Strategies to reduce vertical transmission of multi-drug resistant pathogens to neonates
Prof Mike Sharland is the CI, Dr Julia Bielicki and Dr Emily Beales are co-investigators
Medical Research Council
St George’s University London
Type of Study
Observational, RCT, Interventional, Phase I.
Hospital antenatal ward, labour ward, postnatal ward and neonatal unit in Zomba Central Hospital in Malawi
Maternal strata: Women presenting in labour at any gestation with or without rupture of membranes.
Neonatal strata: Neonates born in hospital within the last 12 hours, weighing >1000g and not born to enrolled women.
This is a pilot study to assess the best way to apply antiseptic to mothers in labour and new born babies. The antiseptic aims to reduce the amount of potentially harmful bacteria on the skin of new born babies. Reducing the bacteria might be useful for preventing infections which are transmitted from mother to baby during and after labour.
This study aims to find out the best type and concentration of antiseptic to use, as well as how often it should be applied and whether it should be applied to the genital tract of women in labour or to the skin of new born babies. In this pilot study, we will investigate the amount of bacteria babies have on their skin and women have in their genital tract, and look carefully at whether, and how often, skin reactions to antiseptic occur.
The antiseptics we will test in this study are called chlorhexidine and octenisept. Chlorhexidine has been used widely across the world for many decades to reduce the risk of babies dying from infection. For example, it is put on the umbilical cord of newborn babies at home in areas with high rates of deaths from infections. It is also used in labour to clean the birth canal, including before caesarean section. Octenisept is used across Europe to clean the skin of new born babies in neonatal units and also as treatment for vaginal infection in adults.
However, we don’t know whether applying chlorhexidine or octenisept to the birth canal of women in labour or the skin of new born babies could reduce the risk of infection and death in new born babies.
March 2022 – September 2022 (expected)