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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
Vaginal gel once daily
once daily
Calgary Health Region
Calgary, Alberta, Canada
Gestational age
Time frame: Delivery
Proportion of women delivering < 35 weeks
Time frame: Delivery
Proportion of women delivering < 37 weeks
Time frame: Delivery
Proportion of women having spontaneous preterm delivery
Time frame: Delivery
Proportion of women having tocolytic therapy
Time frame: During pregnancy
Treatment compliance
Time frame: Delivery
Length of stay for mother and infants
Time frame: Discharge
Infant morbidity and mortality
Time frame: Discharge
Birth weight
Time frame: Birth
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