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

Phase 4

Terminated

• Conditions: Obstetric Labor, Premature
• Interventions: Drug: Vaginal progesterone; Drug: Placebo

• Registration Number: NCT01286246
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone	Vaginal progesterone	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Gestational age at birth	At birth	Gestational age at birth calculated from gestational age at pre-randomization baseline

Secondary Outcome Measures

Name	Time	Method
Proportion of women who have preterm birth <35 weeks	At birth
Proportion of women who have a preterm birth at <37 weeks	At birth
Maternal hospital length of stay (days)	Days from date of admission to date of discharge
Proportion of women who have hospital admission for premature labor	After birth
Maternal compliance with treatment	At time of birth	Diary self-report of treatment use
Neonatal hospital length of stay (days)	Days from birth to discharge from hospital
Neonatal morbidity	Up to 28 days after birth	Respiratory distress syndrome (type 1), intraventricular hemorrhage, chronic lung disease, periventricular leukomalacia,necrotising eneterocolitis, retinopathy of prematurity
Number of days of assisted ventilation (neonate)	Up to 28 days after birth
Number of days of supplemental oxygen (for neonate)	Up to 28 days after birth
Birth weight (grams)	At time of birth
Neonatal survival to discharge home (yes/no)	During 28 days after birth
Adverse events (maternal or neonate)	Up to 28 days after birth

Trial Locations

Locations (1)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada