Effect of gentamicin in combination with metronidazole to prevent of post caesarean infection

Efficacy of single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post caesarean infection: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44462542

Enrollment

652

Registered

2011-09-12

Start date

2011-10-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Post-caesarean infection Infections and Infestations Other obstetric conditions, not elsewhere classified

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 o

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 en

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026