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NCT Number: NCT06268431

Oxytocin Rest to Reduce Cesarean Delivery

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ChristianaCare Health System

Newark, Delaware, 19718, United States

Location status: Recruiting

Location contact

Teresa C Logue

CONTACT

[email protected]

302-733-6563

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Oxytocin rest

Other

60-minute oxytocin rest

Other names: pit rest

Primary outcomes

  1. Cesarean rate

    Time frame: At time of delivery

    Number of participants delivered by cesarean

Secondary outcomes

  1. Time to delivery (hours)

    Time frame: From randomization to delivery

    defined as time from enrollment to delivery time, regardless of mode of delivery

  2. Time to vaginal delivery (hours)

    Time frame: From randomization to delivery

    defined as time from enrollment to delivery time, for patients with vaginal delivery (cesarean delivery censored)

  3. Time to active labor (hours)

    Time frame: From randomization to delivery

    defined as time from enrollment to first exam with cervical dilation ≥6cm (cesarean delivery at <6cm dilation censored)

  4. Duration of active labor (hours)

    Time frame: From randomization to delivery

    defined as time from first exam with cervical dilation ≥6cm to delivery time (cesarean delivery censored)

  5. Composite maternal adverse outcome

    Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days

    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

  6. Composite neonatal adverse outcome

    Time frame: From date of delivery to date of hospital discharge for neonate (or up to 28 days of life)

    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

  7. Labor Agentry Scale score

    Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days

    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.

  8. Rate of intraamniotic infection (IAI)

    Time frame: From randomization to delivery

    defined as maternal temperature ≥ 38.0°C in the intrapartum period and initiation of antibiotics in the intrapartum period

  9. Rate of postpartum endometritis

    Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days

    defined as maternal temperature ≥ 38.0°C in the postpartum period AND initiation of antibiotics in the postpartum period

  10. Rate of postpartum hemorrhage

    Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days

    defined as quantitative blood loss ≥ 1000 mL (preferred) OR estimated blood loss ≥ 1000 mL (if QBL not performed or not available)

Study contacts

Contact information is provided by the study sponsor or research team.

Teresa C Logue

CONTACT

[email protected]

(302)-733-6563

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Randomized Controlled Trial

Acronym: ORCA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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