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Hormone Therapy

60-minute oxytocin rest for Labor Dystocia (ORCA Trial)

Q: Are there any available vacancies for patient participation in this clinical trial?

As per the details available on clinicaltrials.gov, this investigation is currently actively seeking participants. It was initially disclosed on February 15th, 2024, and last revised on February 13th of the same year.

Q: What is the upper limit for the number of individuals participating in this clinical investigation?

Indeed, details on clinicaltrials.gov highlight the ongoing patient recruitment for this particular investigation. The trial was initially listed on February 15th, 2024 and last modified on February 13th, 2024. A total of 350 individuals are being sought at a single designated location.

Q: Is the research trial open to participants younger than 60 years of age?

Individuals aged between 18 and 55 are eligible to apply for this research endeavor. It is noteworthy that there are three ongoing clinical trials designated for minors below the age of legal adulthood, while eight studies cater specifically to individuals above 65 years old.

N/A

Recruiting

Led By Teresa C Logue

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to delivery

Awards & highlights

ORCA Trial 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.Check my eligibility

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.See study design

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.

ORCA 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.

Select...

My labor was slow, with less than 6cm dilation after 8 hours of my water breaking and being on oxytocin.

ORCA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 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

Cesarean rate

Secondary outcome measures

Composite maternal adverse outcome

Composite neonatal adverse outcome

Duration of active labor (hours)

+7 more

Side effects data

From 2020 Phase 2 trial • 42 Patients • NCT03016598

Constipation

Stinging sensation

100%

80%

60%

40%

20%

Study treatment Arm

Oxytocin

Placebo

ORCA 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Christiana Care Health ServicesLead Sponsor

115 Previous Clinical Trials

105,301 Total Patients Enrolled

1 Trials studying Labor Dystocia

80 Patients Enrolled for Labor Dystocia

Teresa C LoguePrincipal InvestigatorChristiana Care Health Services

Matthew K HoffmanPrincipal InvestigatorChristiana Care Health Services

Frequently Asked Questions

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

Are there any available vacancies for patient participation in this clinical trial?

"As per the details available on clinicaltrials.gov, this investigation is currently actively seeking participants. It was initially disclosed on February 15th, 2024, and last revised on February 13th of the same year."

Answered by AI

What is the upper limit for the number of individuals participating in this clinical investigation?

"Indeed, details on clinicaltrials.gov highlight the ongoing patient recruitment for this particular investigation. The trial was initially listed on February 15th, 2024 and last modified on February 13th, 2024. A total of 350 individuals are being sought at a single designated location."

Answered by AI

Is the research trial open to participants younger than 60 years of age?

"Individuals aged between 18 and 55 are eligible to apply for this research endeavor. It is noteworthy that there are three ongoing clinical trials designated for minors below the age of legal adulthood, while eight studies cater specifically to individuals above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oxytocin Rest to Reduce Cesarean Delivery

2024. "Oxytocin Rest to Reduce Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268431.

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