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

Information source: Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Miscarriage; Preterm Birth

Intervention: Progesterone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sir Mortimer B. Davis - Jewish General Hospital

Official(s) and/or principal investigator(s):
Haim Abenhaim, MD, MPH, Principal Investigator, Affiliation: Jewish General Hospital

Overall contact:
Andrea Spence, Phone: 514-418-0875, Email: preempttrial@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Miscarriage

Preterm birth

Secondary outcome:

Maternal outcomes

Neonatal outcomes

Healthcare outcomes

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Andrea Spence, Phone: 514-418-0875, Email: preempttrial@gmail.com

CHU Sainte-Justine, Montreal, Quebec, Canada; Recruiting
Nathalie Leroux, MD, FRCSC, Phone: 514 345 4931, Ext: 7768, Email: nathalielerouxmd@sympatico.ca
Francois Audibert, Sub-Investigator
Nathalie Leroux, Sub-Investigator

Jewish General Hospital, Montreal, Quebec H3T 1E2, Canada; Recruiting
Stephanie Klam, MD, FRCSC, Phone: 514-340-3666, Email: sklam@jgh.mcgill.ca
Stephanie Klam, Sub-Investigator

MUHC Royal Victoria Hospital, Montreal, Quebec, Canada; Recruiting
Robert Gagnon, MD, FRCS(c), Phone: (514) 934-1934, Ext: 31385, Email: robert.gagnon@muhc.mcgill.ca
Amira El-Messidi, Sub-Investigator
Robert Gagnon, Sub-Investigator

St. Mary's Hospital, Montreal, Quebec, Canada; Recruiting
Isabelle Girard, MD

Additional Information

Starting date: December 2014
Last updated: April 16, 2015

Page last updated: August 23, 2015

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