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

NCT01286246 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-01-08

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Stephen Wood, MD, MSc · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286246 on ClinicalTrials.gov