NCT00599898

Nifedipine Compared to Atosiban for Treating Preterm Labor

Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Raed Salim · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.

Conditions

• Labor, Premature

Interventions

Type	Name	Description
DRUG	Atosiban	Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
DRUG	Nifedipine	Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2008-01-24
• Last updated: 2012-03-13

Locations

1 site across 1 country: Israel