Using vaginal progesterone to help manage preterm labor
Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial
PHASE4 · Chulalongkorn University · NCT05997563
This study is testing if adding vaginal progesterone to the usual treatment can help women with preterm labor have better outcomes.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Chulalongkorn University (other) |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT05997563 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding vaginal micronized progesterone effervescent to the standard treatment for preterm labor. Participants will be divided into two groups: one receiving the progesterone along with standard treatment, and the other receiving only the standard treatment. The aim is to determine if the addition of progesterone can improve outcomes for women experiencing preterm labor.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with a singleton pregnancy between 24 and 33 weeks 6 days gestation who are experiencing preterm labor and have received tocolysis and corticosteroids.
Not a fit: Patients who have conditions requiring immediate delivery, significant medical complications, or contraindications to progesterone or tocolytic use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the management of preterm labor, potentially leading to better outcomes for both mothers and infants.
How similar studies have performed: Other studies have shown promise in using progesterone for managing preterm labor, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * singleton pregnancy with gestational age 24-33 weeks 6 days * preterm labor * received treatment with tocolysis and corticosteroids Exclusion Criteria: * conditions that need immediate delivery such as fetal distress, chorioamnionitis * have medical complications such as heart disease, seizure * fetal anomalies * cervical dilatation more than 5 cm * allergy to progesterone * contraindication to progesterone * contraindication to tocolytic use
Where this trial is running
Bangkok
- Vorapong Phupong — Bangkok, Thailand (RECRUITING)
Study contacts
- Study coordinator: Vorapong Phupong, M.D.
- Email: vorapong.p@chula.ac.th
- Phone: +66816339296
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 Labor