Oxytocin Rest to Reduce Cesarean Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorChristiana Care Health Services
About this trial
Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.
The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
Singleton gestation in vertex presentation
≥36 weeks gestation
Prolonged latent labor, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin
Disqualifiers
Not meeting the above criteria
Any contraindication to continuous oxytocin at time of randomization
Cesarean section anticipated by the clinical team at time of randomization (for any reason excepting labor dystocia)
>18 hours between rupture of membranes and randomization
Trial design
Design model
Parallel
Treatments tested in this trial
Oxytocin rest
Other intervention60-minute oxytocin rest
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: 60-minute oxytocin restExperimental treatment 1 intervention
Group B: Usual care with continuous oxytocin infusionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cesarean rate
Number of participants delivered by cesarean
Time frame
At time of deliverySecondary outcomes
1
Time to delivery (hours)
defined as time from enrollment to delivery time, regardless of mode of delivery
Time frame
From randomization to delivery2
Time to vaginal delivery (hours)
defined as time from enrollment to delivery time, for patients with vaginal delivery (cesarean delivery censored)
Time frame
From randomization to delivery3
Time to active labor (hours)
defined as time from enrollment to first exam with cervical dilation ≥6cm (cesarean delivery at \<6cm dilation censored)
Time frame
From randomization to delivery4
Duration of active labor (hours)
defined as time from first exam with cervical dilation ≥6cm to delivery time (cesarean delivery censored)
Time frame
From randomization to deliverySponsors and contacts
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Source ClinicalTrials.gov