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Effect of gentamicin in combination with metronidazole to prevent of post caesarean infection
ISRCTN ISRCTN44462542
DOI 10.1186/ISRCTN44462542
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of gentamicin in combination with metronidazole to prevent of post caesarean infection
Scientific title Efficacy of single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post caesarean infection: a randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis There is a significant difference in cumulative incidence of post caesarian infection between clients under single dose antibiotic regime and women under multiple doses antibiotic regimen

As of 22/03/2012, the following changes have been made on the trial record.
Anticipated end date has been updated from 30/03/2012 to 30/06/2012.
Target number of participants have been updated from 200 participants will be enrolled into the study, 100 in each study allocation arm to 652 participants will be enrolled into the study, 326 in each study allocation arm.
Lay summary Lay summary under review 3
Ethics approval Bugando University College of Health Sciences Research Committee, 22 August 2011 ref: BREC/001/39/2011
Study design Interventional, open label, two armed, randomised, single centre study
Countries of recruitment Tanzania
Disease/condition/study domain Post-Caesarean infection
Participants - inclusion criteria All pregnant women planned for emergency caesarean section and have consented for the study
Participants - exclusion criteria 1. Fever (temperature of 38 degrees and above)
2. Prolonged obstructed labor
3. Prolonged premature rupture of membranes (rupture of membrane more than twelve hours)
4. Features of chorioamnionitis (i.e. foul smelling lochia, uterine tenderness associated with fever)
5. Allergic to the antibiotics used in the study
6. Used antibiotics in the 24 hours preceding the operation
7. Will receive blood transfusion before, during or after caesarian section
8. Non pregnant women
Anticipated start date 01/10/2011
Anticipated end date 30/06/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 652 participants will be enrolled into the study, 326 in each study allocation arm
Interventions Study participants will be randomly allocated in two study arms, A and B.

Study Arm A:
Will receive a single intravenous single dose gentamicin (160mg) plus metronidazole 500mg 30-60 minutes before operation

Study Arm B:
Will be those who will receive multiple doses; gentamicin (160mg) plus metronidazole (500mg) 30-60 minutes after operation for 24 hours

Simple randomization will be used, 200 similar envelopes will be prepared and inside each of the 100 sealed envelopes there will be small paper marked “study arm A”. The remaining sealed envelopes will contain small papers marked “study arm B”. All sealed envelopes will be mixed thoroughly in a box before selection of an envelope is done. Each study participant will select one sealed envelope and give it to the researcher to open. Then will get antibiotic prophylaxis according to her allocated group.
Primary outcome measure(s) 1. Surgical site infection will be our primary outcome - the assessment for any evidence of surgical site infection will be done 72 hours after caesarian section as well as on follow up days (day 7 and day 30 post caesarean section)
2. Presence of fever (febrile morbidity), signs and symptoms of abdominal wound infection or endometritis will indicate surgical site infection
3. Febrile morbidity will be defined by temperature above 380 C at least 4 hours apart on two or more occasions excluding the first 24 hours after delivery
4. Abdominal wound infection will be defined by partial or total dehiscence or presence of purulent or serous discharge from the wound with indurations, warmth and tenderness
5. Endometritis will be defined by presence of fever (380 C or above) in association with one or more of the following: uterine tenderness or foul smelling lochia
6. In both groups, the bladder catheter will be removed after 24 hours. Wound care will follow the standard scheme in both groups, the occlusive dressing applied in the theatre and removed after 48 hours.
7. Patient will be discharged on day 3 if there was no sign of infection or complication and asked to return on day 7 in order to remove stitches. Then she will come on the day 30 post caesarean section for reassessment. On day 7 and day 30, axillary temperature will be measured, and abdomen and wound will be examined for signs of infection and sutures will be removed on first follow up visit.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Bugando University College of Health Sciences (Tanzania)
Trial website
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22720689
Contact name Dr  Anthony  Massinde
  Address Bugando University College of Health Sciences
Box 1464
  City/town Mwanza
  Zip/Postcode -
  Country Tanzania
  Tel +255 754 465 957
  Email amassinde@bugando.ac.tz
Sponsor Bugando University College of Health Sciences (Tanzania)
  Address Box 1464
  City/town Mwanza
  Zip/Postcode -
  Country Tanzania
  Email principal@bugando.ac.tz
  Sponsor website: http://196.46.110.189/buchs/
Date applied 05/09/2011
Last edited 08/05/2013
Date ISRCTN assigned 12/09/2011
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