Vaginal Progesterone Versus Placebo in Multiple Pregnancy

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

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.

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