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

NCT ID: NCT01286246

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vaginal progesterone

Group Type: EXPERIMENTAL

Vaginal progesterone

Intervention Type: DRUG

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).

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Utrogestan

Eligibility Criteria

Inclusion Criteria

• Women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics.
• Women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive.
• Gestational age 23(+0)-32(+6) weeks.
• Consent to taking part in the study.

Exclusion Criteria

• Placenta previa
• Preterm premature rupture of membranes at presentation
• Pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women
• Known major fetal anomaly detected on ultrasound
• Multiple pregnancy
• Maternal seizure disorder
• Active or history of thromboembolic disease
• Maternal liver disease
• Known or suspected breast malignancy or pathology
• Known or suspected progesterone-dependent neoplasia
• Plans to move to another city during pregnancy
• Previous participation in a progesterone trial during this pregnancy
• Known sensitivity to progesterone

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sue Ross

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Wood, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

21492

Identifier Type: -

Identifier Source: org_study_id