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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN06127083
Enrollment
160
Registered
2008-02-05
Start date
2008-01-21
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative infection after caesareans Infections and Infestations Post-operative infection

Interventions

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 s

Sponsors

Sokoine Regional Hospital (Tanzania)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Delivery through caesarean section 2. Informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026