NCT01286246

Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor

Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor. Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in. Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment. When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.

Conditions

• Obstetric Labor, Premature

Interventions

Type	Name	Description
DRUG	Vaginal progesterone	Capsules of 200mg micronised progesterone suspended in sunflower oil. One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).
DRUG	Placebo	Capsules of placebo (sunflower oil). One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-01-31
• Last updated: 2015-01-08

Locations

1 site across 1 country: Canada