Topic: Reproductive health and childbirth
Conditions
Interventions
Co-amoxiclav versus placebo, A single intravenous dose (1g amoxycillin/200mg clavulanic acid in 20ml water for injections for active drug, 20ml 0.9% saline for placebo)
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female aged 16 years or over 2. Mental capacity (ability to give informed consent) 3. Have had an operative vaginal delivery at at least 36 weeks gestation
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 04/05/2018: 1. Clinical indication for ongoing antibiotic administration post-delivery e.g. due to confirmed antenatal infection, 3rd or 4th degree tears. Note that receiving antenatal antibiotics e.g. for maternal Group B Streptococcal carriage or prolonged rupture of membranes, is not a reason for exclusion if there is no indication for ongoing antibiotic prescription post-delivery. 2. Known allergy to penicillin or to any of the components of co-amoxiclav, as documented in hospital notes. 3. History of anaphylaxis (a severe hypersensitivity reaction) to another ß-lactam agent (e.g. cephalosporin, carbapenem or monobactam), as documented in hospital notes. Previous exclusion criteria: 1. Clinical indication for ongoing antibiotic administration post-delivery (e.g. due to confirmed antenatal infection, third or fourth degree tears) 2. Known allergy to penicillin (as documented in hospital notes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed or suspected maternal infection within 6 weeks of delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Need for additional perineal care/breast feeding determined within 6 weeks of delivery 2. Hospital admissions and diagnoses measured at one-year post delivery 3. Hospital bed stay/hospital and GP visits/wound breakdown/antibiotic side effects determined within 6 weeks of delivery 4. Maternal general health determined within 6 weeks of delivery 5. Relief/dyspareunia/ability to sit comfortably to feed the baby determined within 6 weeks of delivery 6. Perineal wound infection determined within 6 weeks of delivery 7. Cases of surgical site infection (perineal) determined within 6 weeks of delivery 8. Cases of systemic sepsis determined within 6 weeks of delivery | — |
Countries
United Kingdom
Contacts
Public ContactNelly Owino
Outcome results
None listed