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

Primary Purpose

Labor, Premature

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaginal progesterone gel
Placebo vaginal gel
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor, Premature focused on measuring preterm labor, progesterone, tocolysis, cervical length

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Strong Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaginal progesterone gel

Placebo vaginal gel

Arm Description

Outcomes

Primary Outcome Measures

Latency to delivery

Secondary Outcome Measures

Cervical length
Delivery prior to 37, 34 and 32 weeks
Number of subsequent hospital admissions for preterm labor

Full Information

First Posted
September 20, 2010
Last Updated
September 28, 2012
Sponsor
University of Rochester
Collaborators
Juniper Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01206998
Brief Title
Vaginal Progesterone as a Treatment for Women Active Preterm Labor
Acronym
VagPro
Official Title
Vaginal Progesterone in Patients With Active Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawal of support of the drug company for drug and placebo
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Juniper Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor, Premature
Keywords
preterm labor, progesterone, tocolysis, cervical length

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal progesterone gel
Arm Type
Experimental
Arm Title
Placebo vaginal gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vaginal progesterone gel
Other Intervention Name(s)
Prochieve® 8%/Crinone 8%®
Intervention Description
Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)
Intervention Type
Drug
Intervention Name(s)
Placebo vaginal gel
Other Intervention Name(s)
Replens®
Intervention Description
Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug
Primary Outcome Measure Information:
Title
Latency to delivery
Time Frame
Time in days from randomization day to day of end of pregnancy
Secondary Outcome Measure Information:
Title
Cervical length
Time Frame
within 24 hours of first tocolytic dose and at first week follow up
Title
Delivery prior to 37, 34 and 32 weeks
Time Frame
after delivery
Title
Number of subsequent hospital admissions for preterm labor
Time Frame
after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tulin Ozcan, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaginal Progesterone as a Treatment for Women Active Preterm Labor

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