Condition category
Infections and Infestations
Date applied
05/09/2011
Date assigned
12/09/2011
Last edited
10/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A caesarean section is an operation in which an incision (cut) is made through the abdomen and uterus of a pregnant woman to deliver a baby. It is a common operation worldwide. The risk of infection after this operation is five times higher compared to vaginal birth (normal birth). Anti-bacterial drugs are usually given to the woman about to undergo caesarean section 30-60 minutes before the operation to reduce the risk of infection after the operation. Provision of a single dose of these drugs is recommended by many centers because repeated or multiple doses not have any added advantage. Infection after caesarean section is among the top five causes of admission at Bugando medical centre post delivery wards. We do not have a regulated course of antibacterial drugs which has resulted from our own studies. As a result, most of the time, pregnant women who are planned for caesarean section receive repeated doses of antibacterial drugs. The aim of this study is to assess the effectiveness of a single dose of gentamicin in combination with metronidazole compared to multiple doses of the same drugs in the prevention of infection after caesarean section.

Who can participate?
All pregnant women who present in the delivery room with labor pain and later planned for caesarean section.

What does the study involve?
Participants are randomly allocated into two groups. Participants in one group receive a single dose of gentamicin in combination with metronidazole 30-60 minutes before their operation and participants in the second group receive the same drugs before the operation and continue with metronidazole eight hourly for 24 hours.

What are the possible benefits and risks of participating?
There are no risks in participating in this study because we are not using a new treatment. The treatments we are planning to use are the ones commonly used at this department.

Where is the study run from?
Bugando medical centre, Mwanza (Tanzania)

When is the study starting and how long is it expected to run for?
October 2011 to June 2012

Who is funding the study?
Weill Bugando University College of Health Sciences (Tanzania)

Who is the main contact?
Dr Fadhili Lyimo
fadhili1810@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Massinde

ORCID ID

Contact details

Bugando University College of Health Sciences
Box 1464
Mwanza
-
Tanzania
+255 (0)754 465 957
amassinde@bugando.ac.tz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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.

Ethics approval

Bugando University College of Health Sciences Research Committee, 22/08/2011, ref: BREC/001/39/2011

Study design

Interventional open-label two-armed randomised single-centre study

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

Condition

Post-caesarean infection

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Gentamicin, metronidazole

Primary outcome measures

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 measures

No secondary outcome measures

Overall trial start date

01/10/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All pregnant women planned for emergency caesarean section and have consented for the study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

652 participants will be enrolled into the study, 326 in each study allocation arm

Participant 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

Recruitment start date

01/10/2011

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Tanzania

Trial participating centre

Bugando University College of Health Sciences
Mwanza
-
Tanzania

Sponsor information

Organisation

Bugando University College of Health Sciences (Tanzania)

Sponsor details

Box 1464
Mwanza
-
Tanzania
-
principal@bugando.ac.tz

Sponsor type

University/education

Website

http://196.46.110.189/buchs/

Funders

Funder type

University/education

Funder name

Bugando University College of Health Sciences (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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22720689

Publication citations

  1. Protocol

    Lyimo FM, Massinde AN, Kidenya BR, Konje E, Mshana SE, Efficacy of single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post-caesarean infection: study protocol for a randomized controlled trial., Trials, 2012, 13, 89, doi: 10.1186/1745-6215-13-89.

Additional files

Editorial Notes

10/02/2016: Plain English summary added On 22/03/2012 the following changes were made to the trial record: 1. The overall trial end date was changed from 30/03/2012 to 30/06/2012. 2. The target number of participants was changed 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'.