Vaginal Progesterone as a Treatment for Women Active Preterm Labor

NCT ID: NCT01206998

Last Updated: 2012-10-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-08-31

Brief Summary

The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.

Detailed Description

Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last two decades. Approximately 12.8% of births are preterm, however these account for more than 75% of all perinatal morbidity and mortality. Currently prophylactic progesterone administration is the most effective method available for the prevention of recurrent preterm birth. Prior studies have examined the impact of progesterone in women with recurrent preterm birth and cervical shortening. The possible use of progesterone in women experiencing active preterm labor may address the highest risk condition, however, there have not been any clinical trials to date examining this use of vaginal progesterone. Inflammation and decidual hemorrhage are among the proposed mechanisms that appear to be related to preterm labor.We will use a double blinded randomized drug placebo design to study the proposed outcomes in women diagnosed with preterm labor and planned to have standard of care tocolytic therapy. Women will be randomized to daily vaginal progesterone gel or placebo and will be maintained on the drug or placebo until delivery or 36 6/7 weeks.

Conditions

Labor, Premature

Keywords

preterm labor; progesterone; tocolysis; cervical length

Study Design

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

Study Groups

Vaginal progesterone gel

Group Type: EXPERIMENTAL

Vaginal progesterone gel

Intervention Type: DRUG

Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)

Placebo vaginal gel

Group Type: PLACEBO_COMPARATOR

Placebo vaginal gel

Intervention Type: DRUG

Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug

Interventions

Vaginal progesterone gel

Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)

Intervention Type: DRUG

Placebo vaginal gel

Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug

Intervention Type: DRUG

Other Intervention Names

Prochieve® 8%/Crinone 8%®; Replens®

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Singleton gestation
• Gestational age between 24 0/7 and 33 6/7 weeks of pregnancy by best obstetric estimate
• Preterm labor, defined as more than 6 uterine contractions in 30 minutes associated with cervical change, either shortening and/or dilation by manual exam.
• Management with standard of care tocolytic therapy (nifedipine)
• Planned delivery at Strong Memorial Hospital or Highland Hospital

Exclusion Criteria

• Cervical dilation more than 4 cm.
• Evidence of rupture of membranes
• Negative fetal fibronectin (if done prior to admission)
• Cervical length greater than 3 cm
• Presence of cervical cerclage
• Major fetal anomaly
• Small for gestational age, i.e., fetuses with estimated fetal weight below the 10th percentile by ultrasound
• Evidence of chorioamnionitis (Temperature >100.4oF with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
• Suspected placental abruption or significant hemorrhage
• Category III fetal heart rate pattern
• Presence of co-existing medical conditions, including maternal diabetes and hypertension and seizure disorder
• Use of any progesterone in current pregnancy within 4 weeks of enrollment
• First dose of standard tocolytic therapy more than 6 hours prior to randomization
• Allergies to progesterone and progesterone gel

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

Sponsors

Juniper Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Tulin Ozcan MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tulin Ozcan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Strong Memorial Hospital

Rochester, New York, United States

Countries

United States

Other Identifiers

VagPro 27515

Identifier Type: -

Identifier Source: org_study_id