Condition category
Pregnancy and Childbirth
Date applied
20/09/2012
Date assigned
08/10/2012
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is still considerable variation in how women are managed with regard to feeding in the period immediately following Caesarean delivery. Some doctors will allow fluids after 6 hours and food only when there is physical evidence of bowel activity like bowel sounds or the passage of wind. In our centre, most doctors allow fluid on return to the ward and food to follow as tolerated. This means that both fluid and food are only started when the patient requests them. It has been shown that starting to drink whilst still in the recovery area (within 30 minutes of Caesarean) is safe and associated with high satisfaction. We believe that encouraging both food and drink when the patient returns to ward immediately after Cesarean, when there is still no pain as the spinal anaesthetic is still effective, will allow a meal to be eaten in comfort and this will allow bowel function to return more quickly. We think that the return of bowel function and the feel good sensation from eating a meal will speed up recovery and generate a feeling of wellbeing. The aim of this study is to evaluate the effects of ‘early feeding’ in terms of patient satisfaction and intolerability (as demonstrated by vomiting).

Who can take part?
Women admitted for a planned Caesarean delivery under spinal anaesthetic.

What does the study involve?
On return to the ward after their Caesarean delivery, the women are randomly allocated to either early or on demand feeding. Women allocated to early feeding are served food (a sandwich) and fluid as soon as possible after their return to the ward from the operating theatre and asked to consume without delay. Women allocated to on demand feeding are told that food and drink will be served for their consumption on request. In the first 24 hours after the operation we recorded patient satisfaction, any vomiting episodes, feelings of nausea, bloating and pain, time to first passage of wind and first bowel sound, use of anti-emetic (anti-vomiting) drugs, time to removal of urinary catheter/passing urine, length of hospital stay, and use of additional pain relief. We ask the patients whether they would recommend their allocated feeding regimen to a friend, and whether they would prefers to be fed as soon as possible or at their own pace in a future Caesarean.

What are the possible benefits and risks of participating?
It is possible that early feeding may cause nausea and vomiting. If this happens patients will be given medication to help with these symptoms.

When does the study take place?
August 2012 to August 2013.

Where does the study take place?
University of Malaya Medical Centre (Malaysia).

Who is funding the project?
The study is funded by an internal research grant from the University of Malaya (Malaysia).

Who is the main contact?
Dr Aizura Adlan

Trial website

Contact information

Type

Scientific

Primary contact

Dr Aizura Syafinaz Ahmad Adlan

ORCID ID

Contact details

University of Malaya
Department of Obstetrics & Gynaecology
Faculty of Medicine
Kuala Lumpur
50603
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

931.7

Study information

Scientific title

Early feeding versus on demand feeding after planned Caesarean delivery: a randomised trial

Acronym

Study hypothesis

Early (as soon as returned to the ward from the operating theatre) compared with on demand feeding after an uncomplicated planned Caesarean delivery under spinal anaesthesia will result in a faster return to normal bodily function and be well tolerated. Hence it is anticipated that patient satisfaction will increase and vomiting frequency not impacted by early feeding.

Ethics approval

University of Malaya Medical Centre Medical Ethics Committee, 19/07/2012, ref: 931.7

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Caesarean section

Intervention

Early feeding with food and fluid served to the patient for immediate consumption as soon as possible after patient returns to the ward OR On demand feeding with food and fluid served to the patient on the ward only as requested by the patient.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient satisfaction using a 10 cm Visual Analog Scale (VAS)
2. Vomiting episodes in the first 24 hours post operation

Secondary outcome measures

1. Nausea Verbal Numerical Rating Scale (VNRS) score at 8, 16 and 24 hours
2. Bloating VNRS score at 8, 16 and 24 hours
3. Pain VNRS score at 8, 16 and 24 hours
4. Passage of first flatus
5. First bowel sound
6. Anti-emetic use post delivery
7. Time to mobilization
8. Time to removal of urinary catheter/passing urine
9. Length of hospital stay
10. Additional analgesia in first 24 hours

Questionnaire at 24 hours:
1. Recommend feeding regimen to a friend: 5-point Likert scale
2. In a future Caesarean: prefer to be fed as soon as possible/at my own pace

Overall trial start date

24/08/2012

Overall trial end date

23/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Admitted for a planned caesarean delivery
2. Age ≥ 18 years
3. Spinal anaesthesia
4. Singleton viable pregnancy
5. Gestation ≥ 37 weeks

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

443 women

Participant exclusion criteria

1. Major placenta praevia
2. No concurrent severe medical problems
3. Complicated Caesarean delivery
3.1. Significant intra-abdominal adhesions
3.2. Blood loss > 800 ml
3.3. Bowel, bladder or ureteric injury
3.4. Myomectomy
3.5. Hysterectomy
3.6. Significant adnexal surgery
4. Atonic uterus during Caesarean
5. Adherent placenta
6. Ongoing concern about post Caesarean haemorrhage
7. Any intra-operative development precluding early feeding as identified by provider
8. Magnesium sulphate infusion

Recruitment start date

27/08/2012

Recruitment end date

23/08/2013

Locations

Countries of recruitment

Malaysia

Trial participating centre

University of Malaya
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya (Malaysia)

Sponsor details

Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor type

University/education

Website

http://www.umhtmc.com

Funders

Funder type

University/education

Funder name

University of Malaya (Malaysia) ref: RG450_12HTM

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes