drugset / Trial / NCT01927029
Preterm Delivery Prevention in Twins With Progesterone
Phase 4
Unknown
213 enrolled
Universidad del Desarrollo
Hospital Padre Hurtado · collabHospital San Borja-Arriaran · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery \<34weeks from 13% to 7%.
Timeline
- Start
- 2013-08
- Primary completion
- 2014-10
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Progesterone | Other / unclassified | 180 mg | Intravenous |
Indications
No indication recorded.