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N/A N=301 Randomized Treatment

Tocolysis for Preterm Labor

Preterm Labor

Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor. — 31.2; 31.8; 31.8 weeks

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
1 Magnesium Sulfate (Drug); Nifedipine (Drug); Indomethacin (Drug)
Age
Pediatric, Adult · 16+ yrs
Sex
Female
Sponsor
University of Mississippi Medical Center
Primary completion
Jun 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.
31.2; 31.8; 31.8
SECONDARY
The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery
22.5; 21.7; 22.7

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00811057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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