Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Drug: Vaginal progesterone gel; Drug: Placebo gel

• Registration Number: NCT00343265
• Lead Sponsor: University of Calgary

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-20
• Study First Submitted QC: 2006-06-20
• Study First Posted: 2006-06-22
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-14
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vaginal progesterone gel	Progesterone gel
2	Placebo gel	Vaginal gel with no medication

Primary Outcome Measures

Name	Time	Method
Gestational age	Delivery

Secondary Outcome Measures

Name	Time	Method
Birth weight	Birth
Infant morbidity and mortality	Discharge
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

Trial Locations

Locations (1)

Calgary Health Region; 🇨🇦 Calgary, Alberta, Canada