The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    200
  • sponsor
    University of Calgary
Updated on 8 November 2021
Accepts healthy volunteers

Summary

This pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (6 cm dilation). The intent is to reduce uterine hyperstimulation and fetal distress, therefore, lowering cesarean sections (CS) in first time mothers at term ( 37 weeks), with a cephalic presenting singleton fetus, without increasing maternal or neonatal morbidity. If REDUCE-I pilot trial suggests a safe reduction in CS rates and patient satisfaction, application for a multi-centre randomized controlled trial would follow.

Description

This pilot project is a randomized controlled trial of a proposed intervention to modify management of labor inductions once in the active first stage of labor. The intervention will take place at Foothills Medical Centre (FMC). Randomization will be computer generated, participants will be stratified by need for cervical ripening and randomization will be blocked. Participants will be primiparous women 18 years old or older, at term ( 37 weeks) with a cephalic presenting singelton fetus undergoing induction of labor with oxytocin. Once patients are in the active first stage of labor, study medication will be initiated (identical vials of oxytocin or saline prepared by the Alberta Health Services Research Pharmacy). Treatment period will continue until delivery. If the frequency of contractions are reduced to less than 2 in 10 minutes or there has been no change in dilation for 4 hours, then oxytocin can be restarted.

Royal Alexandra Hospital in Edmonton will be used as a contemporaneous non-intervention control site.

Details
Condition Induced; Birth
Treatment Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).
Clinical Study IdentifierNCT05037617
SponsorUniversity of Calgary
Last Modified on8 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

pregnant women undergoing induction of labor with oxytocin
Primiparous
years old or older
at term (37 weeks)
cephalic presenting
singleton fetus

Exclusion Criteria

Multiple pregnancies
known fetal congenital or chromosomal anomalies
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