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Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

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ClinicalTrials.gov Identifier: NCT00486824
Recruitment Status : Completed
First Posted : June 15, 2007
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Deirdre Judith Lyell, Stanford University

Tracking Information
First Submitted Date  ICMJE June 13, 2007
First Posted Date  ICMJE June 15, 2007
Results First Submitted Date  ICMJE August 31, 2018
Results First Posted Date  ICMJE October 1, 2018
Last Update Posted Date October 1, 2018
Actual Study Start Date  ICMJE April 2007
Actual Primary Completion Date December 8, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization [ Time Frame: Two weeks after enrolled and randomized, up to 37 weeks of pregnancy ]
Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00486824 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
  • Neonatal Birthweight [ Time Frame: Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery ]
    Birthweight is presented in grams
  • Gestational Age at Delivery [ Time Frame: Up to 42 weeks of pregnancy ]
  • Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery [ Time Frame: Up to 42 weeks of pregnancy ]
  • Count of Participants With Neonatal Morbidity [ Time Frame: Up to 42 weeks of pregnancy ]
    Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.
  • Count of Participants With Side-effect Due to the Medication [ Time Frame: Up to 42 weeks of pregnancy ]
    Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.
  • Time to Uterine Quiescence [ Time Frame: Up to 42 weeks of pregnancy ]
    Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Official Title  ICMJE Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial
Brief Summary

Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.

Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.

Detailed Description Patients presenting between 24-34 weeks gestation diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used. Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstetric Labor, Premature
Intervention  ICMJE
  • Drug: Indomethacin
    One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs.
  • Drug: Nifedipine
    Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.
Study Arms  ICMJE
  • Active Comparator: Indomethacin
    50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.
    Intervention: Drug: Indomethacin
  • Active Comparator: Nifedipine
    30 mg Nifedipine initially followed by 20 mg every 6 hrs for 48 hrs.
    Intervention: Drug: Nifedipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2018)
29
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 8, 2012
Actual Primary Completion Date December 8, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Singleton and twin gestations
  • Intact amniotic membranes
  • No contra-indications to tocolysis
  • 24-34 weeks gestation by last menstrual period and/or ultrasound
  • Documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement

Exclusion Criteria:

  • Ruptured amniotic membranes
  • Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
  • Non-reassuring fetal heart rate tracings
  • Contra-indications to indomethacin or nifedipine
  • Contra-indications to tocolysis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00486824
Other Study ID Numbers  ICMJE 97873
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deirdre Judith Lyell, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deirdre Judith Lyell Stanford University
PRS Account Stanford University
Verification Date August 2018

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