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

NCT05037617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2024-03-26

No results posted yet for this study

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.

Conditions

  • Induced; Birth

Interventions

DRUG

Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).

At the intervention site (Foothills Medical Centre), for participants who consent to being part of the trial, once a patient is found to be \>= 6 cm dilation, the study medication will be initiated. Pharmacy will make up identical vials of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician. The intervention will be continued until delivery unless contractions decrease to less than 2 in 10 minutes or if no further cervical dilation is noted 4 hours after discontinuation.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Stephen L Wood, MD, FRCSC · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2024-02-15
Completion
2024-02-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037617 on ClinicalTrials.gov