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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction

Conditions
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Induced; Birth

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention site (Foothills Medical Centre): Continuation of Oxytocin<br>Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be >= 6 cm dilated. | Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).<br>* 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.<br>* Other names: oxytocin;|
| Placebo Comparator: Intervention site (Foothills Medical Centre): Discontinuation of oxytocin<br>Participants in this arm will receive a blinded vial of saline solution once a patient is found to be >= 6 cm dilated. | Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).<br>* 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.<br>* Other names: oxytocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cesarean section in labor | Rate of Cesarean section in labor | At Delivery | 
| Occurrence of Uterine Hyperstimulation | Occurrence of >5 contractions in 10 minutes | 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 | During screening of potential participants | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perinatal death | Rate of perinatal death | 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 | 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 | At delivery | 
| Rate of neonatal sepsis or suspected sepsis | Rate of neonatal sepsis or suspected sepsis | At delivery | 
| Rate of postpartum hemorrhage | Rate of postpartum hemorrhage | At delivery | 
| Rate of blood transfusion | Rate of blood transfusion | At delivery | 
| Rate of postpartum uterine artery/pelvic artery embolization | Rate of postpartum uterine artery/pelvic artery embolization | Within 28 days of delivery | 
| Rate of postpartum hysterectomy | Rate of postpartum hysterectomy | Within 28 days of delivery | 
| Rate of postpartum maternal intensive care unit (ICU) admission | Rate of postpartum maternal intensive care unit (ICU) admission | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstetric Labor Complications, Cesarean section, Induced labour, oxytocin