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NCT05033041 · ClinicalTrials.gov registry record · Phase 4
Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT05033041: Completed Phase 4 study, sponsored by Northwestern University.
NCT05033041 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05033041, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
Change in gastric volume (mL) determined by gastric ultrasound before and 30 minutes after administration of study drug. Gastric volumes were calculated from the cross sectional area (CSA) area using both the Perlas (Volume=27.0+14.6\*(RLD CSA (cm2)-1.28 \* age)) and the Roukhomovsky method (volume=(0.18\*RLD CSA (mm2))+(0.11\*SUP CSA (mm2)-62.4) methods.
Interventions
- DRUG Study drug metoclopramide
- DRUG Study drug placebo administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2024-02-08 |
| Phase | Phase 4 |
What the finished NCT05033041 record still lists
NCT05033041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Study drug metoclopramide is the first listed.
NCT05033041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05033041 about?
NCT05033041 is a clinical study titled "Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide". 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 anesthes...
What is the current status of trial NCT05033041?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2021-10-20. Estimated completion is 2024-02-08.
What interventions are being tested in trial NCT05033041?
The interventions under investigation include: Study drug metoclopramide (DRUG), Study drug placebo administration (DRUG).
Who is sponsoring clinical trial NCT05033041?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05033041's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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