Prevention of post-caesarean infections in low resource countries: is a single dose as adequate as a multiple dose antibiotic regiment? A randomised controlled trial
| ISRCTN | ISRCTN06127083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06127083 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/01/2008
- Registration date
- 05/02/2008
- Last edited
- 05/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 Heleen van Beekhuizen
Scientific
Scientific
PO Box 228
Lindi
-
Tanzania
Study information
| Study design | Evaluator-blind randomised controlled non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (only in Kiswahili) |
| Scientific title | Is the administration of a single prophylactic dose of ampicillin and metronidazole before caesarean section as effective as a multiple day regimen of these antibiotics to prevent postpartum maternal infection in a low resource setting? A randomised controlled trial |
| Study objectives | Single dose antibiotic prophylaxes is as effective as a multiple dose scheme in women undergoing a caesarean section in low resource setting in preventing postoperative infections. |
| Ethics approval(s) | Ethics approval received from the National Instritute for Medical Research, Dar es Salaam (Tanzania) on the 12th November 2007 (ref: NIMR/HQ/R.8a/Vol.IX/633). |
| Health condition(s) or problem(s) studied | Post-operative infection after caesareans |
| Intervention | Group 1: ampicillin 1000 mg and metronidazole 500 mg intravenous 20 minutes prior to caesarean section Group 2: ampicillin 1000 mg and metronidazole 500 mg intravenous 20 minutes prior to caesarean section followed by ampicillin 500 mg 8-hourly for two more doses and metronidazole 500 mg 8-hourly for two more doses. After completion of the intravenous (iv) doses the patients will receive oral medication for four days (total 12 doses) of amoxicillin 500 mg and metronidazole 400 mg. The follow up will be until the patients are discharged: for uncomplicated lower segment caesarean section (LSCS) this will be on day five (in case of pfannenstiel incision) and day seven (in case of median incision). When complications arise, the patient will be followed up longer, until discharge. |
| Intervention type | Other |
| Primary outcome measure | The presence of fever, endometritis, urinary tract infection, wound infection or other serious infections (such as pelvic abscess, peritonitis, sepsis). Timepoint of evaluation is on discharge (see interventions section): an independent doctor will review the wound and score the wound healing and record if any complication arose or additional antibiotics were given. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 21/01/2008 |
| Completion date | 21/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 160 |
| Key inclusion criteria | 1. Delivery through caesarean section 2. Informed consent |
| Key exclusion criteria | 1. Use of antibiotics in the last week 2. Known allergy for any of the antibiotics used 3. Greater than 24 hour rupture of membranes 4. Evident infection or fever pre- or during operation |
| Date of first enrolment | 21/01/2008 |
| Date of final enrolment | 21/01/2009 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
PO Box 228
Lindi
-
Tanzania
-
Tanzania
Sponsor information
Sokoine Regional Hospital (Tanzania)
Hospital/treatment centre
Hospital/treatment centre
PO Box 1011
Lindi
-
Tanzania
Funders
Funder type
Hospital/treatment centre
Sokoine Regional Hospital (Tanzania)
No information available
Results and Publications
| 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 |
