ANODE: Prophylactic antibiotics for the prevention of infection following operative delivery

Not Applicable

Completed

• Conditions: Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Child (all Subtopics); Disease: Reproductive Health & Childbirth; Pregnancy and Childbirth

• Registration Number: ISRCTN11166984
• Lead Sponsor: niversity of Oxford

Brief Summary

1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30041702 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31097213 (added 20/05/2019) 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31590702 (added 10/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-23
• Study Completion: 2019-01-31
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 3427

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed or suspected maternal infection within 6 weeks of delivery.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Need for additional perineal care/breast feeding determined within 6 weeks of delivery<br> 2. Hospital admissions and diagnoses measured at one-year post delivery<br> 3. Hospital bed stay/hospital and GP visits/wound breakdown/antibiotic side effects determined within 6 weeks of delivery<br> 4. Maternal general health determined within 6 weeks of delivery<br> 5. Relief/dyspareunia/ability to sit comfortably to feed the baby determined within 6 weeks of delivery<br> 6. Perineal wound infection determined within 6 weeks of delivery<br> 7. Cases of surgical site infection (perineal) determined within 6 weeks of delivery<br> 8. Cases of systemic sepsis determined within 6 weeks of delivery<br>