Labor, Premature Clinical Trial
— VagProOfficial title:
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Strong Memorial Hospital | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Juniper Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Latency to delivery | Time in days from randomization day to day of end of pregnancy | No | |
Secondary | Cervical length | within 24 hours of first tocolytic dose and at first week follow up | No | |
Secondary | Delivery prior to 37, 34 and 32 weeks | after delivery | No | |
Secondary | Number of subsequent hospital admissions for preterm labor | after delivery | No |
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