Oxytocin Rest to Reduce Cesarean Delivery

Prolonged Labor Clinical Trial

— ORCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268431
• Other study ID #: 43084
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: March 15, 2026

Study information

• Verified date: February 2024
• Source: Christiana Care Health Services
• Contact: Teresa C Logue
• Phone: (302)-733-6563
• Email: teresa.logue[@]christianacare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

This open-label, multicenter 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. We 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. We will include both nulliparous and multiparous individuals undergoing induction or augmentation of labor. We will exclude patients with any contraindication to continuous oxytocin at randomization, or for whom cesarean section is anticipated at randomization. We will also exclude patients with prolonged rupture of membranes and patients with intraamniotic infection prior to randomization. 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. We are planning for the trial to take place at three institutions. Our primary site will be ChristianaCare Health System.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 15, 2026
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dystocia
• Failed Induction
• Labor Dystocia
• Prolonged Labor

Intervention

Other:
• Oxytocin rest
60-minute oxytocin rest

Locations

Country	Name	City	State
United States	ChristianaCare Health System	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean rate	Number of participants delivered by cesarean	At time of delivery
Secondary	Time to delivery (hours)	defined as time from enrollment to delivery time, regardless of mode of delivery	From randomization to delivery
Secondary	Time to vaginal delivery (hours)	defined as time from enrollment to delivery time, for patients with vaginal delivery (cesarean delivery censored)	From randomization to delivery
Secondary	Time to active labor (hours)	defined as time from enrollment to first exam with cervical dilation =6cm (cesarean delivery at <6cm dilation censored)	From randomization to delivery
Secondary	Duration of active labor (hours)	defined as time from first exam with cervical dilation =6cm to delivery time (cesarean delivery censored)	From randomization to delivery
Secondary	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	From date of delivery to date of hospital discharge for mother, expected average of 3 days
Secondary	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	From date of delivery to date of hospital discharge for neonate (or up to 28 days of life)
Secondary	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.	From date of delivery to date of hospital discharge for mother, expected average of 3 days
Secondary	Rate of intraamniotic infection (IAI)	defined as maternal temperature = 38.0°C in the intrapartum period and initiation of antibiotics in the intrapartum period	From randomization to delivery
Secondary	Rate of postpartum endometritis	defined as maternal temperature = 38.0°C in the postpartum period AND initiation of antibiotics in the postpartum period	From date of delivery to date of hospital discharge for mother, expected average of 3 days
Secondary	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)	From date of delivery to date of hospital discharge for mother, expected average of 3 days