Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone | Experimental | Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy. |
|
| Placebo | Placebo Comparator | Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Miscarriage | Occurrence of a miscarriage (<20 weeks) | From 6-8 weeks of pregnancy until miscarriage |
| Preterm birth | Occurrence of preterm birth (<37 weeks) | From 6-8 weeks of pregnancy until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal outcomes | Antenatal admissions, treatment of preterm labor etc. | From 6-8 weeks of pregnancy until 6 weeks post delivery |
| Neonatal outcomes | Malformations, growth restriction, prematurity associated morbidity, etc. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Haim Abenhaim, MD, MPH | Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karma Medical Clinic | Kitchener | Ontario | N2H 5Z8 | Canada | ||
| North York General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 days to 6 weeks post delivery |
| Healthcare outcomes | Hospital costs, etc | From 6-8 weeks of pregnancy until 6 weeks post delivery |
| North York |
| Ontario |
| Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CHU Sainte-Justine | Montreal | Quebec | Canada |
| MUHC Royal Victoria Hospital | Montreal | Quebec | Canada |
| St. Mary's Hospital | Montreal | Quebec | Canada |
| Hôpital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
Not provided
Not provided