RecruitingNot ApplicableNCT06463652

Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies

Cervical Cerclage With Vaginal Progesterone Versus Vaginal Progesterone Only for Preterm Birth Prevention in Women With a Singleton Pregnancy and a Short Cervical Length: a Randomized Clinical Trial

Sponsor

Mỹ Đức Hospital

Enrollment

328 participants

Start Date

Jun 26, 2024

Study Type

INTERVENTIONAL

Conditions

Preterm Birth

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria14

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.)