Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide

NCT05033041 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STU00215570
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pregnancy; Gastric Volume; Ultrasound Measurement; Aspiration Prevention; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Subject Report of Nausea During Cesarean Section

  24 hours

• Adverse Events

  72 hours

• Intraoperative Nausea Occurrences

  24 hours

• Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes

  24 hours

• Subject Experienced Vomiting During Cesarean Section

  24 Hours

Other Outcomes (2)

• First Ultrasound Stomach Cross-sectional Area (cm2)

  After consent obtained

• First Ultrasound Volume Greater Than 1.5 * Weight (kg)

  After consent obtained

Study Arms (2)

Group 1 Study Drug Metoclopramide

ACTIVE COMPARATOR

Intravenous administration of 10 mg metoclopramide

Drug: Study drug metoclopramide

Group 2 Study Drug Placebo

PLACEBO COMPARATOR

Intravenous administration of sterile normal saline

Drug: Study drug placebo administration

Interventions

Study drug metoclopramide DRUG

Intravenous administration of 10 mg metoclopramide

Group 1 Study Drug Metoclopramide

Study drug placebo administration DRUG

Intravenous administration of placebo (sterile normal saline)

Group 2 Study Drug Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant undergoing cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy (ASA Physical Status 2)
• Age \>18 years old
• Non-obese (BMI \<40 kg/m2)
• Age \>18 years
• Term (\>37 week)
• Non-laboring parturient
• Single gestation
• Scheduled for a cesarean delivery and NPO

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital and Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• 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.

  PMID: 28045707 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.

  PMID: 20993766 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.

  PMID: 26580836 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.

  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.

  PMID: 26422744 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.

  PMID: 22307240 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.

  PMID: 20091567 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.

  PMID: 23302981 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.

  PMID: 24893784 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.

  PMID: 26097988 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.

  PMID: 29265187 BACKGROUND

Limitations and Caveats

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.

Results Point of Contact

• Title: Paul C. Fitzgerald,RN,BSN,MS
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Jennifer Banayan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research pharmacy to prepare the study medication blinding the participant, care providers, investigator and outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled blinded study

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: October 20, 2021
• Primary Completion: January 30, 2024
• Study Completion: February 8, 2024
• Last Updated: September 11, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)