Is six hours fasting time enough in term pregnancy? An ultrasound study of the stomach of fasted pregnant patients who are ≥36 weeks pregnant to determine if the 6 hours fasting time before an operation is enough in pregnancy
| ISRCTN | ISRCTN14847686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14847686 |
| Secondary identifying numbers | EC 22-2016 |
- Submission date
- 26/08/2016
- Registration date
- 13/09/2016
- Last edited
- 15/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Public
Department of Anaesthesia
The National Maternity Hospital
2 Hollis Street
Dublin
Dublin 2
Ireland
| Phone | +353 1 6373100 |
|---|---|
| shakak@nmh.ie |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN14847686_PIS_12Sep2016_V2.doc |
| 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 |
| Study objectives | 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(s) | HSE Research Ethics Committee (National Maternity Hospital, Dublin), 06/09/2016. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2016 |
| Completion date | 30/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 75 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/09/2016 |
| Date of final enrolment | 30/11/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
Dublin 2
Ireland
Sponsor information
Hospital/treatment centre
2 Hollis Street
Dublin
Dublin 2
Ireland
"ROR" |
https://ror.org/03jcxa214 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2 | 12/09/2016 | 15/09/2016 | No | Yes |
Additional files
- ISRCTN14847686_PIS_12Sep2016_V2.doc
- Uploaded 15/09/2016
Editorial Notes
15/09/2016: Participant information sheet uploaded.
