Immediate versus on-demand oral feeding after emergency caesarean delivery in labour

ISRCTN	ISRCTN12380398
DOI	https://doi.org/10.1186/ISRCTN12380398
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2021827-10517
Sponsor	University of Malaya
Funder	Universiti Malaya

Submission date: 01/10/2021
Registration date: 04/10/2021
Last edited: 16/02/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Early food and drink intake after a Caesarean section has positive benefits on early recovery with no complications. The aim of this study is to find out whether immediate feeding or on-demand feeding improves patient satisfaction and to see the overall characteristics of patients' recovery after surgery. This is an important area for future improvement in the management of Caesarean delivery.

Who can participate?
Pregnant women aged 18 – 45 years in labour with no serious medical illnesses who undergo an emergency Caesarean section without complications and no known risk for immediate repeated surgery

What does the study involve?
The participants will be given a sandwich meal and 250 ml drink of their choice upon returning from the operation theatre after delivery, either immediately or on-demand. The postoperative course and maternal satisfaction are assessed before hospital discharge.

What are the possible benefits and risks of participating?
There may or may not be any benefits to participants. Information obtained from this study will help improve standard practice for women undergoing emergency Caesarean section. Early oral intake after surgery is expected to be safe as the guidelines encourage it and based on a recent study the risk of vomiting is low. Patients will be assessed from time to time and allowed for repeated meals and drinks. Patients may have a higher risk of vomiting; those patients will be monitored and medication to prevent and stop vomiting will be given accordingly.

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

When is the study starting and how long it is expected to run for?
July 2021 to January 2023

Who is funding the study?
University of Malaya Medical Center (Malaysia)

Who is the main contact?
Dr Nurulhuda binti Ahmad Sani
huda.sani@ummc.edu.my

Contact information

Dr Nurulhuda binti Ahmad Sani
Scientific

University of Malaya Medical Centre, UMMC
Jalan Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia

ORCID ID	0000-0002-5340-2201
Phone	+60 (0)3 79492049
Email	huda.sani@ummc.edu.my

Dr Jesrine Hong
Scientific

University of Malaya Medical Centre, UMMC
Jalan Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia

ORCID ID	0000-0001-8585-2357
Phone	+60 (0)3 79492049
Email	jesrine@um.edu.my

Dr Asmahani Asmary
Scientific

University of Malaya Medical Centre
UMMC
Jalan Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia

Phone	+60 (0)3 79492049
Email	asmahani.as@ummc.edu.my

Study information

Primary study design	Interventional
Study design	Single-centre open-label randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Immediate versus on-demand maternal full feeding after unplanned caesarean section in labour: a randomised trial
Study acronym	ImFLUCS
Study objectives	Immediate feeding for women after an unplanned caesarean section will increase overall maternal satisfaction but will not increase vomiting.
Ethics approval(s)	Approved 22/09/2021, University of Malaya Medical Centre, Kuala Lumpur – Medical Research Ethics Committee (UMMC-MREC, Lembah Pantai, 59100, Kuala Lumpur, Malaysia; +60 (0)379493209; ummc-mrec@ummc.edu.my), ref: MREC ID No: 2021827-10517
Health condition(s) or problem(s) studied	Maternal recovery post unplanned caesarean delivery
Intervention	The study will be conducted in the labour suite and postnatal ward at UMMC. The potential participants will receive standard care during labour. Women who consented to participate and undergo emergency caesarean section will be given a sandwich meal and 250 ml drink of their choice upon returning from operation theatre after delivery, either immediately or on-demand. Participants will be randomised into two arms (1:1) via labelled opaque envelopes. Randomisation will be generated by a random sequence generator, provided by random.org. to avoid bias, in blocks of 4 and 8. At this point sealed envelope (intention to treat) which reveals their allocated oral feeding plan, either immediate full feeding or on-demand feeding. The lowest number of the sealed envelope will be taken. A: Sandwich meal and 250 ml drink of their choice given as soon as possible upon returning to labour suite or postnatal ward while the regional anaesthesia still in action. They should consume as much as they can. B: Sandwich meal and 250 ml drink of their choice served on demand. They should consume as much as they can. Post-operative outcomes and maternal satisfaction will be collected prior to discharge.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measure as of 18/10/2021: 1. Overall maternal satisfaction with the given oral feeding regimen measured using a numerical rating score (VNRS) 0-10 (higher score = higher satisfaction) prior to hospital discharge 2. Vomiting rate in the first 24 hours post-operative collected from patient's vomiting diary prior to discharge Previous primary outcome measure: 1. Overall maternal satisfaction with the given oral feeding regimen measured using a 10 cm visual numerical rating score (VNRS) Score 0-10 (higher score higher satisfaction) prior to hospital discharge 2. Vomiting rate in the first 24 hours post-operative collected from patient's diary prior to discharge
Key secondary outcome measure(s)	Current secondary outcome measures as of 18/10/2021: 1. Time to first feed, measured by taking the time the participant starts taking orally 2. Food quantum consumed at first feed, quantified by a 6-point scale collected after the first feed 3. Fluid quantum consumed at first feed, quantified by a 6-point scale collected after the first feed 4. Pain, nausea and bloating measured using a horizontal visual numerical rating scale (VNRS, scored 0-10) to score the initial intensity of symptoms (low score, less intense symptom), at 30 minutes after first feed, 8, 16, 24 hours and after 24 hours postoperative up to hospital discharge 5. Opiate analgesia usage collected from hospital records (yes or no and frequency of usage) before discharge 6. Parenteral anti-emetic usage collected from hospital records (yes or no and frequency of usage) before discharge 8. First breastfeeding time collected at 4 - 48 hours post op review by asking the participant her time of first latching and satisfactory breastfeeding. The response taken from the participant on satisfactory breastfeeding is their own term of satisfaction 9. First bowel sound collected at 4 - 48 hours post-op review by auscultation of bowel sounds every 4 hours. The first bowel sound noticed will be recorded 10. First passage of flatus collected at 4 - 48 hours post op review by asking the participant the timing and date 11. Second mealtime collected at 4 - 48 hours post op review by asking the participant the timing and date 12. Cessation of IV fluid time collected from hospital record before discharge 13. Removal of urinary catheter (CBD) collected from hospital records before discharge (the timing and date) 14. First urination after CBD removal collected by asking the participant the timing and date at 4 - 48 hours post op review 15. Ambulation time collected from hospital records and by asking the participants the timing and date before discharge 16. Vomiting during the postoperative stay collected from the patient's diary before discharge (yes or no, frequency of vomiting) 17. Maternal complications collected from hospital records upon discharge Previous secondary outcome measures: 1. Time to first feed, measured by taking the time the participant starts taking orally 2. Food quantum consumed at first feed, quantified by a 6-point scale collected after the first feed 3. Fluid quantum consumed at first feed, quantified by a 6-point scale collected after the first feed 4. Pain, nausea, vomiting and bloating measured using a diary to record symptoms with yes or no answer and a horizontal visual numerical rating scale (VNRS, scored 0-10) to score the initial intensity of symptoms (low score, less intense symptom), at 30 minutes after first feed, 8, 16, 24 hours and after 24 hours postoperative up to hospital discharge 5. Opiate analgesia usage collected from hospital records (yes or no and frequency of usage) before discharge 6. Parenteral anti-emetic usage collected from hospital records (yes or no and frequency of usage) before discharge 7. First analgesia in ward collected from hospital records by date and time before discharge 8. First breastfeeding time collected at 4 - 48 hours post op review by asking the participant her time of first latching and satisfactory breastfeeding. The response taken from the participant on satisfactory breastfeeding is of their own term of satisfaction 9. First bowel sound collected at 4 - 48 hours post-op review by auscultation of bowel sound every 4 hours for its presence. First bowel sound noticed will be recorded 10. First passage of flatus collected at 4 - 48 hours post op review by asking the participant the timing and date 11. Second mealtime collected at 4 - 48 hours post op review by asking the participant the timing and date 12. Cessation of IV fluid time collected before discharge from hospital record and asking ward provider 13. Removal of urinary catheter (CBD) collected before discharge from hospital record and by asking participants and ward provider the timing and date 14. First urination after CBD removal collected at 4 - 48 hours post op review by asking the participant the timing and date 15. Ambulation time collected before discharge from hospital record and by asking the participants and ward provider the timing and date 16. Vomiting during the post-operative stay collected from patient's diary before discharge (yes or no, frequency of vomiting) 17. Maternal complications collected from hospital records upon discharge
Completion date	16/01/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Female
Target sample size at registration	500
Total final enrolment	501
Key inclusion criteria	1. Women in labour (cervical dilatation ≥3 cm, contraction ≥2 in 10 minutes) 2. Age 18 – 45 years 3. Singleton pregnancy 4. Gestation ≥37 weeks 5. Unplanned caesarean section 6. Regional anaesthesia 7. No instruction from the surgeon for postoperative Nil By Mouth (NBM)
Key exclusion criteria	1. Placenta praevia 2. Multiple pregnancy 3. Diabetes requiring insulin therapy 4. Maternal medical problem that requires fluid restriction 5. Patient who is suspected COVID-19 infection or COVID-19 positive 6. Estimated blood loss >1.5 l 7. Additional surgery needed (e.g., myomectomy, cystectomy, bladder or bowel repair) 8. HDU or ICU admission 9. Significant risk of re-laparotomy 10. Appeared distressed and potentially unable to provide informed consent. i.e. in severe pain
Date of first enrolment	18/10/2021
Date of final enrolment	14/01/2023

Locations

Countries of recruitment

Malaysia

Study participating centre

University of Malaya Medical Centre (UMMC)

Jalan Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nurulhuda binti Ahmad Sani (huda.sani@ummc.edu.my, nurul9613@uitm.edu.my).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		25/05/2023	16/02/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol (other)		27/08/2021	04/10/2021	No	No

Editorial Notes

16/02/2024: Publication reference and total final enrolment added.
05/12/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 30/04/2023 to 14/01/2023.
2. The overall study end date was changed from 30/06/2023 to 16/01/2023.
08/11/2022: The recruitment end date was changed from 01/11/2022 to 30/04/2023.
20/06/2022: The contact details were updated and the overall trial end date was changed from 31/12/2022 to 30/06/2023.
18/11/2021: The following changes were made to the trial record:
1. The target number of participants was changed from 528 to 500.
2. The primary and secondary outcome measures were updated.
11/10/2021: The recruitment start date was changed from 11/10/2021 to 18/10/2021.
04/10/2021: Trial's existence confirmed by University of Malaya Medical Centre, Kuala Lumpur – Medical Research Ethics Committee (UMMC-MREC).