Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

• Status: Terminated
• Trial end date: 2019-10-10
• Target enrollment: 0
• Participant gender: Female

Summary

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Indomethacin; Nifedipine

Criteria

Inclusion Criteria:

• We will include pregnant women between 220/7 to 316/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:

• cervical change or

• 2 cm dilated or

• positive fetal fibronectin or

• transvaginal cervical length <2.5 cm

Exclusion Criteria:

• We will exclude pregnant women with any contraindication to tocolysis:

• clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)

• non reassuring fetal heart tones

• suspected placental abruption

• preterm premature rupture of membranes

• prior tocolytic treatment during their pregnancy

• known adverse effect to indomethacin or nifedipine