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

NCT02145767 | Completed Phase 2 DMC

• 1 other identifier: PRMT15
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 7

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.

Conditions

Miscarriage; Preterm Birth

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Maternal outcomes

  From 6-8 weeks of pregnancy until 6 weeks post delivery

• Neonatal outcomes

  2 days to 6 weeks post delivery

• Healthcare outcomes

  From 6-8 weeks of pregnancy until 6 weeks post delivery

Study Arms (2)

Progesterone

EXPERIMENTAL

Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy.

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy.

Drug: Placebo

Interventions

Progesterone DRUG

Progesterone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to Progesterone
• Any indication for progesterone

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (7)

Karma Medical Clinic

Kitchener, Ontario, N2H 5Z8, Canada

Location

North York General Hospital

North York, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, Canada

Location

MUHC Royal Victoria Hospital

Montreal, Quebec, Canada

Location

St. Mary's Hospital

Montreal, Quebec, Canada

Location

Hôpital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Abortion, Spontaneous; Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Haim Abenhaim, MD, MPH

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician & Gynecologist, Maternal Fetal Medicine Specialist, Director of Perinatal Research

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 23, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

CA (7)