Intraabdominal irrigation at caesarean delivery and infectious morbidity: randomised controlled trial (RCT)
| ISRCTN | ISRCTN64436929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64436929 |
| Protocol serial number | N/A |
| Sponsor | Farhat Hached University Teaching Hospital (Tunisia) |
| Funder | Farhat Hached University Teaching Hospital (Tunisia) |
- Submission date
- 15/05/2005
- Registration date
- 20/09/2005
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Dr Samir Hidar
Scientific
Scientific
71, rue Ch Kallala
Sousse
4011
Tunisia
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Post operative infectious complications (including post operative fever and/or postoperative endometritis [ACOG definitions]) |
| Key secondary outcome measure(s) |
Post operative change in hematocrit and hemoglobin |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Tunisia
Study participating centre
71, rue Ch Kallala
Sousse
4011
Tunisia
4011
Tunisia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
