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

Study Overview
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Brief Summary
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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.

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

Conditions
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Miscarriage, Preterm Birth

Intervention / Treatment
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* Drug: Progesterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone<br>Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy. | Drug: Progesterone<br> <br> |
| Placebo Comparator: Placebo<br>Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 2 days to 6 weeks post delivery | 
| Healthcare outcomes | Hospital costs, etc | From 6-8 weeks of pregnancy until 6 weeks post delivery |