Status:
COMPLETED
Vaginal Progesterone Versus Placebo in Multiple Pregnancy
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Calgary Health Region
Juniper Pharmaceuticals, Inc.
Conditions:
Preterm Birth
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Confirmed multiple pregnancy
- Ultrasound confirmed minimum of 2 live fetuses
- Gestational age 16-20 6/7 weeks
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00343265
Start Date
June 1 2006
End Date
March 1 2011
Last Update
August 15 2013
Active Locations (1)
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1
Calgary Health Region
Calgary, Alberta, Canada, T2N 2T9