Using oxytocin rest to reduce cesarean deliveries in prolonged labor
Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Randomized Controlled Trial
NA · Christiana Care Health Services · NCT06268431
This study is testing if a 60-minute break with oxytocin can help reduce cesarean deliveries for women in prolonged labor.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Christiana Care Health Services (other) |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT06268431 on ClinicalTrials.gov |
What this trial studies
This open-label randomized trial aims to evaluate the effectiveness of a 60-minute oxytocin rest in patients experiencing prolonged latent labor. Participants will be randomly assigned to either the oxytocin rest group or the usual care group receiving continuous oxytocin infusion. The study will assess the impact of this intervention on the risk of cesarean delivery, the length of labor, and maternal and neonatal outcomes. The trial will enroll 350 patients with singleton pregnancies at or beyond 36 weeks gestation who meet specific criteria related to labor progression.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 and older with singleton pregnancies at 36 weeks gestation or more, experiencing prolonged latent labor.
Not a fit: Patients who are anticipated to require a cesarean section at the time of randomization or have contraindications to continuous oxytocin will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of cesarean deliveries in patients with prolonged labor.
How similar studies have performed: While oxytocin rest is a common practice, there is currently no randomized or prospective data to support its effectiveness, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newark, Delaware
- ChristianaCare Health System — Newark, Delaware, United States (RECRUITING)
Study contacts
- Principal investigator: Teresa C Logue — Christiana Care Health Services
- Study coordinator: Teresa C Logue
- Email: teresa.logue@christianacare.org
- Phone: (302)-733-6563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prolonged Labor, Failed Induction, Labor Dystocia