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

University of Calgary

Status: Completed

Conditions: Induced; Birth

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05037617

REB21-0614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 2 patient groups, including a placebo group

Intervention site (Foothills Medical Centre): Continuation of Oxytocin

Experimental group

Description:

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

Treatment:

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 group

Description:

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

Treatment:

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