NCT03413748

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

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 not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

January 22, 2018

Last Update Submit

January 26, 2018

Conditions

Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

  • Intestinal recovery

    Auscultation of intestinal sounds

    24 hours after operation

Secondary Outcomes (2)

  • Temperature

    every hour for 16 hours after the operation

  • postoperative pain

    24 hours after surgery

Study Arms (2)

Peritoneal irrigation

ACTIVE COMPARATOR

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

Procedure: Elective Cesarean SectionOther: Peritoneal irrigation

Non peritoneal irrigation

ACTIVE COMPARATOR

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

Procedure: Elective Cesarean Section

Interventions

Elective Cesarean SectionPROCEDURE

lower segment cesarean section

Also known as: CS
Non peritoneal irrigationPeritoneal irrigation
Peritoneal irrigationOTHER

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

Peritoneal irrigation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

Peritoneal Lavage

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Ahmed Maged, MD

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404prof.ahmedmaged@gmail.com

Amira Yehia, MD

CONTACT

amira_el_sayed_yehia@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

January 1, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

January 29, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)