Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480402
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2007-05-28
Brief Title:
Natural Progesterone and Preterm Birth in Twins
Sponsor:
Instituto Valenciano de Infertilidad IVI VALENCIA
Organization:
Instituto Valenciano de Infertilidad IVI VALENCIA
Study Overview
Official Title:
Eficacia de Los Suplementos de Progesterona Natural en la prevención Del Parto pretérmino Gemelar
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins
Detailed Description:
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 N82 II 200 mg progesterone N82 and III 400 mg progesterone N82
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
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 N82 II 200 mg progesterone N82 and III 400 mg progesterone N82
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None