Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Study Overview
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Brief Summary
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The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.

Detailed Description
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Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.

Official Title
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Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy

Conditions
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Preterm Birth

Intervention / Treatment
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* Drug: Vaginal progesterone gel
* Drug: Placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed multiple pregnancy Ultrasound confirmed minimum of 2 live fetuses Gestational age 16-20 6/7 weeks Exclusion Criteria: Placenta previa Pre-existing hypertension Major fetal anomaly Monoamniotic, monozygotic multiples Maternal seizure disorder History of, or active, thromboembolic disease Maternal live disease Breast malignancy or pathology Progesterone dependent neoplasia Plans to move to another city during pregnancy Sensitivity to progesterone Participation in other clinical trials during the pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Progesterone gel | Drug: Vaginal progesterone gel<br>* Vaginal gel once daily<br>|
| Placebo Comparator: 2<br>Vaginal gel with no medication | Drug: Placebo gel<br>* once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age |  | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women delivering < 35 weeks |  | Delivery | 
| Proportion of women delivering < 37 weeks |  | Delivery | 
| Proportion of women having spontaneous preterm delivery |  | Delivery | 
| Proportion of women having tocolytic therapy |  | During pregnancy | 
| Treatment compliance |  | Delivery | 
| Length of stay for mother and infants |  | Discharge | 
| Infant morbidity and mortality |  | Discharge | 
| Birth weight |  | Birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm birth, Multiple pregnancy, Vaginal progesterone, Preterm birth in multiple pregnancy