Oral Progesterone for Prevention of Preterm Birth

Fetal Medicine Foundation36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Preterm Birth

Interventions

oral micronized progesteroneDRUG

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

Identical Placebo tabletDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Miami Valley HospitaL

Dayton, Ohio, United States

Outcomes

Primary Outcomes

Rate of Recurrent Preterm Birth

Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.

Time frame: Prior to 37 weeks' gestation

Secondary Outcomes

Serum progesterone levels

Time frame: Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group

Data from ClinicalTrials.gov

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