Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
NCT ID: NCT05033041
Last Updated: 2025-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2021-10-20
2024-02-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1 Study Drug Metoclopramide
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide
Intravenous administration of 10 mg metoclopramide
Group 2 Study Drug Placebo
Intravenous administration of sterile normal saline
Study drug placebo administration
Intravenous administration of placebo (sterile normal saline)
Interventions
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Study drug metoclopramide
Intravenous administration of 10 mg metoclopramide
Study drug placebo administration
Intravenous administration of placebo (sterile normal saline)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Jennifer Banayan
Principal Investigator
Principal Investigators
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Jennifer Banayan, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern Memorial Hospital and Prentice Women's Hospital
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STU00215570
Identifier Type: -
Identifier Source: org_study_id
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