Oral Micronized Progesterone for Prevention of Preterm Birth

6 Nov, 10

Oral Micronized Progesterone for Prevention of Preterm Birth²

Aim

To evaluate the efficacy, safety and adverse effects of oral micronized progesterone (OMP) to prevent preterm birth (PTB)

Material & Methods

A randomized, double-blind, placebo-controlled trial including 150 women with at least one PTB received-

100 mg of OMP twice a day (N=75) or
Placebo twice a day (N =75)
From recruitment (18-24 weeks) until 36 weeks or delivery

Asymptomatic women aged between 18 and 35 years who were between 18 and 24 weeks of pregnancy, with a history of at least 1 spontaneous preterm delivery (between 20 weeks and 36 weeks + 6 days) and with a singleton live pregnancy

Exclusion Criteria

Women with first trimester bleeding, premature rupture of membranes, multiple pregnancy, fetal anomalies or active liver disease

Primary Outcome Measures

To evaluate the mean prolongation of pregnancy in weeks and days of gestation
To determine the risk of delivery at various gestational ages

Secondary Outcome Measures

Neonatal outcome
Response to tocolytics
Inhibition of preterm labor
Adverse effects or drug toxicity

Results

Lesser number of women on OMP had preterm delivery

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OMP prolonged pregnancy compared to control group

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OMP increased gestational age at delivery
OMP had protective role in preventing PTB between 28 and 31 weeks+ 6 days
OMP reduced need of tocolysis
Time interval from tocolysis to delivery was prolonged
Minimal adverse effects seen in both groups

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Int J Gynaecol Obstet. 2009;104(1):40-3