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Natural Progesterone and Preterm Birth in Twins

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

To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.


Condition Intervention Phase
Preterm Birth
 Drug: 200 mg of Progesterone
Drug: 400 mg Progesterone
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Eficacia de Los Suplementos de Progesterona Natural en la prevención Del Parto pretérmino Gemelar

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Enrollment: 290
Study Start Date: January 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Placebo
Administration of a Placebo

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 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480402

Locations
Spain
Instituto Valenciano de la Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Study Director: Vicente Serra, MDPhD Instituto Valenciano de la Infertilidad
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480402     History of Changes
Other Study ID Numbers: VLC-VS-0405-507-23
Study First Received: May 28, 2007
Last Updated: April 3, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
preterm birth
progesterone
twins
Preterm birth in twin gestations

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
 Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013