Natural Progesterone and Preterm Birth in Twins
|Preterm Birth||Drug: 200 mg of Progesterone Drug: 400 mg Progesterone Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Eficacia de Los Suplementos de Progesterona Natural en la prevención Del Parto pretérmino Gemelar|
|Study Start Date:||January 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: 400 mg Progesterone
Approximately one third of the bichorionic biamniotic twin pregnant women randomized to the 400 mg Progesterone Group vaginal pessaries arm.
Drug: 400 mg Progesterone
Administration of 400 mg Progesterone
Experimental: 200 mg Progesterone Group
Approximately one third of the bichorionic biamniotic twin pregnant women randomized to the 200 mg Progesterone Group vaginal pessaries arm.
Drug: 200 mg of Progesterone
Administration of 200 mg of Progesterone
Active Comparator: Placebo
Approximately one third of the bichoronic biamniotic twin pregnant women were randomized to the placebo vaginal pessaries arm.
Administration of a Placebo
Objective: To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.
Study Design: National multicenter randomized double blind controlled clinical trial.
Setting: Six tertiary hospitals in the east of Spain (communities of Valencia and Murcia): Instituto Universitario IVI Valencia, Hospital Universitario La Fe (Valencia), Hospital Universitario Dr. Peset (Valencia), Hospital General Universitario (Alicante), Hospital Vega Baja de Orihuela (Alicante) y Hospital Virgen de la Arrixaca (Murcia).
Population: 246 bichorionic biamniotic twin pregnant women divided in three groups according to the allocated randomized treatment: (I) placebo (N=82); (II) 200 mg progesterone (N=82); and (III) 400 mg progesterone (N=82).
Methods: All participant women will self-administer two vaginal pessaries at bedtime containing the allocated treatment. Vaginal pessaries will be identical externally but will contain either placebo or 200 mg of natural progesterone (Laboratorios Effik, Madrid, Spain). The treatment will be applied from the 20th week until the 34th week (or until delivery if it occurred earlier). Control visits will be performed at 24, 28, 32 and 34 weeks. Pregnancies will be managed according to each local protocol. An external statistical analysis will be performed on intention to treat basis.
Main outcome measure: Preterm birth rate (<37 weeks). Secondary outcome measures: very preterm birth rate (<32 weeks); cervical length measured by vaginal ultrasound at each control visit; need for tocolytic treatments; rate of preterm premature rupture of membranes; and perinatal morbidity and mortality.
Estimated period of study: 2006-2008.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480402
|Instituto Valenciano de la Infertilidad|
|Valencia, Spain, 46015|
|Study Director:||Vicente Serra, MDPhD||Instituto Valenciano de la Infertilidad|