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Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor (PAL)

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ClinicalTrials.gov Identifier: NCT01840228
Recruitment Status : Terminated (Low enrollment rate)
First Posted : April 25, 2013
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Washington University School of Medicine

April 17, 2013
April 25, 2013
October 3, 2018
May 2013
May 7, 2018   (Final data collection date for primary outcome measure)
Delivery before 37 weeks [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ]
Same as current
Complete list of historical versions of study NCT01840228 on ClinicalTrials.gov Archive Site
  • Delivery before 34 weeks [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ]
    Evaluated in women enrolled prior to 32 weeks gestation
  • Delivery within 2 weeks of randomization [ Time Frame: 2 weeks ]
  • Number of days pregnancy prolongation [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ]
  • Infant birth weight [ Time Frame: Day of delivery in current pregnancy ]
  • Neonatal intensive care unit admission [ Time Frame: Followed for duration of neonatal hospital stay, estimated maximum 16 weeks ]
  • Chorioamnionitis [ Time Frame: Duration of current pregnancy, anticipated maximum 18 weeks ]
  • Composite neonatal outcome [ Time Frame: Followed for duration of neonatal hospital stay, estimated maximum 16 weeks ]
    A composite neonatal outcome comprising neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, severe (grade III/IV) interventricular hemorrhage, necrotizing enterocolitis, and sepsis.
Same as current
Not Provided
Not Provided
 
Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. However, current use of this therapy is limited to certain high-risk groups including women with a history of preterm birth and women with a short cervix. This study seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women with arrested preterm labor. The investigators hypothesize that administration of vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours after cessation of short-term therapy to inhibit contractions will result in lower rates of preterm birth before 37 weeks' than will administration of placebo.

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.

Procedures-

  • 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.

STATISTICAL ANALYSIS

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Premature Birth
  • Obstetric Labor, Premature
Drug: Micronized progesterone suppository
  • Active Comparator: Micronized progesterone suppository
    Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
    Intervention: Drug: Micronized progesterone suppository
  • Placebo Comparator: Placebo suppository
    One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
    Intervention: Drug: Micronized progesterone suppository

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
38
240
May 7, 2018
May 7, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Singleton or twin gestation
  • Estimated gestational age between 24 0/7 and 33 6/7 weeks' gestation
  • Initially present with regular contractions and clinical diagnosis of preterm labor but remain undelivered with 1) no further cervical change 12 hours after discontinuation of acute tocolytic therapy; or 2) be considered eligible for discharge based on attending physician judgment prior to the 12 hour period of time
  • The participant's cervix must be at least 1 cm at the time of enrollment

Exclusion Criteria:

  • Non-English speaking
  • Rupture of membranes
  • Chorioamnionitis
  • Non-reassuring fetal status
  • Maternal indication for delivery
  • Placental abruption
  • Intrauterine fetal demise
  • Prenatally diagnosed major fetal anomaly
  • Cervical cerclage in place
  • Previous administration of progesterone during the current pregnancy for a history of preterm birth or short cervix
  • Participant is either unwilling or unable to attend follow-up study visits following hospital discharge
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01840228
201301148
Yes
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Thrasher Research Fund
Study Chair: George A Macones, MD, MSCE Washington University School of Medicine
Principal Investigator: Heather A Frey, MD, MSCI Ohio State University
Washington University School of Medicine
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP