The ANODE Trial
Research type
Research Study
Full title
ANODE: a randomised controlled trial of prophylactic ANtibiotics to investigate the prevention of infection following Operative vaginal DElivery.
IRAS ID
177264
Contact name
Marian Knight
Contact email
Sponsor organisation
University of Oxford
Eudract number
2015-000872-89
Duration of Study in the UK
3 years, 2 months, days
Research summary
Previous studies have shown that mothers, who have had an assisted delivery (forceps or ventouse) to help deliver the baby’s head, are at greater risk of infection following the birth of their baby. Women may be at risk of local infection at the site of their episiotomy cut or any tears which may happen when you give birth, or an infection of the bloodstream (sepsis). 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. There are concerns about over prescribing antibiotics but infections can be very serious, so this is an important question to answer. We really don't know if giving a single dose of antibiotics makes a difference. Pregnant women at full term (more than 36 weeks of pregnancy) who have had an assisted delivery will be randomly allocated (i.e. by chance, like tossing a coin) to receive an injection into a vein (intravenous) of either antibiotics or salt solution without any antibiotics. We shall determine if there are fewer infections in the mother if we give antibiotics. The study will also find out if this strategy leads to better healing and less discomfort from the wounds around the birth canal. We will find out when the woman leaves hospital whether she has had symptoms or signs of infection, and also by a follow-up phone call from a research midwife when her baby is six weeks old. We will also ask women to complete a questionnaire, either on paper, on the internet or by telephone, when the baby is six weeks old, to describe how the mother is feeling, and any problems with pain, healing or infection she has had or continues to have.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0442
Date of REC Opinion
10 Sep 2015
REC opinion
Further Information Favourable Opinion