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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 belowSelect...
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
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 moreOther 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
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
795 Previous Clinical Trials
874,374 Total Patients Enrolled
Stephen L Wood, MD, FRCSCPrincipal InvestigatorUniversity of Calgary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The pregnancy involves only one fetus.You are pregnant with more than one baby.I am 18 years old or older.My unborn baby has been diagnosed with a genetic or chromosomal condition.You have not given birth before.The baby is positioned head first in the womb.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention site (Foothills Medical Centre): Continuation of Oxytocin
- Group 2: Intervention site (Foothills Medical Centre): Discontinuation of oxytocin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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