NCT04338737

Brief Summary

3 different post ceseraen secton feeding regmen are compared

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

April 1, 2020

Last Update Submit

April 6, 2020

Conditions

Keywords

early feeding ,late feeding

Outcome Measures

Primary Outcomes (2)

  • duration minutes till return of bowel sound

    hearing of intestinal sound

    time interval in minutes from the end of surgery till the return of intestinal sound

  • maternal satisfaction from time of initiation of oral feeding after caesarean section.

    Assessment of patient satisfaction before discharge from hospital using visual analogue scale.

    before discharge from hospital (range of 24 hours)

Study Arms (3)

fluid and soft food

ACTIVE COMPARATOR

It consists of 100 patients that will be allocated for early post-operative oral feeding receiving water and clear fluid approximately 2 hours after surgery, followed by soft food and regular diet 4 hours later irrespective to intestinal sounds, flatus or stool.

Other: timming of feeding

fluid only

ACTIVE COMPARATOR

It consists of 100 patients that will be allocated for early Postoperative oral feeding receiving water and clear fluid approximately 2 hours after surgery till the return of intestinal sounds, then soft food and regular diet later on.

Other: timming of feeding

Npo

ACTIVE COMPARATOR

It consists of 100 patients that will receive no oral feeding till passage of flatus instead 2 to 3 Litres of intravenous fluid will be used for feeding. Water and fluid will be then offered, followed by soft foods and then a regular diet.

Other: timming of feeding

Interventions

post-operative oral feeding receiving water and clear fluid after surgery, followed by soft food and regular diet

Npofluid and soft foodfluid only

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age from 20 to 40.
  • Primigravida and previous 1 or two cesarean section.
  • Elective cesarean section.
  • Regional anaesthesia.
  • Singleton pregnancy

You may not qualify if:

  • Medical disorders as (sever preeclampsia, diabetes, liver or kidney diseases).
  • Intraoperative intestinal injury.
  • Previous major abdominal surgery except cesarean section.
  • Obstructed labor with

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor of obstetrcs and gynecology

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 8, 2020

Study Start

June 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP