Post Operative Feeding After Cesarean Section

A Randomized Controlled Study of Early Versus Delayed Oral Post Operative Feeding After Cesarean Section

3 different post ceseraen secton feeding regmen are compared

Study Overview

• Status: Unknown
• Conditions: Feeding Patterns
• Intervention / Treatment: Other: timming of feeding

Detailed Description

300 women admitted to the labor and delivery unit in kasr Elainy teaching hospital, Following the decision to perform a cesarean section because of obstetric indications. The study involved only elective cesarean sections.

The 300 patients participated in this work and will be randomly and equally divided into three groups:

1. Group A :

   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.

2. Group B :

   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.

3. Group C :

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: fluid and soft food; 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; post-operative oral feeding receiving water and clear fluid after surgery, followed by soft food and regular diet
ACTIVE_COMPARATOR: fluid only; 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; post-operative oral feeding receiving water and clear fluid after surgery, followed by soft food and regular diet
ACTIVE_COMPARATOR: Npo; 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; post-operative oral feeding receiving water and clear fluid after surgery, followed by soft food and regular diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (ACTUAL): April 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: early feeding ,late feeding
• Other Study ID Numbers: MS-235-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No