PKPD Study
Research type
Research Study
Full title
How pregnant women’s bodies process benzylpenicillin given to prevent Group B streptococcal infections in an infant’s first week of life.
IRAS ID
259853
Contact name
Kate Navaratnam
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Background: Group B streptococci (GBS) are bacteria that exist harmlessly in up to 40% of pregnant women’s vaginas. During childbirth babies can pick up the bacteria and some will develop infections. GBS are the commonest cause of severe infections in babies first week of life and babies may die or become severely disabled. In the UK, women thought to be at risk of passing on GBS to their babies are offered antibiotics to reduce the risk. Benzylpenicillin is an antibiotic injected into the mother’s veins during labour, despite this some babies develop infections. The doses given and the timing of doses come from early clinical trials in the 1980’s. The first step to finding ways to improve how benzylpenicillin is used to prevent GBS is understanding how pregnant bodies process it.
Aim: To use specialised knowledge and technology to how understand pregnant women’s bodies process doses of benzylpenicillin
Methods: This study will take place in Liverpool Women’s Hospital. We will ask pregnant women requiring benzylpenicillin in labour to prevent GBS if they wish to take part. 30 women will be included and receive benzylpenicillin every four hours during labour (normal care in the UK). We will measure benzylpenicillin levels in their blood to understand how they process benzylpenicillin and how to achieve the best levels to kill GBS. Women with high temperatures in labour or penicillin allergy will not be able to take part as they will need different antibiotics. We will take a maximum of six small blood samples from women in labour. We will use careful study design to make sure blood samples are timed to provide maximum information about how women are processing benzylpenicillin. After delivery, we will take umbilical cord blood and placental samples to measure benzylpenicillin levels that have travelled to the baby
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0300
Date of REC Opinion
27 Jun 2019
REC opinion
Further Information Favourable Opinion