Preterm Delivery Prevention in Twins With Progesterone
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01927029|
Recruitment Status : Unknown
Verified August 2013 by Masami Yamamoto, Clinica Alemana de Santiago.
Recruitment status was: Active, not recruiting
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Universidad del Desarrollo
Hospital Padre Hurtado
Hospital San Borja-Arriaran
Information provided by (Responsible Party):
Masami Yamamoto, Clinica Alemana de Santiago
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%.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancies||Drug: Progesterone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||213 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||December 2014|
Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks.
Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.
Other Name: Progendo gel
Placebo Comparator: Placebo
Placebo Gel, for daily use from 18 weeks to 34 weeks.
Primary Outcome Measures :
- Preterm delivery <34 weeks [ Time Frame: 14 months ]Spontaneous labor under 34 weeks.
Secondary Outcome Measures :
- Preterm delivery <37 weeks [ Time Frame: 14 months ]Spontaneous delivery under 37 weeks
Other Outcome Measures:
- Neonatal mortality [ Time Frame: 14 months ]Dead of the newborn, due to preterm delivery
No Contacts or Locations Provided