NCT00480402

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

May 28, 2007

Last Update Submit

April 3, 2013

Conditions

Preterm Birth

Keywords

preterm birthprogesteronetwinsPreterm birth in twin gestations

Study Arms (3)

400 mg Progesterone

EXPERIMENTAL

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

Drug: 400 mg Progesterone

200 mg Progesterone Group

EXPERIMENTAL

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

Placebo

ACTIVE COMPARATOR

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

Drug: Placebo

Interventions

200 mg of ProgesteroneDRUG

Administration of 200 mg of Progesterone

200 mg Progesterone Group
400 mg ProgesteroneDRUG

Administration of 400 mg Progesterone

400 mg Progesterone
PlaceboDRUG

Administration of a Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de la Infertilidad

Valencia, Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Vicente Serra, MDPhD

    Instituto Valenciano de la Infertilidad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2007

First Posted

May 30, 2007

Study Start

January 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

ES(1)