Vaginal Progesterone as a Treatment for Women Active Preterm Labor (VagPro)

Vaginal Progesterone in Patients With Active Preterm Labor

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.

Study Overview

• Status: Withdrawn
• Conditions: Labor, Premature
• Intervention / Treatment: Drug: Vaginal progesterone gel; Drug: Placebo vaginal gel

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal progesterone gel	Drug: Vaginal progesterone gel; Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone); Other Names: Prochieve® 8%/Crinone 8%®
Placebo Comparator: Placebo vaginal gel	Drug: Placebo vaginal gel; Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug; Other Names: Replens®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Latency to delivery	Time in days from randomization day to day of end of pregnancy

Secondary Outcome Measures

Outcome Measure	Time Frame
Cervical length	within 24 hours of first tocolytic dose and at first week follow up
Delivery prior to 37, 34 and 32 weeks	after delivery
Number of subsequent hospital admissions for preterm labor	after delivery

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Juniper Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Tulin Ozcan, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: September 20, 2010
• First Submitted That Met QC Criteria: September 21, 2010
• First Posted (Estimate): September 22, 2010

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 28, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: cervical length; preterm labor; tocolysis; progesterone
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: VagPro 27515