drugset / Trial / NCT00811057

Tocolysis for Preterm Labor

NCT00811057

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-06
Primary completion
2009-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Indomethacin Small molecule 25 mg Rectal
Comparator Indomethacin Small molecule 50 mg Rectal
Comparator Magnesium Sulfate Other / unclassified 2 g Intravenous
Comparator Magnesium Sulfate Other / unclassified 4 g Intravenous
Comparator Nifedipine Other / unclassified 10 mg Oral
Comparator Nifedipine Other / unclassified 20 mg Oral

Indications

No indication recorded.