Clinical trial NCT03680391: Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section
Official title: Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Operative Recovery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction before discharge from hospital
timeFrame: 2 days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed maged, MD
role: PRINCIPAL_INVESTIGATOR
References: