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

This study has been withdrawn prior to enrollment.
(Withdrawal of support of the drug company for drug and placebo)
Sponsor:
Collaborator:
Columbia Laboratories
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01206998
First received: September 20, 2010
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Labor, Premature
Drug: Vaginal progesterone gel
Drug: Placebo vaginal gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal Progesterone in Patients With Active Preterm Labor

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Latency to delivery [ Time Frame: Time in days from randomization day to day of end of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cervical length [ Time Frame: within 24 hours of first tocolytic dose and at first week follow up ] [ Designated as safety issue: No ]
  • Delivery prior to 37, 34 and 32 weeks [ Time Frame: after delivery ] [ Designated as safety issue: No ]
  • Number of subsequent hospital admissions for preterm labor [ Time Frame: after delivery ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Replens®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206998

Locations
United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Columbia Laboratories
Investigators
Principal Investigator: Tulin Ozcan, MD University of Rochester
  More Information

No publications provided

Responsible Party: Tulin Ozcan MD, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT01206998     History of Changes
Other Study ID Numbers: VagPro 27515
Study First Received: September 20, 2010
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Rochester:
preterm labor
progesterone
tocolysis
cervical length

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on October 23, 2014