Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07372495

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

Led by National Hospital of Obstetrics and Gynecology · Updated on 2026-04-24

260

Participants Needed

6

Research Sites

21 weeks

Total Duration

On this page

Sponsors

N

National Hospital of Obstetrics and Gynecology

Lead Sponsor

Q

Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the prevention of preterm birth in women with twin pregnancies who have a short cervix measuring 30 mm or less. The trial aims to compare the effects of combining cervical cerclage with vaginal progesterone versus using vaginal progesterone alone. This condition is important because twin pregnancies carry a higher risk of early birth, which can lead to serious health issues for newborns, including complications affecting vital organs and long-term developmental problems. Participants are randomly assigned to one of two groups: one group will receive a cervical cerclage procedure plus vaginal progesterone, while the other group will receive vaginal progesterone alone. The cerclage involves placing a suture around the cervix before 24 weeks of pregnancy under spinal anesthesia. Vaginal progesterone is given twice daily until 37 weeks of pregnancy or delivery. The procedure is performed by trained obstetricians, and participants record their progesterone use in a diary to track adherence. During the study, participants will have follow-up visits every one to two weeks until delivery. These visits include routine antenatal care, cervical length measurement, and checks for any complications or side effects. Researchers will monitor outcomes such as the timing of birth before 28 weeks, other preterm birth milestones, maternal and neonatal health, and hospital costs. Data will also be collected from medical records if delivery occurs outside the study centers. The trial follows participants from randomization until delivery and postpartum periods as specified.

CONDITIONS

Brief Title

Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Maternal age 18 years or older
  • Twin pregnancy
  • Asymptomatic short cervix with cervical length 30 mm or less at routine ultrasound
  • Gestational age between 16 weeks 0 days and 24 weeks 0 days
Not Eligible

You will not qualify if you...

  • Twin pregnancy with one or both fetuses having major structural or congenital abnormalities likely to affect neonatal outcomes
  • Monochorionic monoamniotic twin pregnancy
  • Monochorionic twin pregnancy with twin-to-twin transfusion syndrome before or at inclusion
  • History of recurrent late miscarriage or preterm birth two or more times indicating vaginal cerclage
  • Cervical dilatation diagnosed by ultrasound or physical exam
  • Symptoms of preterm labor at cervical measurement such as regular contractions or premature rupture of membranes
  • Fever of 38 degrees Celsius or higher
  • Placenta previa or vasa previa
  • Uterine malformations including unicornuate, bicornuate uterus, uterine septum, or fibroids
  • Severe maternal conditions like heart failure, chronic kidney disease, or systemic lupus erythematosus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for cervical length measurement between 16 and 24 weeks of gestation

Treatment

Duration - From randomization until 37 weeks of gestation or preterm birth, whichever comes first

Participants receive either cervical cerclage plus vaginal progesterone or vaginal progesterone alone to prevent preterm birth in twin pregnancies with a short cervix.

Initial treatment within one week after randomization; then follow-up visits every 2 weeks until delivery

Follow-up

Duration - From 7 days after randomization until delivery

Participants are monitored with routine antenatal care, cervical length measurements, and assessment of treatment compliance and any adverse events until delivery.

Visits 7 days after randomization and then every 2 weeks until delivery

Trial Site Locations

Total: 6 locations

1

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

Bac Ninh, Vietnam, 220000

Not Yet Recruiting

2

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

Bac Ninh, Vietnam, 220000

Not Yet Recruiting

3

National Hospital of Obstetrics and Gynecology

Hanoi, Vietnam, 100000

Actively Recruiting

4

Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam

Hung Yen, Vietnam, 160000

Not Yet Recruiting

5

Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam

Ninh Binh, Vietnam, 430000

Not Yet Recruiting

6

Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam

Quang Ninh, Vietnam, 200000

Not Yet Recruiting

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Research Team

T

Thu Ha T Nguyen, Assoc. Prof

V

Viet C Dang, MD, MsC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Cervical cerclage versus cervical pessary with or without vaginal progesterone for preterm birth prevention in twin pregnancies and a short cervix: A two-by-two factorial randomised clinical trial.

Yen T N He, Ha N H Pham, Tri C Nguyen...

https://pubmed.ncbi.nlm.nih.gov/39982935

Cervical cerclage for prevention of preterm birth and adverse perinatal outcome in twin pregnancies with short cervical length or cervical dilatation: A systematic review and meta-analysis.

Francesco D'Antonio, Nashwa Eltaweel, Smriti Prasad...

https://pubmed.ncbi.nlm.nih.gov/37535682

Emergency cervical cerclage in twin and singleton pregnancies with 0-mm cervical length or prolapsed membranes.

Georgina D Freegard, Vera Donadono, Lawrence W M Impey

https://pubmed.ncbi.nlm.nih.gov/34476806

Vaginal progesterone vs. cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis.

Agustin Conde-Agudelo, Roberto Romero, Kypros Nicolaides...

https://pubmed.ncbi.nlm.nih.gov/23157855