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

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.

Study Overview

• Status: Completed
• Conditions: Induced; Birth
• Intervention / Treatment: Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).

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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen L Wood, MD, FRCSC; Phone Number: 403-944-1438; Email: stephen.wood@ahs.ca
• Study Contact Backup: Name: Janice Skiffington, MSc; Phone Number: 403-944-8446; Email: janice.skiffington@ahs.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University Of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: oxytocin
Placebo Comparator: 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.	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.; Other Names: oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Cesarean section in labor	Rate of Cesarean section in labor	At Delivery
Occurrence of Uterine Hyperstimulation	Occurrence of >5 contractions in 10 minutes	During labour, after >=6 cm dilation
Proportion of screened subjects who agree to enroll in the trial	Proportion of screened subjects who agree to enroll in the trial	During screening of potential participants

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of perinatal death	Rate of perinatal death	At delivery
Rate of neonatal asphyxia	Neonatal asphyxia is defined as intrapartum stillbirth or neonatal death from asphyxia (Perinatal Society of Australia and New Zealand coding) or Neonatal Intensive Care Unit admission and at least two of: a. Apgar score of ≤5 at 10 minutes; b. Mechanical ventilation or chest compressions for resuscitation within 10 minutes; c. Cord pH < 7.00 (venous or arterial), or arterial base excess ≥ 12 at birth. Rate of neonatal asphyxia for deliveries involving primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	At delivery
Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling	Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling	At delivery
Rate of neonatal sepsis or suspected sepsis	Rate of neonatal sepsis or suspected sepsis	At delivery
Rate of postpartum hemorrhage	Rate of postpartum hemorrhage	At delivery
Rate of blood transfusion	Rate of blood transfusion	At delivery
Rate of postpartum uterine artery/pelvic artery embolization	Rate of postpartum uterine artery/pelvic artery embolization	Within 28 days of delivery
Rate of postpartum hysterectomy	Rate of postpartum hysterectomy	Within 28 days of delivery
Rate of postpartum maternal intensive care unit (ICU) admission	Rate of postpartum maternal intensive care unit (ICU) admission	At delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of oxytocin discontinuation	Duration of oxytocin discontinuation	During labour, after >=6 cm dilation
Rate of reintroduction of oxytocin infusion	Rate of reintroduction of oxytocin infusion	During labour, after >=6 cm dilation

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Stephen L Wood, MD, FRCSC, University Of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: oxytocin; Cesarean section; Obstetric Labor Complications; Induced labour
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: REB21-0614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No