Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00486824
First received: June 13, 2007
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Obstetric Labor, Premature
Drug: Indomethacin
Drug: Nifedipine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Recurrent preterm labor within two weeks of randomization [ Time Frame: Two weeks after enrolled and randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Birth weight, gestational age, delay of delivery, neonatal morbidities, maternal side effects, time to uterine quiescence [ Time Frame: Discharge of mother and neonate ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: April 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Indomethacin
50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.
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.
Active Comparator: Nifedipine
30 mg Nifedipine initially followed by 10 mg 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486824

Contacts
Contact: Deirdre J Lyell, MD (650) 736-1191 dlyell@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Deirdre J Lyell, MD    650-736-1191    dlyell@stanford.edu   
Contact: Yair Blumenfeld, MD    (650) 269-4665    yairb@stanford.edu   
Principal Investigator: Deirdre Judith Lyell         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Deirdre Judith Lyell Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00486824     History of Changes
Other Study ID Numbers: 97873
Study First Received: June 13, 2007
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Indomethacin
Nifedipine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014