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Hormone Therapy
Oxytocin Rest for Prolonged Labor (ORCA Trial)
N/A
Recruiting
Led By Matthew K Hoffman
Research Sponsored by Christiana Care Health Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Prolonged latent labor, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin
Must not have
Any contraindication to continuous oxytocin at time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to delivery
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if taking a break from oxytocin infusion for 60 minutes during prolonged labor can decrease the chances of cesarean delivery. This break, called 'oxytocin rest
Who is the study for?
This trial is for individuals experiencing prolonged labor or difficult childbirth, specifically when induction methods have failed. To participate, they must have been receiving continuous oxytocin without seeing progress in their labor.
What is being tested?
The study tests 'oxytocin rest,' which means stopping and then restarting oxytocin infusion after an hour to see if it reduces the need for cesarean delivery by improving uterine contractions and labor progress.
What are the potential side effects?
While not explicitly listed, potential side effects may include changes in contraction patterns or intensity, discomfort due to fluctuating labor progression, and possible impacts on fetal heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My labor was slow, with less than 6cm dilation after 8 hours of my water breaking and being on oxytocin.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot receive oxytocin due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of delivery to date of hospital discharge for neonate (or up to 28 days of life)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of delivery to date of hospital discharge for neonate (or up to 28 days of life)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cesarean rate
Secondary study objectives
Composite maternal adverse outcome
Composite neonatal adverse outcome
Duration of active labor (hours)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 60-minute oxytocin restExperimental Treatment1 Intervention
Group II: Usual care with continuous oxytocin infusionActive Control1 Intervention
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Who is running the clinical trial?
Christiana Care Health ServicesLead Sponsor
116 Previous Clinical Trials
106,890 Total Patients Enrolled
1 Trials studying Labor Dystocia
80 Patients Enrolled for Labor Dystocia
Matthew K HoffmanPrincipal InvestigatorChristiana Care Health Services
Teresa C LoguePrincipal InvestigatorChristiana Care Health Services
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