Post Operative Feeding After Cesarean Section
A Randomized Controlled Study of Early Versus Delayed Oral Post Operative Feeding After Cesarean Section
1 other identifier
interventional
300
0 countries
N/A
Brief Summary
3 different post ceseraen secton feeding regmen are compared
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
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
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedApril 8, 2020
April 1, 2020
9 months
April 1, 2020
April 6, 2020
Conditions
Keywords
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 COMPARATORIt 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.
fluid only
ACTIVE COMPARATORIt 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.
Npo
ACTIVE COMPARATORIt 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.
Interventions
post-operative oral feeding receiving water and clear fluid after surgery, followed by soft food and regular diet
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
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