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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: | Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study |
| 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 2011 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria::
Exclusion Criteria:- Ruptured amniotic membranes
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: | Stanford University School of Medicine ( Deirdre Judith Lyell ) |
| Study ID Numbers: | 97873 |
| Study First Received: | June 13, 2007 |
| Last Updated: | February 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00486824 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Anti-Inflammatory Agents Vasodilator Agents Pregnancy Complications Molecular Mechanisms of Pharmacological Action Obstetric Labor, Premature Physiological Effects of Drugs Calcium Channel Blockers Reproductive Control Agents Gout Suppressants Nifedipine Membrane Transport Modulators Tocolytic Agents Sensory System Agents |
Therapeutic Uses Indomethacin Anti-Inflammatory Agents, Non-Steroidal Analgesics Cyclooxygenase Inhibitors Obstetric Labor Complications Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |