Vaginal Progesterone as a Treatment for Women Active Preterm Labor

NCT01206998 | Withdrawn DMC

• 1 other identifier: VagPro 27515
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor, Premature

Keywords

preterm labor; progesterone; tocolysis; cervical length

Outcome Measures

Primary Outcomes (1)

• Latency to delivery

  Time in days from randomization day to day of end of pregnancy

Secondary Outcomes (3)

• 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

Study Arms (2)

Vaginal progesterone gel

EXPERIMENTAL

Drug: Vaginal progesterone gel

Placebo vaginal gel

PLACEBO COMPARATOR

Drug: Placebo vaginal gel

Interventions

Vaginal progesterone gel DRUG

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

Also known as: Prochieve® 8%/Crinone 8%®

Vaginal progesterone gel

Placebo vaginal gel DRUG

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

Also known as: Replens®

Placebo vaginal gel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Juniper Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Progesterone; Replens

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Tulin Ozcan, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 22, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

US (1)