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| Sponsor: | Stanford University |
|---|---|
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00486824 |
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 and 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 |
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Indomethacin |
Drug: Indomethacin and Nifedipine
50 mg oral indomethacin with two pills of placebo, vs 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The maintenance dose for each arm will comprise either 25 mg of oral indomethacin taken every 6 hours for 48 hours, or 20 mg of oral nifedipine taken every 6 hours for 48 hours.
|
| Active Comparator: Nifedipine |
Drug: Indomethacin and Nifedipine
50 mg oral indomethacin with two pills of placebo, vs 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The maintenance dose for each arm will comprise either 25 mg of oral indomethacin taken every 6 hours for 48 hours, or 20 mg of oral nifedipine taken every 6 hours for 48 hours.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Deirdre J Lyell, MD | (650) 736-1191 | dlyell@stanford.edu |
| 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 | |
| Principal Investigator: | Deirdre Judith Lyell | Stanford University |
More Information
| Responsible Party: | Deirdre Judith Lyell, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00486824 History of Changes |
| Other Study ID Numbers: | 97873 |
| Study First Received: | June 13, 2007 |
| Last Updated: | June 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Indomethacin Nifedipine Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents |