclage in each center, using the McDonald technique.
Vaginal micronized progesterone will be administered at a total daily dose of 400 mg, given as Utrogestan® 200 mg (Besins Healthcare, France) twice daily, in the morning and at bedtime. Participants will be asked to record their vaginal progesterone application in a patient diary sheet for up to 140 days.
Locations(6)
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NCT07372495