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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Active Comparator | Intravenous administration of 10 mg metoclopramide |
|
| Group 2 Study Drug Placebo | Placebo Comparator | Intravenous administration of sterile normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study drug metoclopramide | Drug | Intravenous administration of 10 mg metoclopramide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastric Volume (mL) | 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. | 30 minutes after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Report of Nausea During Cesarean Section | Subject reported intraoperative nausea during the cesarean delivery | 24 hours |
| Adverse Events | Number of reported adverse events experienced for each group. |
| Measure | Description | Time Frame |
|---|---|---|
| First Ultrasound Stomach Cross-sectional Area (cm2) | The first ultrasound of the stomach cross-sectional area in centimeters squared. | After consent obtained |
| First Ultrasound Volume Greater Than 1.5 * Weight (kg) |
Inclusion Criteria:
Exclusion Criteria:
Pregnant undergoing cesarean section.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Banayan, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital and Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28045707 | Background | Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available. | |
| 20993766 |
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72 Subjects were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Study Drug Metoclopramide | Intravenous administration of 10 mg metoclopramide Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide |
| FG001 | Group 2 Study Drug Placebo | Intravenous administration of sterile normal saline Study drug placebo administration: Intravenous administration of placebo (sterile normal saline) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Study Drug Metoclopramide | Intravenous administration of 10 mg metoclopramide Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide |
| BG001 | Group 2 Study Drug Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Gastric Volume (mL) | 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. | One subject in the placebo group did not have a paired ultrasound (missing pre-treatment). | Posted | Median | 95% Confidence Interval | Milliliters | 30 minutes after administration of study drug |
|
72 Hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 Study Drug Metoclopramide | Intravenous administration of 10 mg metoclopramide Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
We recognize the potential limitations that some providers may still choose to administer metoclopramide to augment esophageal contractions despite its limited impact on esophageal junction compliance. While metoclopramide may help augment contractions, its use in fasted patients who are at low risk of gastric contents >1.5mL/kg is unlikely to significantly impact aspiration risk, making its benefit in this context less clear.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul C. Fitzgerald,RN,BSN,MS | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2022 | Feb 21, 2025 | Prot_SAP_000.pdf |
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Randomized controlled blinded study
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Research pharmacy to prepare the study medication blinding the participant, care providers, investigator and outcomes assessor.
| Study drug placebo administration | Drug | Intravenous administration of placebo (sterile normal saline) |
|
| 72 hours |
| Intraoperative Nausea Occurrences | Number of nausea occurrences during cesarean section procedure | 24 hours |
| Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes | Total elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant. | 24 hours |
| Subject Experienced Vomiting During Cesarean Section | Subject experienced vomiting episode during the cesarean delivery procedure. | 24 Hours |
| Number of Intraoperative Vomiting Occurrences | Number of intraoperative vomiting occurrences during the cesarean section. | 24 Hours |
| Time From Intrathecal Anesthesia to Vomiting Episode in Minutes. | The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during. | 24 Hours |
| Antiemetic Prophylaxis | Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section. | 24 Hours |
| PACU Antiemetic Treatment (n) | Number of participants who required antiemetic medications in the post anesthesia care unit | 24 hours |
| Nausea After PACU Discharge | Number of participants who experienced nausea after being discharged from the post anesthesia care unit | 72 hours |
| Elapsed Time From Study Drug to Second Ultrasound | Total elapsed time in minutes after study drug administered to second gastric ultrasound. | 24 hours |
| Second Ultrasound Cross Sectional Area (cm^2) | The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered | 24 hours |
| Post Treatment Estimated Volume (mL) Second Ultrasound | Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration | 24 hours |
| Second Ultrasound Volume >1.5 * Weight (kg) | Number of subjects experiencing a volume greater than than 1.5 times weight in kilograms after the second gastric ultrasound 30 minutes after study medication administration. | 24 hours |
The first ultrasound calculated volume greater than 1.5 times weight in kilograms.
| After consent obtained |
| Background |
| MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available. |
| 26580836 | Background | Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available. |
| Background | 4. Knight M, Bunch K, Tuffnell D, Shakespeare J, Kotnis R, Kenyon S, Kurinczuk JJ (Eds.) on behalf of MBRRACE-UK. Saving Lives, Improving Mothers' Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2016-18. Oxford: National Perinatal Epidemiology Unit, University of Oxford 2020. |
| 26422744 | Background | Leus M, van de Ven A. IMAGES IN CLINICAL MEDICINE. An Acute Dystonic Reaction after Treatment with Metoclopramide. N Engl J Med. 2015 Oct;373(14):e16. doi: 10.1056/NEJMicm1412207. No abstract available. |
| 22307240 | Background | Mishriky BM, Habib AS. Metoclopramide for nausea and vomiting prophylaxis during and after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2012 Mar;108(3):374-83. doi: 10.1093/bja/aer509. Epub 2012 Feb 3. |
| 20091567 | Background | Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004943. doi: 10.1002/14651858.CD004943.pub3. |
| 23302981 | Background | Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9. |
| 24893784 | Background | Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3. |
| 26097988 | Background | Arzola C, Perlas A, Siddiqui NT, Carvalho JCA. Bedside Gastric Ultrasonography in Term Pregnant Women Before Elective Cesarean Delivery: A Prospective Cohort Study. Anesth Analg. 2015 Sep;121(3):752-758. doi: 10.1213/ANE.0000000000000818. |
| 29265187 | Background | Arzola C, Perlas A, Siddiqui NT, Downey K, Ye XY, Carvalho JCA. Gastric ultrasound in the third trimester of pregnancy: a randomised controlled trial to develop a predictive model of volume assessment. Anaesthesia. 2018 Mar;73(3):295-303. doi: 10.1111/anae.14131. Epub 2017 Dec 19. |
| 40882347 | Derived | Lu SF, McCarthy RJ, Toledo P, Thomas CL, Gaston IN, Samworth AG, Ripchik PE, Troughton MB, Lopez CE, Kruse JH, Banayan JM. Effect of metoclopramide on gastric volume and nausea and vomiting in fasted patients undergoing elective cesarean delivery: a randomized clinical equivalence trial. Int J Obstet Anesth. 2025 Nov;64:104754. doi: 10.1016/j.ijoa.2025.104754. Epub 2025 Aug 14. |
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Median | Inter-Quartile Range | Kilograms |
|
| Body Mass In kg/m^2 | Median | Inter-Quartile Range | kg/m^2 |
|
| Gestational age (weeks) | Median | Inter-Quartile Range | Weeks |
|
| Gravid (number of pregnancies) | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Prior cesarean deliveries | Number of participants who have had a previous cesarean delivery. | Count of Participants | Participants |
|
| Gastroesophageal reflux disease (GERD) | Count of Participants | Participants |
|
| Hours since last solid ingestion (NPO) | Median | Inter-Quartile Range | Hours |
|
| Time from last liquid ingestion (hours) | Median | Inter-Quartile Range | Hours |
|
| Pretreatment estimated gastric volume (mL) | Median | Inter-Quartile Range | Milliliters |
|
| Group 2 Study Drug Placebo |
Intravenous administration of sterile normal saline Study drug placebo administration: Intravenous administration of placebo (sterile normal saline) |
|
|
|
| Secondary | Subject Report of Nausea During Cesarean Section | Subject reported intraoperative nausea during the cesarean delivery | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Adverse Events | Number of reported adverse events experienced for each group. | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | Intraoperative Nausea Occurrences | Number of nausea occurrences during cesarean section procedure | Posted | Median | Inter-Quartile Range | Nausea occurrences | 24 hours |
|
|
|
| Secondary | Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes | Total elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant. | Posted | Median | Inter-Quartile Range | Minutes | 24 hours |
|
|
|
| Secondary | Subject Experienced Vomiting During Cesarean Section | Subject experienced vomiting episode during the cesarean delivery procedure. | Posted | Count of Participants | Participants | 24 Hours |
|
|
|
| Secondary | Number of Intraoperative Vomiting Occurrences | Number of intraoperative vomiting occurrences during the cesarean section. | Posted | Median | Inter-Quartile Range | Number of episodes | 24 Hours |
|
|
|
| Secondary | Time From Intrathecal Anesthesia to Vomiting Episode in Minutes. | The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during. | Posted | Median | Inter-Quartile Range | Minutes | 24 Hours |
|
|
|
| Secondary | Antiemetic Prophylaxis | Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section. | Posted | Number | participants | 24 Hours |
|
|
|
| Secondary | PACU Antiemetic Treatment (n) | Number of participants who required antiemetic medications in the post anesthesia care unit | Posted | Number | Participants | 24 hours |
|
|
|
| Secondary | Nausea After PACU Discharge | Number of participants who experienced nausea after being discharged from the post anesthesia care unit | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | Elapsed Time From Study Drug to Second Ultrasound | Total elapsed time in minutes after study drug administered to second gastric ultrasound. | Posted | Mean | Standard Deviation | Minutes | 24 hours |
|
|
|
| Secondary | Second Ultrasound Cross Sectional Area (cm^2) | The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered | Posted | Median | Inter-Quartile Range | Centimeters | 24 hours |
|
|
|
| Secondary | Post Treatment Estimated Volume (mL) Second Ultrasound | Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration | Posted | Median | Inter-Quartile Range | Milliliters | 24 hours |
|
|
|
| Secondary | Second Ultrasound Volume >1.5 * Weight (kg) | Number of subjects experiencing a volume greater than than 1.5 times weight in kilograms after the second gastric ultrasound 30 minutes after study medication administration. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Other Pre-specified | First Ultrasound Stomach Cross-sectional Area (cm2) | The first ultrasound of the stomach cross-sectional area in centimeters squared. | Posted | Median | Inter-Quartile Range | centimeters squared | After consent obtained | Ultrasounds | Ultrasounds |
|
|
|
| Other Pre-specified | First Ultrasound Volume Greater Than 1.5 * Weight (kg) | The first ultrasound calculated volume greater than 1.5 times weight in kilograms. | Posted | Number | participants | After consent obtained |
|
|
|
| Post-Hoc | Neonatal Outcome APGAR Score | Neonatal APGAR scores at 1 and 5 minutes (0-poor 10 good) | Posted | Median | Inter-Quartile Range | scores on a scale (0 poor-10 good) | 5 minutes after delivery |
|
|
|
| Post-Hoc | Neonatal Outcomes Arterial Blood Gasses | Neonatal arterial blood gas results obtained at delivery (pH). | Posted | Median | Inter-Quartile Range | pH | 5 minutes after delivery |
|
|
|
| Post-Hoc | Neonatal Outcomes Venous Blood Gas | Neonatal venous blood gas post delivery (pH) | Posted | Median | Inter-Quartile Range | pH | 5 minutes after delivery |
|
|
|
| Post-Hoc | Neonatal Outcomes: Neonatal Resuscitation | Neonate required neonatal resuscitation required after cesarean section delivery | Posted | Number | Participants | 24 hours |
|
|
|
| Post-Hoc | Neonatal Outcomes: NICU Admission | Neonate admission to the newborn intensive care unit | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Post-Hoc | Neonatal Outcomes Arterial Blood Gasses | Neonatal arterial blood gas results obtained at delivery (O2 (mmHg), CO2 (mmHg). | Posted | Median | Inter-Quartile Range | millimeters of mercury | After delivery |
|
|
|
| Post-Hoc | Neonatal Outcomes Venous Blood Gas | Neonatal venous blood gas post delivery including pH, O2 (mmHg), C02 (mmHg) | Posted | Median | Inter-Quartile Range | millimeters of mercury | After delivery |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 3 |
| 38 |
| EG001 | Group 2 Study Drug Placebo | Intravenous administration of sterile normal saline Study drug placebo administration: Intravenous administration of placebo (sterile normal saline) | 0 | 34 | 0 | 34 | 6 | 34 |
| Hypertension | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment | Hypertension during hospitalization for delivery of baby |
|
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| High fever |
|
| Muscle stiffness |
|
| Depression |
|
| Fluid retention |
|
| Hypoprolactinemia |
|
| Hypersensitivity reaction |
|
| Blood cell changes |
|
| Hypernatremia |
|
| Maternal resuscitation |
|
| Maternal hypertension |
|
| Infant gastrointestinal disturbances |
|
| Infant extrapyramidial effects |
|
| Infant methemoglobinemia |
|