Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section

Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital

Study Overview

• Status: Unknown
• Conditions: Post Operative Recovery
• Intervention / Treatment: Procedure: Cesarean section

Detailed Description

7. Study Methods

Population of study & disease condition :

Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital.

Inclusion criteria:

• Maternal age from 20 to 40
• Primigravida and previous one or two cesarean section
• Elective cesarean section
• regional anesthesia .singleton pregnancy.

Exclusion criteria:

• age below 20 years old or above 40 years old
• medical disorders as (hypertension, diabetes , liver or kidney diseases)
• complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
• general anesthesia
• multiple pregnancy

Methodology in details:

1. all Women included in the study have undergo history taking and general examination
2. All patient in the study are randomized in two groups:

Group A:

103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage

Group B:

97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool 3_Both groups cesarean section will be held with the same technique:

• spinal anethesia
• pfennenstiel imcision
• lower segment cesarean section
• suturing uterus in two layers while exterionezed
• gentle manibulation
• no towels in gutters will be used 4_ comparison will be held between both groups according:
• postoperative intestinal sounds.
• postoperative nausea and vomiting
• postoprative abdominal distension
• postoperative pain
• postoperative ambulation
• postoperative ileus
• postoperative discharge time from hospital

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Mohamed Shalaby, MD; Email: mohamed_shalaby85@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12111
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital.

1. all Women included in the study have undergo history taking and general examination
2. All patient in the study are randomized in two groups:

Group A:

103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage

Group B:

97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool 3_Both groups cesarean section will be held with the same technique:

• spinal anethesia
• pfennenstiel imcision
• lower segment cesarean section
• suturing uterus in two layers while exterionezed
• gentle manibulation
• no towels in gutters will be used

Description

Inclusion Criteria:

• Maternal age from 20 to 40

  • Primigravida and previous one or two cesarean section
  • Elective cesarean section
  • regional anesthesia .singleton pregnancy.

Exclusion Criteria:

age below 20 years old or above 40 years old

• medical disorders as (hypertension, diabetes , liver or kidney diseases)
• complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
• general anesthesia
• multiple pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early postoperative feeding; 103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage	Procedure: Cesarean section; Both groups cesarean section will be held with the same technique: spinal anethesia; pfennenstiel imcision; lower segment cesarean section; suturing uterus in two layers while exterionezed; gentle manibulation; no towels in gutters will be used
Late postoperative feeding; 97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool	Procedure: Cesarean section; Both groups cesarean section will be held with the same technique: spinal anethesia; pfennenstiel imcision; lower segment cesarean section; suturing uterus in two layers while exterionezed; gentle manibulation; no towels in gutters will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction before discharge from hospital	satisfaction score from 1 to 10 where 1 is totally non satisfied and 10 fully satisfied	2 days after the operation

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No