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
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