Natural Progesterone and Preterm Birth in Twins

NCT ID: NCT00480402

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-06-30

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 (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.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

400 mg Progesterone

Approximately one third of the bichorionic biamniotic twin pregnant women randomized to the 400 mg Progesterone Group vaginal pessaries arm.

Group Type: EXPERIMENTAL

400 mg Progesterone

Intervention Type: DRUG

Administration of 400 mg Progesterone

200 mg Progesterone Group

Approximately one third of the bichorionic biamniotic twin pregnant women randomized to the 200 mg Progesterone Group vaginal pessaries arm.

Group Type: EXPERIMENTAL

200 mg of Progesterone

Intervention Type: DRUG

Administration of 200 mg of Progesterone

Placebo

Approximately one third of the bichoronic biamniotic twin pregnant women were randomized to the placebo vaginal pessaries arm.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Administration of a Placebo

Interventions

200 mg of Progesterone

Administration of 200 mg of Progesterone

Intervention Type: DRUG

400 mg Progesterone

Administration of 400 mg Progesterone

Intervention Type: DRUG

Placebo

Administration of a Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Principal Investigators

Vicente Serra, MDPhD

Role: STUDY_DIRECTOR

Instituto Valenciano de la Infertilidad

Locations

Instituto Valenciano de la Infertilidad

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

VLC-VS-0405-507-23

Identifier Type: -

Identifier Source: org_study_id