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Completed

NCT Number: NCT05037617

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

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.

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Key information

Conditions

Induced; Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).

Drug

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.

Other names: oxytocin

Primary outcomes

  1. Rate of Cesarean section in labor

    Time frame: At Delivery

    Rate of Cesarean section in labor

  2. Occurrence of Uterine Hyperstimulation

    Time frame: During labour, after >=6 cm dilation

    Occurrence of >5 contractions in 10 minutes

  3. Proportion of screened subjects who agree to enroll in the trial

    Time frame: During screening of potential participants

    Proportion of screened subjects who agree to enroll in the trial

Secondary outcomes

  1. Rate of perinatal death

    Time frame: At delivery

    Rate of perinatal death

  2. Rate of neonatal asphyxia

    Time frame: 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

  3. Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling

    Time frame: At delivery

    Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling

  4. Rate of neonatal sepsis or suspected sepsis

    Time frame: At delivery

    Rate of neonatal sepsis or suspected sepsis

  5. Rate of postpartum hemorrhage

    Time frame: At delivery

    Rate of postpartum hemorrhage

  6. Rate of blood transfusion

    Time frame: At delivery

    Rate of blood transfusion

  7. Rate of postpartum uterine artery/pelvic artery embolization

    Time frame: Within 28 days of delivery

    Rate of postpartum uterine artery/pelvic artery embolization

  8. Rate of postpartum hysterectomy

    Time frame: Within 28 days of delivery

    Rate of postpartum hysterectomy

  9. Rate of postpartum maternal intensive care unit (ICU) admission

    Time frame: At delivery

    Rate of postpartum maternal intensive care unit (ICU) admission

Other outcomes

  1. Duration of oxytocin discontinuation

    Time frame: During labour, after >=6 cm dilation

    Duration of oxytocin discontinuation

  2. Rate of reintroduction of oxytocin infusion

    Time frame: During labour, after >=6 cm dilation

    Rate of reintroduction of oxytocin infusion

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: (REDUCED-I)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2021
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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