Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor (PAL)
Obstetric Labor, Premature
Drug: Micronized progesterone suppository
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor|
- Delivery before 37 weeks [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ] [ Designated as safety issue: No ]
- Delivery before 34 weeks [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ] [ Designated as safety issue: No ]Evaluated in women enrolled prior to 32 weeks gestation
- Delivery within 2 weeks of randomization [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Number of days pregnancy prolongation [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ] [ Designated as safety issue: No ]
- Infant birth weight [ Time Frame: Day of delivery in current pregnancy ] [ Designated as safety issue: No ]
- Neonatal intensive care unit admission [ Time Frame: Followed for duration of neonatal hospital stay, estimated maximum 16 weeks ] [ Designated as safety issue: No ]
- Chorioamnionitis [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ] [ Designated as safety issue: No ]
- Composite neonatal outcome [ Time Frame: Followed for duration of neonatal hospital stay, estimated maximum 16 weeks ] [ Designated as safety issue: No ]A composite neonatal outcome comprising neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, severe (grade III/IV) interventricular hemorrhage, necrotizing enterocolitis, and sepsis.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Micronized progesterone suppository
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
|Drug: Micronized progesterone suppository|
Placebo Comparator: Placebo suppository
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
RESEARCH DESIGN AND METHODS
The investigators will perform a randomized, blinded, placebo-controlled trial to evaluate the use of vaginal progesterone in women with arrested preterm labor after 24 weeks' gestation to reduce the risk of preterm birth before 37 weeks' gestation. Women enrolled in the study will be randomized to daily vaginal administration of progesterone (200 mg) or placebo from time of enrollment until 36 6/7 weeks' gestation. Women will be eligible if they have a singleton or twin gestation between 24 0/7 and 33 6/7 weeks' gestation and initially present with regular uterine contractions and a clinical diagnosis of preterm labor but remain undelivered without further cervical change 12 hours after discontinuation of acute tocolytic therapy. Women may also participate if it has been less than if they are considered eligible for discharge based on attending physician judgement prior to the 12 hour period of time.
Randomization and Blinding- Participants in the study will be randomized using a computer-generated randomization scheme with 1:1 allocation to receive progesterone or placebo. Investigators and research team members, participants, and the obstetric providers will be blinded to the allocated intervention.
- Data collection- Information will be recorded from the participant's medical record. Additional study information not included in the medical record will be obtained directly from the participant in an interview with the research team member.
- Follow-up- Regardless of whether the participant remains hospitalized or is discharged prior to delivery, she will meet with a study coordinator every 2 weeks. During the follow-up visit, a study team member will discuss compliance with the study drug and possible side effects. The participant will fill out a 1-page questionnaire that asks questions about compliance and side effects. This information will be recorded and provided to the Data Safety and Monitoring Board at the midpoint review.
SAMPLE SIZE ESTIMATION
The investigators plan to enroll 120 patients, with a 1:1 allocation to treatment and placebo. This sample size is adequate to detect a one-half reduction in the primary outcome, delivery before 37 weeks.
Baseline characteristics of women randomized to progesterone will be compared with women randomized to placebo. Rates of delivery before 37 weeks' gestation will be compared among the groups using the Chi-square test. Secondary outcomes will be evaluated using the Chi-square test for binary outcomes and the Student t-test for continuous outcomes. Length of time from enrollment to delivery will be analyzed using Kaplan-Meier curves and the Cox proportional hazards model. All analyses will be performed using the intention-to-treat principle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840228
|Contact: Molly J Stout, MD, MSCIemail@example.com|
|Contact: Mocica Anderson, RN, BSNfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine/ Barnes-Jewish Hospital||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Molly J Stout, MD, MSCI 314-362-8895 email@example.com|
|Contact: Monica Anderson, RN, BSN 314-747-1390 firstname.lastname@example.org|
|Principal Investigator: Heather A Frey, MD|
|Principal Investigator: George A Macones, MD, MSCE|
|Principal Investigator: Alison G Cahill, MD, MSCI|
|Principal Investigator: Molly J Stout, MD, MSCI|
|Study Chair:||George A Macones, MD, MSCE||Washington University School of Medicine|