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

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase: Completed; Phase 2

Conditions: Miscarriage; Preterm Birth

Treatments: Drug: Progesterone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02145767

PRMT15

Details and patient eligibility

About

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.

Enrollment: 850 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Contraindication to Progesterone
• Any indication for progesterone

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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850 participants in 2 patient groups, including a placebo group

Progesterone

Experimental group

Description:

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

Treatment:

Drug: Progesterone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo