Determining the best oxytocin dose for cesarean delivery
Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
This study is testing the lowest amount of oxytocin needed to help women having a cesarean delivery have better uterine contractions and reduce bleeding after childbirth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05290129 on ClinicalTrials.gov |
What this trial studies
This study aims to find the minimal effective dose of oxytocin infusion needed for laboring women undergoing cesarean delivery to ensure optimal uterine contraction and minimize postpartum hemorrhage. It employs a prospective, double-blinded design where the infusion dose is adjusted based on the previous patient's response. The goal is to establish the dose that achieves adequate uterine tone in 90% of patients. The study will be conducted at Mount Sinai Hospital in Toronto, Ontario.
Who should consider this trial
Good fit: Ideal candidates include laboring women who are undergoing cesarean delivery under neuraxial anesthesia and have had prior exposure to oxytocin.
Not a fit: Patients who have contraindications for neuraxial anesthesia or a history of severe cardiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of postpartum hemorrhage in women undergoing cesarean delivery.
How similar studies have performed: Other studies have explored oxytocin dosing in similar contexts, but this specific up-down sequential allocation approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • All patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia (at least 3 hours of prior exposure to oxytocin during labour) Exclusion Criteria: * All patients who refuse to give written informed consent * All patients who declare allergy or hypersensitivity to oxytocin * A history of hypertension and/or severe cardiac disease(s) * All patients who have contraindications for neuraxial anesthesia * All patients who will be converted to general anesthesia intraoperatively * All patients with placenta previa and multiple gestation
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mrinalini Balki, MD — Mount Sinai Hospital
- Study coordinator: Mrinalini Balki, MD
- Email: mrinalini.balki@uhn.ca
- Phone: 416-586-4800
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.