Trials / Unknown
UnknownNCT01927029
Preterm Delivery Prevention in Twins With Progesterone
Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Universidad del Desarrollo · Academic / Other
- Sex
- Female
- Age
- 14 Years – 45 Years
- Healthy volunteers
- Not accepted
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%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Progesterone | Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks. |
| DRUG | Placebo |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2014-10-01
- Completion
- 2014-12-01
- First posted
- 2013-08-21
- Last updated
- 2013-08-21
Source: ClinicalTrials.gov record NCT01927029. Inclusion in this directory is not an endorsement.