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
Protocol serial number	N/A
Sponsor	Sokoine Regional Hospital (Tanzania)
Funder	Sokoine Regional Hospital (Tanzania)

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

PO Box 228
Lindi
-
Tanzania

Study information

Primary study design	Interventional
Study design	Evaluator-blind randomised controlled non-inferiority trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	21/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes