Cerclage plus progesterone versus progesterone alone for twins with a short cervix

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Hospital of Obstetrics and Gynecology
  Hanoi, Vietnam Recruiting
• 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
• 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 Bình, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.