Comparing cervical cerclage with progesterone to progesterone alone for preventing preterm birth

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

This clinical trial evaluates the effectiveness of combining cervical cerclage with vaginal progesterone versus using vaginal progesterone alone to prevent preterm birth in women with singleton pregnancies and a short cervical length. Participants will be randomly assigned to one of the two treatment groups, with the study conducted in an open-label format across multiple centers. The trial aims to enroll women between 16 to 24 weeks of gestation who have a cervical length of 25 mm or less, ensuring careful monitoring and adherence to local treatment protocols.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Maternal age ≥18 years
* Singleton pregnancy
* Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7 - 24 0/7 weeks of gestation)
* Not participating in any other study which has intervention on maternity or fetus
* Provision of written informed consent as shown by a signature on the participant consent form.

Exclusion Criteria:

* Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
* Major congenital abnormalities of the fetus
* Intrauterine fetal demise
* Presence of severe vaginal discharge\*
* Presence of vaginitis or cervicitis\*
* Presence of vaginal bleeding\*
* Placenta previa or vasa previa
* Preterm premature rupture of membranes
* Preterm labor without ruptured membrane at the time of screening
* Suspected chorioamnionitis
* Unable to undergo cerclage
* Cerclage in place
* Allergy to progesterone

(\*Women with acute cervicitis, vaginitis or severe vaginal discharge are eligible once they have been treated and if they have a CL ≤25 mm between 16 0/7 - 24 0/7 weeks of gestation.)

Where it's running

• My Duc Hospital
  Ho Chi Minh City, Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Principal investigator: Lan N Vuong, MD, PhD — University of Medicine and Pharmacy at Ho Chi Minh City
• Study coordinator: Thanh V Le, MD
• Email: bsthanh.lv@myduchospital.vn
• Phone: +84934124733

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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.