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

University of Calgary, Calgary, Canada
Induced BirthContinuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). - Drug
Eligibility
18+
Female
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Study Summary

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Within 28 days of delivery

At Delivery
Rate of Cesarean section in labor
At delivery
Rate of blood transfusion
Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling
Rate of neonatal asphyxia
Rate of neonatal sepsis or suspected sepsis
Rate of perinatal death
Postpartum Hemorrhage
Rate of postpartum maternal intensive care unit (ICU) admission
At least one month after delivery
Patient satisfaction
During labour, after >=6 cm dilation
Duration of oxytocin discontinuation
Occurrence of Uterine Hyperstimulation
Rate of reintroduction of oxytocin infusion
During screening of potential participants
Proportion of screened subjects who agree to enroll in the trial
Day 28
Rate of postpartum hysterectomy
Rate of postpartum uterine artery/pelvic artery embolization

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Intervention site (Foothills Medical Centre): Continuation of Oxytocin
1 of 2
Intervention site (Foothills Medical Centre): Discontinuation of oxytocin
1 of 2

Experimental Treatment

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). · Has Placebo Group · N/A

Intervention site (Foothills Medical Centre): Continuation of Oxytocin
Drug
Experimental Group · 1 Intervention: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). · Intervention Types: Drug
Intervention site (Foothills Medical Centre): Discontinuation of oxytocin
Drug
PlaceboComparator Group · 1 Intervention: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 28 days of delivery

Who is running the clinical trial?

University of CalgaryLead Sponsor
728 Previous Clinical Trials
573,458 Total Patients Enrolled
Stephen L Wood, MD, FRCSCPrincipal InvestigatorUniversity of Calgary

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not given birth before.
The baby is positioned head first in the womb.
The pregnancy involves only one fetus.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.