Condition category
Surgery
Date applied
29/09/2020
Date assigned
01/10/2020
Last edited
02/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A Caesarean section is an operation to deliver a baby through a cut made in the tummy and womb.
Women going for Caesarean section require anesthesia of the lower body.
All patients planned for elective Caesarean section are traditionally not allowed to eat or drink (fast) from 12 midnight before the operation. This is because when the anesthetic is used, the body's reflexes are temporarily stopped. If the stomach has food and drink in it, there's a risk of vomiting.
Several studies have proven that allowing patients to drink water up to the surgery call time is most effective in reducing the rate of nausea and vomiting hence improving the recovery time after surgery. However, the traditional practice is to keep patients fasted for a minimum of 6 hours. This study should prove that allowing pregnant patients to consume clear fluids until surgery call time will reduce the rate of vomiting and improve satisfaction rate.

Who can participate?
Pregnant women, more than or equal to 18 years of age, who are planned for elective caesarean section, who are not in labour.

What does the study involve?
Participants will be randomly allocated to 2 groups:
1. Kept fasted from 12 midnight before the operation
2. Light food up to 6 hours, clear fluids up to surgery call time (max 500 ml of water)
Participants will be closely monitored before, during, and after their surgery.

What are the possible benefits and risks of participating?
There may or may not be of any benefits to participants. Information obtained from this study will help improve standard practice for all women going for elective caesarean sections.
For those who are kept fasted from midnight, there is a risk of hunger and thirst. They will be assessed from time to time and if required they will be administered fluids. For those patients who are allowed to take water freely till surgery call time they may be a very small risk of vomiting, those patients will be monitored and treatment will be given accordingly.

Where is the study run from?
University Malaya (Malaysia)

When is the study starting and how long is it expected to run for?
October 2019 to December 2021

Who is funding the study?
University Malaya (Malaysia)

Who is the main contact?
Dr Sabeetha Segaran, sabeetha23@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sabeetha Segaran

ORCID ID

http://orcid.org/0000-0002-1365-4025

Contact details

No 25 jalan 20 / 8
Paramount gardens
Petaling jaya
46300
Malaysia
+60 (0)163225967
sabeetha23@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

54826 -S1

Study information

Scientific title

Preoperative standard fasting as opposed to free access to oral water in elective Caesarean sections – a randomised trial

Acronym

Study hypothesis

Patient allowed to drink clear fluids up to operating theater (OT) call time have a lower vomiting rate and better satisfaction rate.

Ethics approval

Approved 28/9/2020, Medical Research Ethics Committee (Institute of Research Management & Services (IPPP), Level 7, Research Management & Innovation Complex, University of Malaya, 50603 Kuala Lumpur; +60 03-79493209; ummc@ummc.edu.my), ref: 2020623-8813

Study design

Single-centre clinical interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Nausea and vomiting associated with regional anesthesia during elective Caesarean section

Intervention

Patients who have agreed to participate in the study will be randomised into 2 groups:
1. Kept fasted from 12 midnight before the operation
2. Light food up to 6 hours, clear fluids up to OT call time (max 500 ml of water)

Patients from both the groups would be given standard aspiration prophylaxis at OT call time as per anaesthetic protocol – Mist Sodium citrate, IV Metaclopromide and IV Ranitidine


Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Vomiting intraoperative = yes or no (any vomiting from the time of entry to OT until 6 hours after the start of the surgery)
2. Patient satisfaction – VNRS score 0 to 10 - assessed at day 1 post-operation

Secondary outcome measures

1. Vomiting (yes or no):
1.1. Preoperative: Any vomiting from the time of fast from midnight to entry to OT
1.2. Intra operative: Any vomiting from the time of entry to OT to OT end time
1.3. Immediate post op: Any vomiting from the end of OT time till 24 hours post-op
1.4. Post op Day 1: Any vomiting from 24 hours post-op until time of discharge
2. Feeling thirsty measured using VNRS (0 to 10) upon arrival to OT
3. Feeling hungry measured using VNRS (0 to 10) upon arrival to OT
4. Feeling nauseous measured using VNRS (0 to 10) upon arrival to OT
5. Blood glucose measured using Refloflux upon arrival to OT
6. Ketonuria or glycosuria measured using urine dipstick upon arrival to OT
7. Nausea measured using VNRS (0 to 10) post-op in OT
8. Requirement for IV hydration (yes or no – based on clincal judgement) in ward and in reception
9. Heaving /retching (sub-vomiting) (yes or no) during the post- spinal to intraoperative interval
10. Blood pressure (mmHg) during the post-spinal to intraoperative interval
11. Medication given to maintain blood pressure during the post- spinal to intraoperative interval
Post operation time to:
12. First oral feed
13. First flatus
14. Resting pain score (day 1 before mobilisation) VNRS 0 to 10
15. Interval from surgery to ambulation
16. Maternal fever to discharge (>38°C)

Overall trial start date

01/10/2019

Overall trial end date

01/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients planned for elective caesarean section
2. Age of  >18 years
3. Gestational age of >37 weeks
4. Receiving spinal anesthesia
5. Singleton pregnancy
6. Reassuring fetal status (normal fetal heart tracing)
  

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500

Participant exclusion criteria

1. BMI >40 kg/m²
2. Placenta Praevia Major
3. Placenta accreta
4. Twins and multiple births
5. Emergency Caesarean sections
6. Patients in labour or having contractions
7. DM in pregnancy requiring insulin therapy
8. Anticipated significant risk of extended surgery (e.g intra-abdominal adhesions, myomectomy)
9. Anticipated significant conversion risk to general anaesthesia
10. Anticipated high risk of perioperative vomiting
11. Anticipated ICU admission

Recruitment start date

01/10/2020

Recruitment end date

01/10/2021

Locations

Countries of recruitment

Malaysia

Trial participating centre

University of Malaya
Department of Obstetrics and Gynecology Lembah Pantai
Kuala Lumpur
59100
Malaysia

Sponsor information

Organisation

University of Malaya

Sponsor details

Department of Obstetrics and Gynecology
University Malaya
Lembah Pantai
Kuala Lumpur
59100
Malaysia
+60 03-7949 4422
ummc@ummc.edu.my

Sponsor type

University/education

Website

https://www.um.edu.my/

Funders

Funder type

University/education

Funder name

Universiti Malaya

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Malaysia

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/10/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2020: Internal review. 30/09/2020: Trial’s existence confirmed by University of Malaya.