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

Immediate versus on-demand maternal full feeding after unplanned caesarean section in labour: a randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12380398
Enrollment
500
Registered
2021-10-04
Start date
2021-10-18
Completion date
Unknown
Last updated
2024-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal recovery post unplanned caesarean delivery Pregnancy and Childbirth

Interventions

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 emergenc

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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 patien

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026