Induced; Birth
Conditions
Keywords
Obstetric Labor Complications, Cesarean section, Induced labour, oxytocin
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.
Interventions
DRUGContinuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).
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.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of Cesarean section in labor | At Delivery | Rate of Cesarean section in labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 sepsis or suspected sepsis | At delivery | Rate of neonatal sepsis or suspected sepsis |
| 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 blood transfusion | At delivery | Rate of blood transfusion |
| Rate of perinatal death | At delivery | Rate of perinatal death |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of oxytocin discontinuation | During labour, after >=6 cm dilation | Duration of oxytocin discontinuation |
| Rate of reintroduction of oxytocin infusion | During labour, after >=6 cm dilation | Rate of reintroduction of oxytocin infusion |
Countries
Canada
Outcome results
None listed