Preterm Birth Clinical Trial
Official title:
Eficacia de Los Suplementos de Progesterona Natural en la prevención Del Parto pretérmino Gemelar
To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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