Oral Progesterone for Prevention of Preterm Birth

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-01-31

Brief Summary

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To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

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Detailed Description

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To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Progesterone Group

Oral Micronized Progesterone

Group Type EXPERIMENTAL

oral micronized progesterone

Intervention Type DRUG

oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks

Placebo

Identical Placebo Tablet

Group Type PLACEBO_COMPARATOR

Identical Placebo tablet

Intervention Type DRUG

Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Interventions

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oral micronized progesterone

oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks

Intervention Type DRUG

Identical Placebo tablet

Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Intervention Type DRUG

Other Intervention Names

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Prometrium(TM) Placebo

Eligibility Criteria

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Inclusion Criteria

* pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 \& 0/7 weeks' and 36 \& 6/7 weeks' gestation.

Exclusion Criteria

* multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No