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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Miscarriage
• Intervention / Treatment: Drug: Placebo; Drug: Progesterone

• Study Type: Interventional
• Enrollment (Anticipated): 850
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kitchener, Ontario, Canada, N2H 5Z8
      • Karma Medical Clinic
    • North York, Ontario, Canada
      • North York General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada
      • CHU Sainte-Justine
    • Montreal, Quebec, Canada
      • St. Mary's Hospital
    • Montreal, Quebec, Canada
      • MUHC Royal Victoria Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Hôpital Fleurimont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progesterone; Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy.	Drug: Progesterone
Placebo Comparator: Placebo; Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Miscarriage	Occurrence of a miscarriage (<20 weeks)	From 6-8 weeks of pregnancy until miscarriage
Preterm birth	Occurrence of preterm birth (<37 weeks)	From 6-8 weeks of pregnancy until delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Haim Abenhaim, MD, MPH, Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Abortion, Spontaneous; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: PRMT15