Intraabdominal irrigation at caesarean delivery and infectious morbidity: randomised controlled trial (RCT)

ISRCTN	ISRCTN64436929
DOI	https://doi.org/10.1186/ISRCTN64436929
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Samir Hidar
Scientific

71, rue Ch Kallala
Sousse
4011
Tunisia

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Intraabdominal irrigation at caesarean delivery and infectious morbidity can modify post operative infectious morbidity.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2005
Completion date	30/11/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	250
Key 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
Key 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.
Date of first enrolment	01/01/2005
Date of final enrolment	30/11/2005

71, rue Ch Kallala

Sousse
4011
Tunisia

Farhat Hached University Teaching Hospital (Tunisia)
Hospital/treatment centre

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

"ROR"	https://ror.org/0059hys23

Hospital/treatment centre

Farhat Hached University Teaching Hospital (Tunisia)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan