Health Condition 1: O860- Infection of obstetric surgical wound Health Condition 2: O861- Other infection of genital tract following delivery Health Condition 3: O85- Puerperal sepsis Health Condition 4: O864- Pyrexia of unknown origin following delivery Health Condition 5: O862- Urinary tract infection followingdelivery
Conditions
Interventions
Intervention1: amoxicillin-clavulanic acid (1gm/200mg): Single dose of intravenous (IV) amoxicillin-clavulanic acid (1gm/200mg) within 6 hours of delivery.
Control Intervention1: Normal saline: Single
Sponsors
Christian Medical College and Hospital Vellore
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women aged 16 years or above, willing and able to give informed consent. 2.Women who have had an operative vaginal delivery at 36+0 completed weeks or greater gestation.
Exclusion criteria
Exclusion criteria: 1.Clinical indication for continuation of antibiotic administration post-delivery 2.Known allergy to penicillin or to any of the components of co-amoxiclav, as previously identified 3.History of anaphylaxis to another �²-lactam agent (e.g. cephalosporin, carbapenem or monobactam)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed or suspected maternal infection Timepoint: Any time within 6 weeks of delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Need for additional pain relief 2. Days of hospitalization 3. Ability to sit comfortably and feed the baby (VAS) 4. Number of hospital visits in the first 6 weeks 5. Number of readmissions 6. Quality of life score Timepoint: Within 6 weeks post partum | — |
Countries
India
Contacts
Public ContactAnne George Cherian
Christian Medical College and Hospital, Vellore
Outcome results
None listed