Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 6:17 PM
Study NCT ID:
NCT02145767
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2014-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Organization:
Study Overview
Official Title:
Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: