Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies
Recruiting now · Not applicable
Conditions studied: Preterm Birth, Short Cervix
In brief
This study compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.
Key facts
- Study ID
- NCT06463652
- Run by
- Mỹ Đức Hospital
- People needed
- 328
- Starts
- 2024-06-26
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-09-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- My Duc Hospital — Ho Chi Minh City, Ho Chi Minh City, Vietnam (enrolling)
Full record on ClinicalTrials.gov
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