An interventional study of Oxytocin rest in Prolonged Labor, Failed Induction and Labor Dystocia, sponsored by Christiana Care Health Services. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Christiana Care Health Services · Not applicable, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 350 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Oxytocin rest
60-minute oxytocin rest
Also known as: pit rest
Cesarean rate
Number of participants delivered by cesarean
Time frame: At time of delivery
Time to delivery (hours)
defined as time from enrollment to delivery time, regardless of mode of delivery
Time frame: From randomization to delivery
Time to vaginal delivery (hours)
defined as time from enrollment to delivery time, for patients with vaginal delivery (cesarean delivery censored)
Time frame: From randomization to delivery
Time to active labor (hours)
defined as time from enrollment to first exam with cervical dilation ≥6cm (cesarean delivery at \<6cm dilation censored)
Time frame: From randomization to delivery
Duration of active labor (hours)
defined as time from first exam with cervical dilation ≥6cm to delivery time (cesarean delivery censored)
Time frame: From randomization to delivery
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
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
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
Time frame: From date of delivery to date of hospital discharge for neonate (or up to 28 days of life)
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. 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.
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
Rate of intraamniotic infection (IAI)
defined as maternal temperature ≥ 38.0°C in the intrapartum period and initiation of antibiotics in the intrapartum period
Time frame: From randomization to delivery
Rate of postpartum endometritis
defined as maternal temperature ≥ 38.0°C in the postpartum period AND initiation of antibiotics in the postpartum period
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
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)
Time frame: From date of delivery to date of hospital discharge for mother, expected average of 3 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Feb 2026, 22 months after the start.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's planned 22 months is close to that.
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