Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2021-02-28

Brief Summary

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Miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key role during pregnancy, has been proposed as a possible medication to be used in pregnancy to prevent miscarriage and preterm birth among women who have bleeding in their first trimester of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The purpose of our study is to evaluate the effect of progesterone for the prevention of miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a clinical trial in which 850 women will be randomized to receive either progesterone supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of their pregnancy will be compared.

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Detailed Description

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Conditions

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Miscarriage 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

Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy.

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

Placebo

Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Progesterone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Live intrauterine singleton pregnancy of \<14 weeks by crown-rump length on ultrasound with documented fetal cardiac activity
* Presence of a perigestational (subchorionic) hemorrhage on ultrasound