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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06268431
Other study ID # 43084
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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