Effect of Early Posroperative Feeding on Gastrointestinal... | NCT03680391

Studies
Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section

NCT03680391

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 21, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Post Operative Recovery

Interventions

Cesarean section

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2018Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Sep 19, 2018

First Submission Date that Met QC Criteria

Sep 19, 2018

First Posted Date

Sep 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2018

Last Update Posted Date

Sep 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

all Women included in the study have undergo history taking and general examination
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cesarean section	Procedure	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

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.

all Women included in the study have undergo history taking and general examination
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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Ahmed maged, MD	Contact	+2001005227404		prof.ahmedmaged@gmail.com
Mohamed Shalaby, MD	Contact			mohamed_shalaby85@hotmail.com

Name	Affiliation	Role
Ahmed maged, MD	Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school		Cairo		12111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative