Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies (NCT06463652) | Clinical Trial Compass
RecruitingNot Applicable
Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies
Vietnam328 participantsStarted 2024-06-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
What they're measuring
1
Time from randomization to delivery
Timeframe: From date of randomization until the date of delivery