Condition category
Pregnancy and Childbirth
Date applied
23/09/2015
Date assigned
23/09/2015
Last edited
24/08/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Ms Nelly Owino

ORCID ID

Contact details

NPEU Clinical Trials Unit
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Headington
OX3 7LF
United Kingdom

Additional identifiers

EudraCT number

2015-000872-89

ClinicalTrials.gov number

Protocol/serial number

19501

Study information

Scientific title

ANODE: A randomised controlled trial of prophylactic Antibiotics to investigate the prevention of infection following Operative vaginal Delivery

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

15/SC/0442

Study design

Randomised; Interventional; Design type: Not specified, Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

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

01/09/2015

Overall trial end date

31/01/2019

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

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

29/02/2016

Recruitment end date

13/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NPEU Clinical Trials Unit
National Perinatal Epidemiology Unit (NPEU) University of Oxford Old Road Campus
Headington
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Nuffield Department of Obstetrics & Gynaecology
Level 3
Women's Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

Intention to publish date

30/06/2019

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30041702

Publication citations

Additional files

Editorial Notes

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.