Condition category
Pregnancy and Childbirth
Date applied
15/05/2005
Date assigned
20/09/2005
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Samir Hidar

ORCID ID

Contact details

71
rue Ch Kallala
Sousse
4011
Tunisia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Intraabdominal irrigation at caesarean delivery and infectious morbidity can modify post operative infectious morbidity.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Obstetrics and gynaecology

Intervention

The patients will be randomised into two groups:

1. Intraabdominal irrigation at caesarean delivery after fetal extraction
2. No intraabdominal irrigation at caesarean delivery after fetal extraction

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Post operative infectious complications (including post operative fever and/or postoperative endometritis [ACOG definitions])

Secondary outcome measures

Post operative change in hematocrit and hemoglobin

Overall trial start date

01/01/2005

Overall trial end date

30/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients requiring elective or emergency, primary or repeat Caesarean section and planned to have low segment transverse uterine incision with:
1. Gestational age >34 weeks
2. No fever
3. No prelabor rupture of membranes

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

250

Participant exclusion criteria

Pregnancy of less than 34 weeks of gestation, intrauterine fetal death, suspected infection, suspected uterine rupture preterm prelabor rupture of membranes of more than 48 hours.

Recruitment start date

01/01/2005

Recruitment end date

30/11/2005

Locations

Countries of recruitment

Tunisia

Trial participating centre

71, rue Ch Kallala
Sousse
4011
Tunisia

Sponsor information

Organisation

Farhat Hached University Teaching Hospital (Tunisia)

Sponsor details

Department of Obstetrics and Gynaecology
Farhat Hached University Teaching Hospital
Boulevard M. Karoui
Sousse
4000
Tunisia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Farhat Hached University Teaching Hospital (Tunisia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes