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

Not Applicable

Completed

• Conditions: Maternal recovery post unplanned caesarean delivery; Pregnancy and Childbirth

• Registration Number: ISRCTN12380398
• Lead Sponsor: niversity of Malaya

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37244640/ (added 16/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-04
• Study Completion: 2023-01-16
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 501

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 18/10/2021:<br>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<br>2. Vomiting rate in the first 24 hours post-operative collected from patient's vomiting diary prior to discharge<br><br>Previous primary outcome measure:<br>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<br>2. Vomiting rate in the first 24 hours post-operative collected from patient's diary prior to discharge