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NCT00811057 · ClinicalTrials.gov registry record · NA
Tocolysis for Preterm Labor
A NA study, sponsored by University of Mississippi Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 301
- Enrollment target
NCT00811057 is a NA study that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 301 participants.
The verdict
NCT00811057, a NA study, has completed, sponsored by University of Mississippi Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 301 participants
- Enrollment target
Study Summary
Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of all practitioners, but recent data suggest magnesium given this way may be harmful for the baby's future development. Other drugs such as antiprostaglandin agents are very effective in stopping uterine activity, but particularly when used for \>48 hours have been associated with both maternal and fetal sides effects. Lastly, calcium channel antagonists are effective in stopping contractions and have very little in the way of maternal and fetal side effects, but less data is available in the United States on their use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping preterm labor. The primary outcomes will be to see which agent stops the uterine contractions most effectively, for the longest period of time with fewest relapses and results in significant prolongation of pregnancy. If one of these agents is clearly superior to the other two it would help women avoid early delivery or have significant extension of their pregnancy to avoid some of the complications of preterm birth in the baby.
Interventions
- DRUG Indomethacin
- DRUG Nifedipine
- DRUG 1 Magnesium Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2004-06 |
| Est. Completion | 2010-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00811057
The ClinicalTrials.gov registry entry for NCT00811057 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Mississippi Medical Center, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Indomethacin is the first listed.
NCT00811057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00811057 about?
NCT00811057 is a clinical study titled "Tocolysis for Preterm Labor". Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of a...
What is the current status of trial NCT00811057?
This trial is currently completed. It is a NA study. The enrollment target is 301 participants. The study started on 2004-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00811057?
The interventions under investigation include: Indomethacin (DRUG), Nifedipine (DRUG), 1 Magnesium Sulfate (DRUG).
Who is sponsoring clinical trial NCT00811057?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
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