Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section

Post Operative Recovery Clinical Trial

Official title:

Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03680391
• Other study ID #: 41
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Cairo University
• Contact: Ahmed maged, MD
• Phone: +2001005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Operative Recovery

Intervention

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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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