Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Miscarriage [From 6-8 weeks of pregnancy until miscarriage]
Occurrence of a miscarriage (<20 weeks)
- Preterm birth [From 6-8 weeks of pregnancy until delivery]
Occurrence of preterm birth (<37 weeks)
Secondary Outcome Measures
- Maternal outcomes [From 6-8 weeks of pregnancy until 6 weeks post delivery]
Antenatal admissions, treatment of preterm labor etc.
- Neonatal outcomes [2 days to 6 weeks post delivery]
Malformations, growth restriction, prematurity associated morbidity, etc.
- Healthcare outcomes [From 6-8 weeks of pregnancy until 6 weeks post delivery]
Hospital costs, etc
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karma Medical Clinic | Kitchener | Ontario | Canada | N2H 5Z8 |
| 2 | North York General Hospital | North York | Ontario | Canada | |
| 3 | Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 4 | CHU Sainte-Justine | Montreal | Quebec | Canada | |
| 5 | MUHC Royal Victoria Hospital | Montreal | Quebec | Canada | |
| 6 | St. Mary's Hospital | Montreal | Quebec | Canada | |
| 7 | Hôpital Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
Sponsors and Collaborators
- Sir Mortimer B. Davis - Jewish General Hospital
- Canadian Institutes of Health Research (CIHR)
Investigators
- Principal Investigator: Haim Abenhaim, MD, MPH, Jewish General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRMT15