Condition category
Infections and Infestations
Date applied
21/01/2008
Date assigned
05/02/2008
Last edited
05/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heleen van Beekhuizen

ORCID ID

Contact details

PO Box 228
Lindi
-
Tanzania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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).

Study design

Evaluator-blind randomised controlled non-inferiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (only in Kiswahili)

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

21/01/2008

Overall trial end date

21/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Delivery through caesarean section
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

160

Participant 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

Recruitment start date

21/01/2008

Recruitment end date

21/01/2009

Locations

Countries of recruitment

Tanzania

Trial participating centre

PO Box 228
Lindi
-
Tanzania

Sponsor information

Organisation

Sokoine Regional Hospital (Tanzania)

Sponsor details

PO Box 1011
Lindi
-
Tanzania

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Sokoine Regional Hospital (Tanzania)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes