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

Induced; Birth Clinical Trial

— (REDUCED-I)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037617
• Other study ID #: REB21-0614
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: February 15, 2024

Study information

• Verified date: March 2024
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Induced; Birth

Intervention

Drug:
• Continuation 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of oxytocin discontinuation	Duration of oxytocin discontinuation	During labour, after >=6 cm dilation
Other	Rate of reintroduction of oxytocin infusion	Rate of reintroduction of oxytocin infusion	During labour, after >=6 cm dilation
Primary	Rate of Cesarean section in labor	Rate of Cesarean section in labor	At Delivery
Primary	Occurrence of Uterine Hyperstimulation	Occurrence of >5 contractions in 10 minutes	During labour, after >=6 cm dilation
Primary	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	Rate of perinatal death	Rate of perinatal death	At delivery
Secondary	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
Secondary	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
Secondary	Rate of neonatal sepsis or suspected sepsis	Rate of neonatal sepsis or suspected sepsis	At delivery
Secondary	Rate of postpartum hemorrhage	Rate of postpartum hemorrhage	At delivery
Secondary	Rate of blood transfusion	Rate of blood transfusion	At delivery
Secondary	Rate of postpartum uterine artery/pelvic artery embolization	Rate of postpartum uterine artery/pelvic artery embolization	Within 28 days of delivery
Secondary	Rate of postpartum hysterectomy	Rate of postpartum hysterectomy	Within 28 days of delivery
Secondary	Rate of postpartum maternal intensive care unit (ICU) admission	Rate of postpartum maternal intensive care unit (ICU) admission	At delivery