Investigating the use of oxytocin during the second stage of labor
Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
This study is testing if continuing oxytocin during the pushing stage of labor helps first-time moms have better delivery outcomes or if it could cause unnecessary risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04303702 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial examines the effects of continuing oxytocin administration during the second stage of labor in nulliparous women. While oxytocin is commonly used to enhance uterine contractions during the first stage of labor, its benefits and risks during the second stage remain unclear. The study aims to determine whether continuing oxytocin can improve delivery outcomes or if it poses unnecessary risks. Participants will be randomly assigned to either continue or discontinue oxytocin after reaching complete cervical dilation.
Who should consider this trial
Good fit: Ideal candidates are nulliparous pregnant women at or beyond 37 weeks of gestation who are in labor.
Not a fit: Patients with multiple gestations, major fetal anomalies, or those who are not on oxytocin at the time of complete cervical dilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence to guide the safe use of oxytocin in labor, potentially improving maternal and neonatal outcomes.
How similar studies have performed: Previous studies have shown mixed results regarding the benefits of oxytocin in labor, making this investigation both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparous pregnant women \>/= 37 weeks gestation * Singleton pregnancies * Admission for induction of labor or spontaneous labor Exclusion Criteria: * Multiple gestations * Multiparous patients * Patients with major fetal anomalies * Not on oxytocin at the time of complete cervical dilation * Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation * Maternal medical condition that prohibits prolonged second stage
Where this trial is running
St Louis, Missouri
- Barnes Jewish Hospital — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Nandini Raghuraman, MD MSCI
- Email: nraghuraman@wustl.edu
- Phone: 9186917389
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.