NCT03680391

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 19, 2018

Last Update Submit

September 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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 feedingearly postoperative feeding

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed maged, MD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Shalaby, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 21, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

September 21, 2018

Record last verified: 2018-09

Locations