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

Primary Purpose

Miscarriage, Preterm Birth

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Miscarriage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Karma Medical Clinic
  • North York General Hospital
  • Jewish General Hospital
  • CHU Sainte-Justine
  • MUHC Royal Victoria Hospital
  • St. Mary's Hospital
  • Hôpital Fleurimont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Progesterone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Miscarriage
Occurrence of a miscarriage (<20 weeks)
Preterm birth
Occurrence of preterm birth (<37 weeks)

Secondary Outcome Measures

Maternal outcomes
Antenatal admissions, treatment of preterm labor etc.
Neonatal outcomes
Malformations, growth restriction, prematurity associated morbidity, etc.
Healthcare outcomes
Hospital costs, etc

Full Information

First Posted
May 14, 2014
Last Updated
August 19, 2021
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02145767
Brief Title
Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Official Title
Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage, Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Progesterone
Arm Type
Experimental
Arm Description
Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Miscarriage
Description
Occurrence of a miscarriage (<20 weeks)
Time Frame
From 6-8 weeks of pregnancy until miscarriage
Title
Preterm birth
Description
Occurrence of preterm birth (<37 weeks)
Time Frame
From 6-8 weeks of pregnancy until delivery
Secondary Outcome Measure Information:
Title
Maternal outcomes
Description
Antenatal admissions, treatment of preterm labor etc.
Time Frame
From 6-8 weeks of pregnancy until 6 weeks post delivery
Title
Neonatal outcomes
Description
Malformations, growth restriction, prematurity associated morbidity, etc.
Time Frame
2 days to 6 weeks post delivery
Title
Healthcare outcomes
Description
Hospital costs, etc
Time Frame
From 6-8 weeks of pregnancy until 6 weeks post delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Abenhaim, MD, MPH
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karma Medical Clinic
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2H 5Z8
Country
Canada
Facility Name
North York General Hospital
City
North York
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
MUHC Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
St. Mary's Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hôpital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

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

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