Condition category
Pregnancy and Childbirth
Date applied
23/09/2015
Date assigned
23/09/2015
Last edited
14/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
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?
Mrs Shan Gray

Trial website

Contact information

Type

Public

Primary contact

Mrs Shan Gray

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 measures

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

31/08/2017

Reason abandoned

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

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

01/09/2015

Recruitment end date

31/08/2017

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes