NCT06463652 Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies
| NCT ID | NCT06463652 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mỹ Đức Hospital |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 328 participants |
| Start Date | 2024-06-26 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 328 participants in total. It began in 2024-06-26 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.)
Contact & Investigator
Lan N Vuong, MD, PhD
PRINCIPAL INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City
Frequently Asked Questions
Who can join the NCT06463652 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06463652 currently recruiting?
Yes, NCT06463652 is actively recruiting participants. Contact the research team at bsthanh.lv@myduchospital.vn for enrollment information.
Where is the NCT06463652 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06463652 clinical trial?
NCT06463652 is sponsored by Mỹ Đức Hospital. The principal investigator is Lan N Vuong, MD, PhD at University of Medicine and Pharmacy at Ho Chi Minh City. The trial plans to enroll 328 participants.