Natural Progesterone and Preterm Birth in Twins

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00480402
First received: May 28, 2007
Last updated: April 3, 2013
Last verified: April 2013

May 28, 2007
April 3, 2013
January 2006
June 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00480402 on ClinicalTrials.gov Archive Site
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Not Provided
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Natural Progesterone and Preterm Birth in Twins
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Preterm Birth
  • Drug: 200 mg of Progesterone
    Administration of 200 mg of Progesterone
  • Drug: 400 mg Progesterone
    Administration of 400 mg Progesterone
  • Drug: Placebo
    Administration of a Placebo
  • Experimental: 400 mg Progesterone
    Approximately one third of the bichorionic biamniotic twin pregnant women randomized to the 400 mg Progesterone Group vaginal pessaries arm.
    Intervention: Drug: 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.
    Intervention: Drug: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bichorionic biamniotic twin pregnant women
  • = or > 18 years old

Exclusion Criteria:

  • Single pregnancy or monochorionic twin pregnancy or triplets
  • Chronic hepatic pathology, previous alterations in hepatic analysis during anti-contraceptive treatment; or gestational cholestasis in in previous pregnancies.Basal alterations in hepatic analysis profile.
  • Profylactic cerclage until week 14.
  • Basal alterations in renal analysis profile
  • Local allergy to micronized natural progesterone
  • Genital pathology not allowing for correct absorption of medication
  • Fetal anomoly diagnosed after sonograph week 12 and/or 20.
  • Smokers of more than 10 cigarettes/day
  • Consumers of illegal substances
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00480402
VLC-VS-0405-507-23
Yes
Not Provided
Instituto Valenciano de Infertilidad, IVI VALENCIA
Not Provided
Study Director: Vicente Serra, MDPhD Instituto Valenciano de la Infertilidad
Instituto Valenciano de Infertilidad, IVI VALENCIA
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP