Clinical trial NCT05037617: The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction
Official title: The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Birth
Keywords: Obstetric Labor Complications
Cesarean section
Induced labour
oxytocin
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of Cesarean section in labor
timeFrame: At Delivery
measure: Occurrence of Uterine Hyperstimulation
timeFrame: During labour, after >=6 cm dilation
measure: Proportion of screened subjects who agree to enroll in the trial
timeFrame: During screening of potential participants
Secondary outcomes:
measure: Rate of perinatal death
timeFrame: At delivery
measure: Rate of neonatal asphyxia
timeFrame: At delivery
measure: Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling
timeFrame: At delivery
measure: Rate of neonatal sepsis or suspected sepsis
timeFrame: At delivery
measure: Rate of postpartum hemorrhage
timeFrame: At delivery
measure: Rate of blood transfusion
timeFrame: At delivery
measure: Rate of postpartum uterine artery/pelvic artery embolization
timeFrame: Within 28 days of delivery
measure: Rate of postpartum hysterectomy
timeFrame: Within 28 days of delivery
measure: Rate of postpartum maternal intensive care unit (ICU) admission
timeFrame: At delivery
Other outcomes:
measure: Duration of oxytocin discontinuation
timeFrame: During labour, after >=6 cm dilation
measure: Rate of reintroduction of oxytocin infusion
timeFrame: During labour, after >=6 cm dilation
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Stephen L Wood, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: