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

NCT ID: NCT05037617

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2024-02-15

Brief 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.

Detailed 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.

Conditions

Induced; Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention site (Foothills Medical Centre): Continuation of Oxytocin

Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be \>= 6 cm dilated.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Intervention site (Foothills Medical Centre): Discontinuation of oxytocin

Participants in this arm will receive a blinded vial of saline solution once a patient is found to be \>= 6 cm dilated.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

oxytocin

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Multiple pregnancies
• known fetal congenital or chromosomal anomalies

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Stephen Wood

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen L Wood, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REB21-0614

Identifier Type: -

Identifier Source: org_study_id