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

NCT01286246 | Terminated Phase 4

• 1 other identifier: 21492
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Progesterone; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Gestational age at birth

  Gestational age at birth calculated from gestational age at pre-randomization baseline

  At birth

Secondary Outcomes (12)

• 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

Study Arms (2)

Vaginal progesterone

EXPERIMENTAL

Drug: Vaginal progesterone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Vaginal progesterone 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).

Also known as: Utrogestan

Vaginal progesterone

Placebo 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).

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 4J8, Canada

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Utrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Stephen Wood, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

CA (1)