Peritoneal Irrigation at Elective Cesarean Section

NCT ID: NCT03413748

Last Updated: 2018-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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

Conditions

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Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Peritoneal irrigation

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

Group Type ACTIVE_COMPARATOR

Elective Cesarean Section

Intervention Type PROCEDURE

lower segment cesarean section

Peritoneal irrigation

Intervention Type OTHER

Irrigation of peritoneal cavity with 500 - 1000 ml of warm normal saline

Non peritoneal irrigation

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

Group Type ACTIVE_COMPARATOR

Elective Cesarean Section

Intervention Type PROCEDURE

lower segment cesarean section

Interventions

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Elective Cesarean Section

lower segment cesarean section

Intervention Type PROCEDURE

Peritoneal irrigation

Irrigation of peritoneal cavity with 500 - 1000 ml of warm normal saline

Intervention Type OTHER

Other Intervention Names

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CS

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

+2001005227404

Amira Yehia, MD

Role: CONTACT

Other Identifiers

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23

Identifier Type: -

Identifier Source: org_study_id

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