Operation Wound; Infection, Endometritis
Conditions
Keywords
Cesarean, Operative site infection, Vaginal wash, Clorhexidine, Endometritis
Brief summary
To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).
Interventions
DRUGClorhexidine
Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.
DRUGSaline solution
Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.
Sponsors
Sistema Nacional de Investigación (SNI) - Panamá
Saint Thomas Hospital, Panama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women with gestation between 34 and 41 6/7 weeks. * Premature rupture of membranes (\> 6 hours). * Use of prophylactic antibiotic 1 hour previous to cesarean section.
Exclusion criteria
* Any source of infection diagnosed previous to surgery. * Fever of unknown origin previous to surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases of endometritis after cesarean section | 15 days | Endometritis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases of cesarean site infection | 15 days | Operative site infection |
| Number of cases of fever (38°C or above) in the puerperium | 15 days | Puerperal fever |
Countries
Panama
Outcome results
None listed