Effect of gentamicin in combination with metronidazole to prevent of post caesarean infection
| ISRCTN | ISRCTN44462542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44462542 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/09/2011
- Registration date
- 12/09/2011
- Last edited
- 10/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
Bugando University College of Health Sciences
Box 1464
Mwanza
-
Tanzania
| Phone | +255 (0)754 465 957 |
|---|---|
| amassinde@bugando.ac.tz |
Study information
| Study design | Interventional open-label two-armed randomised single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| 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(s) | Bugando University College of Health Sciences Research Committee, 22/08/2011, ref: BREC/001/39/2011 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gentamicin, metronidazole |
| Primary outcome measure | 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 study start date | 01/10/2011 |
| Overall study end date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 652 participants will be enrolled into the study, 326 in each study allocation arm |
| Participant inclusion criteria | All pregnant women planned for emergency caesarean section and have consented for the study |
| 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
Study participating centre
-
Tanzania
Sponsor information
University/education
Box 1464
Mwanza
-
Tanzania
| principal@bugando.ac.tz | |
| Website | http://196.46.110.189/buchs/ |
"ROR" |
https://ror.org/015qmyq14 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/06/2012 | Yes | No |
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'.
