Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Vaginal progesterone gel
- Conditions
- Preterm Birth
- Sponsor
- University of Calgary
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Gestational age
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Dr. Sue Ross
Adjunct Professor
University of Calgary
Eligibility Criteria
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
Arms & Interventions
1
Progesterone gel
Intervention: Vaginal progesterone gel
2
Vaginal gel with no medication
Intervention: Placebo gel
Outcomes
Primary Outcomes
Gestational age
Time Frame: Delivery
Secondary Outcomes
- 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)