Nifedipine Compared to Atosiban for Treating Preterm Labor
This study has been completed.
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
First received: January 8, 2008
Last updated: March 12, 2012
Last verified: March 2012
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.|
Resource links provided by NLM:
Further study details as provided by HaEmek Medical Center, Israel:
Primary Outcome Measures:
- delaying labor [ Time Frame: for more than 48 hours after starting treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- drugs side effects [ Time Frame: within the first 48 hours after treatment ] [ Designated as safety issue: Yes ]
- obstetrical (number of days to delivery, gestational age at delivery, mode of delivery) [ Time Frame: within 24 hours after delivery ] [ Designated as safety issue: No ]
- neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH) [ Time Frame: within 30 days from delivery ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
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.
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