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Oxytocin

Oxytocin Management for Induced Birth ((REDUCED-I) Trial)

N/A

Waitlist Available

Led By Stephen L Wood, MD, FRCSC

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 28 days of delivery

Awards & highlights

(REDUCED-I) Trial Summary

This trial is testing whether or not stopping oxytocin during labor will reduce the number of c-sections.

Who is the study for?

The REDUCED-I Pilot Trial is for first-time mothers who are at least 37 weeks pregnant with one baby in head-down position, undergoing labor induction with oxytocin. Women must be 18 or older. Those with multiple babies or known fetal anomalies cannot participate.Check my eligibility

What is being tested?

This trial tests whether stopping oxytocin after the active stage of labor begins (when dilation reaches at least 6 cm) can reduce the need for cesarean sections without increasing risks to mother and baby.See study design

What are the potential side effects?

Since this trial involves standard procedures already used during induced labor, side effects may include typical labor-related discomforts but aim to avoid complications like uterine hyperstimulation and fetal distress.

(REDUCED-I) Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

(REDUCED-I) Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Uterine Hyperstimulation

Proportion of screened subjects who agree to enroll in the trial

Rate of Cesarean section in labor

Secondary outcome measures

Rate of blood transfusion

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

Rate of neonatal asphyxia

+6 more

Other outcome measures

Duration of oxytocin discontinuation

Rate of reintroduction of oxytocin infusion

(REDUCED-I) Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention site (Foothills Medical Centre): Continuation of OxytocinExperimental Treatment1 Intervention

Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be >= 6 cm dilated.

Group II: Intervention site (Foothills Medical Centre): Discontinuation of oxytocinPlacebo Group1 Intervention

Participants in this arm will receive a blinded vial of saline solution once a patient is found to be >= 6 cm dilated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2021

N/A

~210

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

868,949 Total Patients Enrolled

Stephen L Wood, MD, FRCSCPrincipal InvestigatorUniversity of Calgary

Media Library

Continuation or Discontinuation of Oxytocin (Oxytocin) Clinical Trial Eligibility Overview. Trial Name: NCT05037617 — N/A

Induced Birth Research Study Groups: Intervention site (Foothills Medical Centre): Continuation of Oxytocin, Intervention site (Foothills Medical Centre): Discontinuation of oxytocin

Induced Birth Clinical Trial 2023: Continuation or Discontinuation of Oxytocin Highlights & Side Effects. Trial Name: NCT05037617 — N/A

Continuation or Discontinuation of Oxytocin (Oxytocin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05037617 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently recruiting volunteers for this trial?

"According to the information about this trial on clinicaltrials.gov, the study is presently looking for suitable candidates. It was initially published on October 25th 2021 and its details were most recently updated that same day."

Answered by AI

What objectives has this clinical trial been designed to fulfill?

"This clinical trial is set to assess the rate of Cesarean section during labour, following a dilation threshold of 6cm or more. Secondary outcomes being monitored include perinatal death, postpartum haemorrhage and neonatal asphyxia in primiparous women delivering at term (37 weeks gestation) with singleton vertex-presenting foetuses. The latter involves intrapartum stillbirths, neonatal mortality from asphyxiation or intensive care unit admissions coupled with Apgar scores lower than 5 after 10 minutes, mechanical ventilation/chest compressions for resuscitation within 10 minutes and cord pH"

Answered by AI

What is the most frequent application of continuing or halting oxytocin during active first stage labor (≥6 cm dilation)?

"Oxytocin can be administered or withheld to manage the labour process, including controlling haemorrhage, uterine contractions, and childbirth."

Answered by AI

How many subjects are being monitored within this research trial?

"Affirmative. Information on the clinicaltrials.gov website shows that this research is currently in search of participants, having been listed since October 25th 2021 with no updates to date. 200 individuals are needed from a single location for it's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stephen Wood 2021. "The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05037617.