Miscarriage, Preterm Birth
Conditions
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.
Interventions
DRUGProgesterone
DRUGPlacebo
Sponsors
Canadian Institutes of Health Research (CIHR)
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed