Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00486824 · ClinicalTrials.gov registry record · Phase 1
Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00486824: Completed Phase 1 study, sponsored by Stanford University.
NCT00486824 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00486824, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study 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.
Interventions
- DRUG Indomethacin
- DRUG Nifedipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-04 |
| Est. Completion | 2012-12-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00486824
The ClinicalTrials.gov registry entry for NCT00486824 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Indomethacin is the first listed.
NCT00486824 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00486824 about?
NCT00486824 is a clinical study titled "Indomethacin Versus Nifedipine for Preterm Labor Tocolysis". 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...
What is the current status of trial NCT00486824?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-04. Estimated completion is 2012-12-08.
What interventions are being tested in trial NCT00486824?
The interventions under investigation include: Indomethacin (DRUG), Nifedipine (DRUG).
Who is sponsoring clinical trial NCT00486824?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.