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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01206998
Recruitment Status : Withdrawn (Withdrawal of support of the drug company for drug and placebo)
First Posted : September 22, 2010
Last Update Posted : October 1, 2012
Juniper Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Labor, Premature Drug: Vaginal progesterone gel Drug: Placebo vaginal gel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal Progesterone in Patients With Active Preterm Labor
Study Start Date : July 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

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 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®

Primary Outcome Measures :
  1. Latency to delivery [ Time Frame: Time in days from randomization day to day of end of pregnancy ]

Secondary Outcome Measures :
  1. Cervical length [ Time Frame: within 24 hours of first tocolytic dose and at first week follow up ]
  2. Delivery prior to 37, 34 and 32 weeks [ Time Frame: after delivery ]
  3. Number of subsequent hospital admissions for preterm labor [ Time Frame: after delivery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01206998

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United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Juniper Pharmaceuticals, Inc.
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Principal Investigator: Tulin Ozcan, MD University of Rochester

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Responsible Party: Tulin Ozcan MD, MD, University of Rochester Identifier: NCT01206998     History of Changes
Other Study ID Numbers: VagPro 27515
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: October 1, 2012
Last Verified: September 2012

Keywords provided by Tulin Ozcan MD, University of Rochester:
preterm labor
cervical length

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