RecruitingNot ApplicableNCT07372495

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


Sponsor

National Hospital of Obstetrics and Gynecology

Enrollment

260 participants

Start Date

Apr 10, 2026

Study Type

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

Sex: FEMALEMin Age: 18 Years

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 …)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURECervical cerclage

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.

DRUGProgesterone

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)

Bac Ninh 1 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam

Bac Ninh, Vietnam

Bac Ninh 2 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam

Bac Ninh, Vietnam

National Hospital of Obstetrics and Gynecology

Hanoi, Vietnam

Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam

Hung Yen, Vietnam

Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam

Ninh Binh, Vietnam

Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam

Quang Ninh, Vietnam

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07372495


Related Trials