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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
205
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.
University of Calgary
Calgary, Alberta, Canada
Rate of Cesarean section in labor
Rate of Cesarean section in labor
Time frame: At Delivery
Occurrence of Uterine Hyperstimulation
Occurrence of \>5 contractions in 10 minutes
Time frame: 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
Time frame: During screening of potential participants
Rate of perinatal death
Rate of perinatal death
Time frame: 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
Time frame: 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
Time frame: At delivery
Rate of neonatal sepsis or suspected sepsis
Rate of neonatal sepsis or suspected sepsis
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Time frame: At delivery
Rate of postpartum hemorrhage
Rate of postpartum hemorrhage
Time frame: At delivery
Rate of blood transfusion
Rate of blood transfusion
Time frame: At delivery
Rate of postpartum uterine artery/pelvic artery embolization
Rate of postpartum uterine artery/pelvic artery embolization
Time frame: Within 28 days of delivery
Rate of postpartum hysterectomy
Rate of postpartum hysterectomy
Time frame: Within 28 days of delivery
Rate of postpartum maternal intensive care unit (ICU) admission
Rate of postpartum maternal intensive care unit (ICU) admission
Time frame: At delivery