Obstetric Labor, Premature Clinical Trial
Official title:
Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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