Prolonged LaborORCANCT06268431
Oxytocin Rest to Reduce Cesarean Delivery
A study testing Oxytocin rest in people with Prolonged Labor and Failed Induction, run by Christiana Care Health Services at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Prolonged Labor, Failed Induction, Labor Dystocia
- What is being tested?
- Oxytocin rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ≥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
Who cannot join
- 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
- Known intraamniotic infection at randomization
- Fetal demise
- Any contraindication to vaginal delivery
- Maternal eclampsia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ChristianaCare Health System
Newark, Delaware, 19718
Teresa C Logue, 302-733-6563, teresa.logue@christianacare.org
About this study
Official title: Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Randomized Controlled 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.
Read the detailed description
This open-label randomized trial of consenting pregnant people with prolonged latent labor aims to determine whether 60-minute oxytocin rest reduces risk for cesarean when compared to continuous oxytocin infusion. As secondary aims, this trial will also assess the impact of 60-minute oxytocin rest on: measures of the length of labor, risk for adverse maternal and neonatal outcomes, and measures of patient autonomy and sense of control.
The investigators will enroll 350 patients with singleton pregnancies at ≥36 weeks gestation with prolonged labor in the latent phase, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin. Both nulliparous and multiparous individuals undergoing induction or augmentation of labor will be included. Patients with any contraindication to continuous oxytocin at randomization, or for whom cesarean section is anticipated at randomization will be excluded. Patients with prolonged rupture of membranes and patients with intraamniotic infection prior to randomization will also be excluded.
Using blocked randomization via computer-generated randomization scheme, subjects will be randomized with equal probability to 60-minute oxytocin rest or usual care with continuous oxytocin. Trial participants and their health care team will be aware of their assignment. Participants in the intervention group will undergo 60-minute oxytocin rest. With the permission of the clinical team, they will be able to break from continuous fetal monitoring to rest, shower, walk, or eat during this time. After 60 minutes, oxytocin will be restarted at 2 mU/min and subsequently increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are seen. Subjects in the control group will receive continuous oxytocin infusion, increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are noted.
The remainder of labor care will be at the discretion of the clinical team. Prior to hospital discharge, demographic and clinical data from each participant and their infant will be obtained via chart review.
The primary site for the trial will be ChristianaCare Health System.
- Conditions
- Prolonged Labor, Failed Induction, Labor Dystocia
- Being tested
- Oxytocin rest
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin restOther
Also called pit rest
60-minute oxytocin rest
| Study group | Role | What they receive |
|---|---|---|
| 60-minute oxytocin rest | Experimental | Not described Receives: Other: Oxytocin rest |
| Usual care with continuous oxytocin infusion | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean rate
Number of participants delivered by cesarean
Measured: At time of delivery
Secondary outcomes (10)
Time to delivery (hours)
defined as time from enrollment to delivery time, regardless of mode of delivery
Measured: From randomization to delivery
Time to vaginal delivery (hours)
defined as time from enrollment to delivery time, for patients with vaginal delivery (cesarean delivery censored)
Measured: From randomization to delivery
Time to active labor (hours)
defined as time from enrollment to first exam with cervical dilation ≥6cm (cesarean delivery at <6cm dilation censored)
Measured: From randomization to delivery
Duration of active labor (hours)
defined as time from first exam with cervical dilation ≥6cm to delivery time (cesarean delivery censored)
Measured: From randomization to delivery
Composite maternal adverse outcome
to include operative vaginal delivery, obstetric anal sphincter injury, postpartum wound complications (wound cellulitis requiring antibiotics, wound reopened for fluid collection or infection, wound dehiscence), intraamniotic infection, postpartum endometritis, postpartum hemorrhage, deep vein thrombosis (DVT)/pulmonary embolism (PE), ICU admission, maternal death
Measured: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Composite neonatal adverse outcome
to include NICU admission ≥48 hours, APGAR score at 5 minutes <7, cord pH <7.00, intubation and mechanical ventilation ≥12 hours, neonatal sepsis, hypoxic ischemic encephalopathy, stillbirth or neonatal death
Measured: From date of delivery to date of hospital discharge for neonate (or up to 28 days of life)
Labor Agentry Scale score
The LAS is a validated tool that captures patient perception of control over the labor process. It will be administered to all enrolled patients between 6 and 96 hours after delivery. The scale asks subjects to rate their agreement with multiple statements about the labor process from 1 (almost always) to 7 (rarely), with interpretation of ratings varying by statement.
Measured: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Rate of intraamniotic infection (IAI)
defined as maternal temperature ≥ 38.0°C in the intrapartum period and initiation of antibiotics in the intrapartum period
Measured: From randomization to delivery
Rate of postpartum endometritis
defined as maternal temperature ≥ 38.0°C in the postpartum period AND initiation of antibiotics in the postpartum period
Measured: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Rate of postpartum hemorrhage
defined as quantitative blood loss ≥ 1000 mL (preferred) OR estimated blood loss ≥ 1000 mL (if QBL not performed or not available)
Measured: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start19 Mar 2024
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa C Logue, Principal investigator, Christiana Care Health ServicesMatthew K Hoffman, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268431
- Sponsor's protocol ID
- 43084
- Acronym
- ORCA
- Status last verified
- Oct 2024
- First submitted
- 13 Feb 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06268431
- Acronym / sponsor ID
- ORCA / 43084
- Conditions
- Prolonged Labor, Failed Induction, Labor Dystocia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This open-label randomized trial of consenting pregnant people with prolonged latent labor aims to determine whether 60-minute oxytocin rest reduces risk for cesarean when compared to continuous oxytocin infusion. As secondary aims, this trial will also assess the impact of 60-minute oxytocin rest on: measures of the length of labor, risk for adverse maternal and neonatal outcomes, and measures of patient autonomy and sense of control.
The investigators will enroll 350 patients with singleton pregnancies at ≥36 weeks gestation with prolonged labor in the latent phase, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin. Both nulliparous and multiparous individuals undergoing induction or augmentation of labor will be included. Patients with any contraindication to continuous oxytocin at randomization, or for whom cesarean section is anticipated at randomization will be excluded. Patients with prolonged rupture of membranes and patients with intraamniotic infection prior to randomization will also be excluded.
Using blocked randomization via computer-generated randomization scheme, subjects will be randomized with equal probability to 60-minute oxytocin rest or usual care with continuous oxytocin. Trial participants and their health care team will be aware of their assignment. Participants in the intervention group will undergo 60-minute oxytocin rest. With the permission of the clinical team, they will be able to break from continuous fetal monitoring to rest, shower, walk, or eat during this time. After 60 minutes, oxytocin will be restarted at 2 mU/min and subsequently increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are seen. Subjects in the control group will receive continuous oxytocin infusion, increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are noted.
The remainder of labor care will be at the discretion of the clinical team. Prior to hospital discharge, demographic and clinical data from each participant and their infant will be obtained via chart review.
The primary site for the trial will be ChristianaCare Health System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60-minute oxytocin rest | Experimental | Other: Oxytocin rest |
| Usual care with continuous oxytocin infusion | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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
- Known intraamniotic infection at randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin restAlso: pit rest60-minute oxytocin rest | Other | 60-minute oxytocin rest |
Primary outcome
Cesarean rate
Time frame: At time of delivery
Number of participants delivered by cesarean
10 secondary outcomes
Time to delivery (hours)
Time frame: From randomization to delivery
Time to vaginal delivery (hours)
Time frame: From randomization to delivery
Time to active labor (hours)
Time frame: From randomization to delivery
Duration of active labor (hours)
Time frame: From randomization to delivery
Composite maternal adverse outcome
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Composite neonatal adverse outcome
Time frame: From date of delivery to date of hospital discharge for neonate (or up to 28 days of life)
Labor Agentry Scale score
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Rate of intraamniotic infection (IAI)
Time frame: From randomization to delivery
Rate of postpartum endometritis
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Rate of postpartum hemorrhage
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa C Logue principal investigator
Christiana Care Health Services
Matthew K Hoffman principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin rest in people with Prolonged Labor and Failed Induction, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa C Logue ((302)-733-6563, teresa.logue@christianacare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean rate (time frame: At time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.