ANODE: Prophylactic antibiotics for the prevention of infection following operative delivery
| ISRCTN | ISRCTN11166984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11166984 |
| EudraCT/CTIS number | 2015-000872-89 |
| Secondary identifying numbers | 19501 |
- Submission date
- 23/09/2015
- Registration date
- 23/09/2015
- Last edited
- 10/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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?
Nelly Owino
anode@npeu.ox.ac.uk
Contact information
Public
NPEU Clinical Trials Unit
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Headington
OX3 7LF
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | ANODE: A randomised controlled trial of prophylactic Antibiotics to investigate the prevention of infection following Operative vaginal Delivery |
| Study acronym | ANODE |
| Study hypothesis | 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. |
| Ethics approval(s) | 15/SC/0442 |
| Condition | Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Child (all Subtopics); Disease: Reproductive Health & Childbirth |
| Intervention | 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) |
| Intervention type | Other |
| 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 study start date | 01/09/2015 |
| Overall study end date | 31/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 3424; UK Sample Size: 3424 |
| Total final enrolment | 3427 |
| 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 |
| 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 | 29/02/2016 |
| Recruitment end date | 13/06/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Oxford
Old Road Campus
Headington
OX3 7LF
United Kingdom
Sponsor information
Hospital/treatment centre
Nuffield Department of Obstetrics & Gynaecology
Level 3
Women's Centre
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/07/2018 | Yes | No | |
| Results article | results | 15/06/2019 | 20/05/2019 | Yes | No |
| Results article | results | 01/10/2019 | 10/10/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/10/2019: Publication reference added.
20/05/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
24/08/2018: The main contact has been updated from Shan Gray to Nelly Owino in the contact details and plain English summary
08/08/2018: The recruitment end date was changed from 30/06/2018 to 13/06/2018
26/07/2018: Publication reference added.
05/07/2018: The following changes have been made:
1. A publication and dissemination plan has been added.
2. An intention to publish date has been added.
04/05/2018: The following changes have been made:
1. The overall trial end date has been changed from 31/08/2017 to 31/01/2019.
2. The participant exclusion criteria have been changed.
3. The recruitment start date has been changed from 01/09/2015 to 29/02/2016.
4. The recruitment end date has been changed from 31/08/2017 to 30/06/2018.
