Comparing cervical cerclage with progesterone to progesterone alone for preventing preterm birth
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
NA · Mỹ Đức Hospital · NCT06463652
This study tests whether combining a cervical stitch with progesterone can help pregnant women with a short cervix prevent preterm birth better than using progesterone alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mỹ Đức Hospital (other) |
| Locations | 1 site (Ho Chi Minh City, Ho Chi Minh City) |
| Trial ID | NCT06463652 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a singleton pregnancy and a cervical length of 25 mm or less.
Not a fit: Patients with cervical dilation, major fetal abnormalities, or other specified complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of preterm births in at-risk women.
How similar studies have performed: Previous studies have shown promising results with similar interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Ho Chi Minh City, Ho Chi Minh City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Birth, Short Cervix, Cerclage, Progesterone, Singleton, Preterm birth