Phase 4
N=72
Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
Pregnancy · Cesarean Section · Aspiration
Bottom Line
View on ClinicalTrials.gov: NCT05033041 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Gastric Volume (mL) — -1; -2; 0; 1 Milliliters — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Study drug metoclopramide (Drug); Study drug placebo administration (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gastric Volume (mL) |
-1; -2; 0; 1 | .001 sig |
| SECONDARY Subject Report of Nausea During Cesarean Section |
14; 18 | — |
| SECONDARY Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Intraoperative Nausea Occurrences |
1; 2 | — |
| SECONDARY Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes |
26; 20 | — |
| SECONDARY Subject Experienced Vomiting During Cesarean Section |
3; 5 | — |
| SECONDARY Number of Intraoperative Vomiting Occurrences |
1; 1 | — |
| SECONDARY Time From Intrathecal Anesthesia to Vomiting Episode in Minutes. |
34; 26 | — |
| SECONDARY Antiemetic Prophylaxis |
35; 32; 34; 32 | — |
| SECONDARY PACU Antiemetic Treatment (n) |
5; 1 | — |
| SECONDARY Nausea After PACU Discharge |
3; 6 | — |
| SECONDARY Elapsed Time From Study Drug to Second Ultrasound |
30; 30 | — |
| SECONDARY Second Ultrasound Cross Sectional Area (cm^2) |
3.7; 3.5; 4.0; 4 | — |
| SECONDARY Post Treatment Estimated Volume (mL) Second Ultrasound |
43; 39; 55; 54 | — |
| SECONDARY Second Ultrasound Volume >1.5 * Weight (kg) |
0; 0; 2; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy (ASA Physical Status 2)
- Age >18 years old
- Non-obese (BMI 18 years
- Term (>37 week)
- Non-laboring parturient
- Single gestation
- Scheduled for a cesarean delivery and NPO
Exclusion Criteria
- Systemic disease such as diabetes mellitus (type 1 or 2)
- Multiple gestation
- Abnormality of upper GI tract
- History of GI tract related surgical procedures
- Use of gastric motility medications
- Active labor
- Renal impairment (creatinine >2)
- Non-English speaking
- Cognitively impaired
- History of QT prolongation
- Use of general anesthesia
Data sourced from ClinicalTrials.gov (NCT05033041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.