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Status unknownNCT03070795Updated Mar 10, 2017

Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital

An interventional study of early feeding and delayed feeding in Cesarean Section Complications, sponsored by University of Ghana Medical School. Status unknown at 1 site in Ghana. Open to female participants aged Up to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by University of Ghana Medical School · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
Up to 49 Years
Sex
Female
01

Study summary

study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule.

Read the detailed description

patients who are scheduled to undergo elective cesarean section are randomised to two groups, one group will be allowed to feed 4 hours after cesarean section while the other group will be fed traditionally by feeding on the first post op day. gastrointestinal signs and symptoms will be measured such as post operative ileus, vomiting, nausea, abdminal distension. other parameters to be measured include time to ambulate out of bed after surgery, time to start breastfeeding after surgery. satisfaction with both feeding regimes will be assessed after surgery and the incedence of wound infecion will be compared between the two groups after two weeks durung the post natal review.

02

Conditions studied

  • Cesarean Section Complications

Keywords

  • post-operative ileus
  • early feeding
  • delayed feeding
03

Who can participate

Ages eligible
Up to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

Uncomplicated elective Cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions.

Women who give consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Elective Cesarean sections complicated by severe haemorrhage, bowel injury requiring bowel manipulation, repair, resection and anastomosis or colostomy.

Women who require a Cesarean hysterectomy. Women who require a Post-partum hysterectomy. Mothers with severe pre-eclampsia. Mothers with sickle cell disease. Mothers with pregestational or gestational diabetes. Mothers who have been scheduled for Cesarean section and require general anaesthesia.

Women who have had a previous laparotomy other than a Cesarean section.

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    early feeding

    patients undergoing elective cesarean section will be allowed to feed (sips) four hours after cesarean section.

    Procedure: early feeding

  • Active comparator
    delayed feeding

    patients undergoing elective cesarean section will be allowed to feed on post operation day 1 (12 hours post op).

    Procedure: delayed feeding

Interventions

  • Procedureearly feeding

    start oral sips four hours after cesarean section

  • Proceduredelayed feeding

    start oral feeding on post operation day 1 (\>12hours) after surgery

05

What researchers measure

Primary outcomes

  1. post-operative ileus

    onset of vomiting \>4 times per day

    Time frame: within 3 days after surgery

Secondary outcomes

  1. Crampy abdominal pain

    abdominal pain after feeding following cesarean section

    Time frame: within 3 days after surgery

  2. Time of initiation of breastfeeding post operatively

    time it takes to start breastfeeding after cesrean section

    Time frame: within 3 days after surgery

  3. Woman's satisfaction

    measure level of satisfaction with feeding regime using an assessment scoring tool. this is in the form of a questionair adminstered to the client by the investigator.

    Time frame: within 3 days after surgery

  4. Time of ambulation out of bed after surgery

    time it takes for the mother to get out of bed and sit up or mobilize

    Time frame: within 3 days after surgery

  5. Incedence of a wound infection

    measure of the presence of wound infection in both arms on day of discharge and 2 weeks post discharge

    Time frame: within 2 weeks of surgery

06

Study locations

1 of 1 sites recruiting
  • Korle-Bu Teaching Hospital
    Accra, Greater Accra, Ghana
    • mustapha salifu · Contact · +233 243407809
    • mustapha salifu · Contact · rdo@kbth.gov.gh · +233 302 666 766
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03070795
Lead sponsor
University of Ghana Medical School
Responsible party
Sponsor
First posted
Mar 6, 2017
Start date
Feb 23, 2017
Primary completion
Jun 20, 2017 (estimated)
Completion
Aug 20, 2017 (estimated)
Last update
Mar 10, 2017

Study contacts

Kojo A. Apea-Kubi, MBChB, MGCPS
Contact
kojoapeakubi@gmail.com
0264625142 ext. +233
mustapha salifu
Contact
0243407809
kojo apea-kubi
principal investigator · Korle Bu Teaching Hospital
isaac abiaw
principal investigator · Korle Bu Teaching Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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