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

February 8, 2024 updated by: Jennifer Banayan, Northwestern University

Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital and Prentice Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 Study Drug Metoclopramide
Intravenous administration of 10 mg metoclopramide
Drug: Study drug metoclopramide
Intravenous administration of 4 mg metoclopramide
Placebo Comparator: Group 2 Study Drug Placebo
Intravenous administration of sterile normal saline
Drug: Study drug placebo administration
Intravenous administration of placebo (sterile normal saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gastric volume (mL)
Time Frame: 30 minutes after administration of study drug
Change in gastric volume (mL) determined by ultrasound before and 30 minutes after administration of study drug
30 minutes after administration of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence (number of events) of nausea and vomiting
Time Frame: 24 hours
Number of episodes (events) of intraoperative nausea and vomiting during cesarean delivery and post-operative nausea and vomiting after cesarean delivery (correlated to metoclopramide administration and gastric volume)
24 hours
Adverse events
Time Frame: 48 hours
Number of adverse events (akathisia, dystonia, abdominal cramping, extrapyramidal symptoms) experienced between the two study groups.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Jennifer Banayan, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00215570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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