Plain English Summary
Background and study aims
Operative vaginal delivery, also known as assisted delivery, accounts for more than 10% of births in the UK. In an operative vaginal delivery, forceps or a vacuum device are used in order to help to deliver a baby during the final stages of labour. It has been found that women who have had this type of delivery have a higher risk of infection following the birth of their baby (postpartum infection). An operative vaginal delivery can cause accidental tearing of the vagina or even require a surgical incision (episiotomy) to be made; these are both possible sources of infection. Although there are concerns about over-prescribing antibiotics, it may be a good way to stop postpartum infections from developing. The aim of this study is to find out whether giving new mothers a single dose of an antibiotic after an assisted delivery could help to prevent postpartum infection.
Who can participate?
Healthy women aged 16 and over who have had an operative vaginal delivery.
What does the study involve?
Participants are randomly allocated into two groups. Those in the first group are given an injection directly into a vein (intravenous) of an antibiotic solution (amoxicillin) immediately after giving birth. Participants in the second group are given a placebo solution (salt solution with no antibiotic). When the women are discharged from hospital, signs of infection are recorded. After six weeks, participants are asked to complete a questionnaire about any problems they have experienced with pain, healing or infection.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
NPEU Clinical Trials Unit, Oxford (UK)
When is the study starting and how long is it expected to run for?
September 2009 to August 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
ANODE: A randomised controlled trial of prophylactic Antibiotics to investigate the prevention of infection following Operative vaginal Delivery
The aim of this study is to find out if giving mothers a single dose of an antibiotic after they have had an assisted delivery helps to prevent infection.
Randomised; Interventional; Design type: Not specified, Prevention
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Child (all Subtopics); Disease: Reproductive Health & Childbirth
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)
Primary outcome measure
Confirmed or suspected maternal infection within 6 weeks of delivery.
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
Planned Sample Size: 3424; UK Sample Size: 3424
Participant 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 β-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)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
NPEU Clinical Trials Unit
National Perinatal Epidemiology Unit (NPEU) University of Oxford Old Road Campus
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30041702