NCT03800251

Brief Summary

The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 6, 2019

Last Update Submit

January 10, 2019

Conditions

Gastric EmptyingPregnancy

Keywords

Gastric EmptyingPregnancyElective Cesarean sectionFasting

Outcome Measures

Primary Outcomes (1)

  • Time interval required to return to the fasting grade.

    The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).

    2 hours

Secondary Outcomes (3)

  • Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section

    10 minutes

  • Time taken for the antral cross sectional area (measured by ultrasound) to reach <9.6 cm2 (suggested cut off value for ingested volumes < 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink

    2 hours

  • Antral cross sectional area at 2 hours

    2 hours

Study Arms (1)

Fasting parturients at term

OTHER

Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study

Dietary Supplement: Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml

Interventions

Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/mlDIETARY_SUPPLEMENT

Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink

Fasting parturients at term

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Elective LSCS
  • yrs
  • gestation \>38 gestation weeks

You may not qualify if:

  • Multiple pregnancy
  • Previous upper GI surgery
  • Known disorder of gastric emptying
  • Hiatus Hernia
  • BMI \>40
  • Diabetes Mellitus, Gestational Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coombe Women and Infants University Hospital

Dublin, D08XW7X, Ireland

RECRUITING

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Petar Popivanov

CONTACT

+353 (01) 4085662ppopivanov@coombe.ie

Michelle Walsh

CONTACT

+353 (01) 4085662michowalsh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 11, 2019

Study Start

June 6, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

January 11, 2019

Record last verified: 2019-01

Locations

IE(1)