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

Phase 2

Completed

• Conditions: Preterm Birth; Miscarriage
• Interventions: Drug: Placebo; Drug: Progesterone

• Registration Number: NCT02145767
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Study Start: 2014-12
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 850

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy.
Progesterone	Progesterone	Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy.

Primary Outcome Measures

Name	Time	Method
Miscarriage	From 6-8 weeks of pregnancy until miscarriage	Occurrence of a miscarriage (\<20 weeks)
Preterm birth	From 6-8 weeks of pregnancy until delivery	Occurrence of preterm birth (\<37 weeks)

Secondary Outcome Measures

Name	Time	Method
Healthcare outcomes	From 6-8 weeks of pregnancy until 6 weeks post delivery	Hospital costs, etc
Maternal outcomes	From 6-8 weeks of pregnancy until 6 weeks post delivery	Antenatal admissions, treatment of preterm labor etc.
Neonatal outcomes	2 days to 6 weeks post delivery	Malformations, growth restriction, prematurity associated morbidity, etc.

Trial Locations

Locations (7)

St. Mary's Hospital; 🇨🇦 Montreal, Quebec, Canada

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

MUHC Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Karma Medical Clinic; 🇨🇦 Kitchener, Ontario, Canada

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

North York General Hospital; 🇨🇦 North York, Ontario, Canada

Hôpital Fleurimont; 🇨🇦 Sherbrooke, Quebec, Canada