Condition category
Pregnancy and Childbirth
Date applied
26/08/2016
Date assigned
13/09/2016
Last edited
15/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fasting (not eating or drinking) before surgery is essential if a patient is going to receive a general anaesthetic (be put to sleep) for surgery. This is because when a person is anaesthetised, the body’s natural reflexes stop. If the stomach has food or drink in it, there is a risk that it may be brought up and inhaled into the lungs (aspiration), which can affect breathing as well as cause damage to the lungs. As a rule, patients need to fast for a minimum of six hours after having a light meal (e.g. tea and toast), for two hours after having clear fluids, and for eight hours after a full meal. Pregnant women have a higher risk of aspiration because of the various changes that happen to the body during pregnancy. The aim of this study is to find out whether six hours fasting time is enough for heavily pregnant women to have an empty stomach.

Who can participate?
Adult women who are at least 36 weeks pregnant with a single baby.

What does the study involve?
Participants receive a phone call a day or two before their first antenatal (pregnancy) visit after 36 weeks at the hospital advising them not to eat or drink anything for 6 hours after having a light meal before the appointment. At the appointment, participants have their stomach scanned with an ultrasound probe in order to see how much is in their stomach. After the scan, participants are allowed to eat and drink as normal.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involves with participating in this study.

Where is the study run from?
The National Maternity Hospital (Ireland)

When is the study starting and how long is it expected to run for?
August 2016 to December 2016

Who is funding the study?
The National Maternity Hospital (Ireland)

Who is the main contact?
Dr Sheeba Hakak
shakak@nmh.ie

Trial website

Contact information

Type

Public

Primary contact

Dr Sheeba Hakak

ORCID ID

Contact details

Department of Anaesthesia
The National Maternity Hospital
2 Hollis Street
Dublin
Dublin 2
Ireland
+353 1 6373100
shakak@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC 22-2016

Study information

Scientific title

Is six hours’ fasting time enough in term pregnancy ? A prospective observational cohort study using ultrasound to determine the residual gastric volume in fasted pregnant patients of ≥36 weeks gestation

Acronym

Study hypothesis

The aim of the study is to determine whether six hours fasting time is enough in term pregnancy by performing ultrasound of the stomach after six hours of fasting.

Ethics approval

HSE Research Ethics Committee (National Maternity Hospital, Dublin), 06/09/2016.

Study design

Prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

See additional files

Condition

Anaesthesia during pregnancy

Intervention

Participating patients are contacted lead investigator a day or two before their regular antenatal appointment and given instructions what time to start their fast, and what to eat just before starting fasting (i.e. tea and toast). They will also be informed the location of the scan.

On the day of the appointment, the lead investigator will meet the patients and confirm the fasting times and carry out a gastric ultrasound in the supine position first followed by right lateral decubitus position (RLD) at their antenatal appointment after having fasted for six hours.

Patients charts will be reviewed by the lead investigator to obtain the necessary information like weight, height, and BMI.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Percentage of patients who have a critical residual gastric volume after six hours of fasting is determined
by assessing gastric volumes in ml/kg using gastric ultrasound at the study visit.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2016

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Singleton pregnancy with a gestational age of 36 weeks or above
3. Ability to understand study protocol and provide informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

75

Participant exclusion criteria

1. Patient refusal to participate
2. Comorbidities affecting gastrointestinal motility, such as diabetes or preecclampsia
3. Previous gastric surgeries,hiatus hernia
4. BMI >35
5. Oligo or polyhydramnios on most recent scan
6. Severe intrauterine growth retardation

Recruitment start date

15/09/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

Ireland

Trial participating centre

The National Maternity Hospital
2 Holles street
Dublin
Dublin 2
Ireland

Sponsor information

Organisation

The National Maternity Hospital

Sponsor details

2 Hollis Street
Dublin
Dublin 2
Ireland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The National Maternity Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

30/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/09/2016: Participant information sheet uploaded.