Clinical trial NCT06268431: Oxytocin Rest to Reduce Cesarean Delivery
Official title: Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolonged Labor
Failed Induction
Labor Dystocia
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean rate
timeFrame: At time of delivery
Secondary outcomes:
measure: Time to delivery (hours)
timeFrame: From randomization to delivery
measure: Time to vaginal delivery (hours)
timeFrame: From randomization to delivery
measure: Time to active labor (hours)
timeFrame: From randomization to delivery
measure: Duration of active labor (hours)
timeFrame: From randomization to delivery
measure: Composite maternal adverse outcome
timeFrame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
measure: Composite neonatal adverse outcome
timeFrame: From date of delivery to date of hospital discharge for neonate (or up to 28 days of life)
measure: Labor Agentry Scale score
timeFrame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
measure: Rate of intraamniotic infection (IAI)
timeFrame: From randomization to delivery
measure: Rate of postpartum endometritis
timeFrame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
measure: Rate of postpartum hemorrhage
timeFrame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Other outcomes:
Locations:
city: Newark
country: United States
facility: ChristianaCare Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Teresa C Logue
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Services
name: Matthew K Hoffman
role: PRINCIPAL_INVESTIGATOR
References: