Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial

Preterm Birth Clinical Trial

Official title:

Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145767
• Other study ID #: PRMT15
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: February 2021

Study information

• Verified date: August 2021
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage
• Premature Birth
• Preterm Birth

Intervention

Drug:
• Progesterone

• Placebo

Locations

Country	Name	City	State
Canada	Karma Medical Clinic	Kitchener	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	MUHC Royal Victoria Hospital	Montreal	Quebec
Canada	St. Mary's Hospital	Montreal	Quebec
Canada	North York General Hospital	North York	Ontario
Canada	Hôpital Fleurimont	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Miscarriage	Occurrence of a miscarriage (<20 weeks)	From 6-8 weeks of pregnancy until miscarriage
Primary	Preterm birth	Occurrence of preterm birth (<37 weeks)	From 6-8 weeks of pregnancy until delivery
Secondary	Maternal outcomes	Antenatal admissions, treatment of preterm labor etc.	From 6-8 weeks of pregnancy until 6 weeks post delivery
Secondary	Neonatal outcomes	Malformations, growth restriction, prematurity associated morbidity, etc.	2 days to 6 weeks post delivery
Secondary	Healthcare outcomes	Hospital costs, etc	From 6-8 weeks of pregnancy until 6 weeks post delivery