Clinical trial NCT02145767: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Miscarriage
Preterm Birth
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-05-23
Enrollment: 850
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Miscarriage
timeFrame: From 6-8 weeks of pregnancy until miscarriage
measure: Preterm birth
timeFrame: From 6-8 weeks of pregnancy until delivery
Secondary outcomes:
measure: Maternal outcomes
timeFrame: From 6-8 weeks of pregnancy until 6 weeks post delivery
measure: Neonatal outcomes
timeFrame: 2 days to 6 weeks post delivery
measure: Healthcare outcomes
timeFrame: From 6-8 weeks of pregnancy until 6 weeks post delivery
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Karma Medical Clinic
state: Ontario
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: MUHC Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: St. Mary's Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Hôpital Fleurimont
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Haim Abenhaim, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: