Tocolysis for Preterm Labor

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Mississippi Medical Center
• Treatments: Indomethacin; Magnesium Sulfate; Nifedipine

Criteria

Inclusion Criteria:

• Pregnancies with intact membranes in confirmed preterm labor;

• 20 - 32 weeks' gestation;

• Cervical dilatation 0 - 3cm versus 4 - 6cm;

• No conditions contraindicating continued pregnancy (severe IUGR, chorioamnionitis, non-reassuring fetal tracing - physician judgement); AND

• Able and willing to consent to the study protocol.

Exclusion Criteria:

• Failure to meet admission criteria;

• Known serious fetal malformations;

• Severe maternal/obstetric disease affecting the mother or fetus (severe cardiac disease, placental abruption/previa, severe diabetes, severe preeclampsia, etc. - physician judgment);

• Allergic to magnesium, antiprostaglandin or calcium channel antagonist;

• Refusal or inability to consent to the study