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

NCT05037617 | Completed

• 1 other identifier: REB21-0614
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced; Birth

Keywords

Obstetric Labor Complications; Cesarean section; Induced labour; oxytocin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Rate of perinatal death

  At delivery

• Rate of neonatal asphyxia

  At delivery

• Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling

  At delivery

• Rate of neonatal sepsis or suspected sepsis

  At delivery

• Rate of postpartum hemorrhage

  At delivery

Other Outcomes (2)

• Duration of oxytocin discontinuation

  During labour, after >=6 cm dilation

• Rate of reintroduction of oxytocin infusion

  During labour, after >=6 cm dilation

Study Arms (2)

Intervention site (Foothills Medical Centre): Continuation of Oxytocin

EXPERIMENTAL

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).

Intervention site (Foothills Medical Centre): Discontinuation of oxytocin

PLACEBO COMPARATOR

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).

Interventions

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

Also known as: oxytocin

Intervention site (Foothills Medical Centre): Continuation of Oxytocin; Intervention site (Foothills Medical Centre): Discontinuation of oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Multiple pregnancies
• known fetal congenital or chromosomal anomalies

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

Dilatation; Oxytocin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Stephen L Wood, MD, FRCSC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. Nurses will use the blinded vials for ongoing infusion. Patients and caregivers will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Once a patient is found to be \>=6 cm dilation, the patient will received a blinded vial of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 8, 2021
• Study Start: October 25, 2021
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)