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: MiscarriagePreterm birth
Secondary outcome: Maternal outcomesNeonatal 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
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