Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
NCT05033041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-09-11
Summary
Our objective is to compare gastric volumes (mL) between women who receive metoclopramide versus placebo prior to scheduled cesarean delivery in appropriately fasted patients. If metoclopramide is found not to reduce gastric volumes this would inform future practice guidelines for obstetric anesthesia, which currently recommends metoclopramide administration prior to cesarean deliveries.
We hypothesize that metoclopramide given to women with appropriate fasting prior to cesarean delivery does not result in any clinically significant reduction in gastric volume (mL) and therefore does not provide any additional benefit for aspiration prophylaxis but may expose patients to unnecessary side effects. A secondary objective will be to evaluate if gastric volume is a significant predictor of intraoperative nausea and vomiting.
Conditions
- Pregnancy
- Cesarean Section
- Aspiration
Interventions
- DRUG
-
Study drug metoclopramide
Intravenous administration of 10 mg metoclopramide
- DRUG
-
Study drug placebo administration
Intravenous administration of placebo (sterile normal saline)
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Jennifer Banayan, MD · Northwestern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-20
- Primary Completion
- 2024-01-30
- Completion
- 2024-02-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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