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Clinical Trials/NCT03413748
NCT03413748UnknownNot Applicable

Comparative Study Between Intraabdominal Irrigation and Non Irrigation During Elective Cesarean Section

Cairo University1 site in 1 country200 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
Intestinal recovery

Study Overview

Brief Summary

All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation

Detailed Description

All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation during the procedure of elective lower segment cesarean section

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Singleton pregnancy
  • •Gestational age 36 - 40 weeks
  • •Elective Cesarean section
  • •Under spinal anaesthesia

Exclusion Criteria

  • •Chronic diseases as Diabetes and hypertension
  • •Intestinal diseases as Crohn's disease
  • •Psychological and neurological conditions affecting pain sensation
  • •women with ferbrile morbidity before the operation
  • •The need for general anesthesia

Arms & Interventions

Peritoneal irrigation

Active Comparator

Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum

Intervention: Elective Cesarean Section (Procedure)

Peritoneal irrigation

Active Comparator

Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum

Intervention: Peritoneal irrigation (Other)

Non peritoneal irrigation

Active Comparator

No Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum

Intervention: Elective Cesarean Section (Procedure)

Outcomes

Primary Outcomes

Intestinal recovery

Time Frame: 24 hours after operation

Auscultation of intestinal sounds

Secondary Outcomes

  • postoperative pain(24 hours after surgery)
  • Temperature(every hour for 16 hours after the operation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Maged

professor

Cairo University

Study Sites (1)

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