The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction
- Conditions
- Induced; Birth
- Interventions
- Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).
- Registration Number
- NCT05037617
- Lead Sponsor
- University of Calgary
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 205
- pregnant women undergoing induction of labor with oxytocin.
- Primiparous
- 18 years old or older
- at term (≥37 weeks)
- cephalic presenting
- singleton fetus
- Multiple pregnancies
- known fetal congenital or chromosomal anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention site (Foothills Medical Centre): Continuation of Oxytocin Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be \>= 6 cm dilated. Intervention site (Foothills Medical Centre): Discontinuation of oxytocin Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). Participants in this arm will receive a blinded vial of saline solution once a patient is found to be \>= 6 cm dilated.
- Primary Outcome Measures
Name Time Method Rate of Cesarean section in labor At Delivery Rate of Cesarean section in labor
Occurrence of Uterine Hyperstimulation During labour, after >=6 cm dilation Occurrence of \>5 contractions in 10 minutes
Proportion of screened subjects who agree to enroll in the trial During screening of potential participants Proportion of screened subjects who agree to enroll in the trial
- Secondary Outcome Measures
Name Time Method Rate of postpartum hemorrhage At delivery Rate of postpartum hemorrhage
Rate of postpartum uterine artery/pelvic artery embolization Within 28 days of delivery Rate of postpartum uterine artery/pelvic artery embolization
Rate of postpartum hysterectomy Within 28 days of delivery Rate of postpartum hysterectomy
Rate of postpartum maternal intensive care unit (ICU) admission At delivery Rate of postpartum maternal intensive care unit (ICU) admission
Rate of perinatal death At delivery Rate of perinatal death
Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling At delivery Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling
Rate of neonatal asphyxia At delivery 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
Rate of neonatal sepsis or suspected sepsis At delivery Rate of neonatal sepsis or suspected sepsis
Rate of blood transfusion At delivery Rate of blood transfusion
Trial Locations
- Locations (1)
University of Calgary
🇨🇦Calgary, Alberta, Canada