Prolonged Labor Clinical Trial
— ORCAOfficial title:
Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Multicenter Randomized Controlled Trial
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | ChristianaCare Health System | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
Christiana Care Health Services |
United States,
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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