A groundbreaking cluster randomised trial has commenced, aiming to determine the effectiveness of routine Group B Streptococcus (GBS) screening in preventing early-onset neonatal sepsis. Spanning up to 80 hospital maternity units, the study encompasses approximately 320,000 women to assess the impact of different testing strategies on newborn health outcomes.
Study Design and Methodology
Participants will be randomly assigned to either a routine GBS testing protocol or a traditional risk factor-based approach using a sophisticated web-based minimisation algorithm. Further categorization within the routine testing group involves selecting between antenatal enriched culture medium testing and intrapartum rapid testing methods. If a test yields a positive result for GBS or if maternal risk factors for early-onset GBS infection are identified, intrapartum antibiotic prophylaxis will be administered to mitigate the risk of infection in newborns.
Primary Outcomes and Data Collection
The main focus of the trial is to monitor instances of all-cause early neonatal sepsis occurring within the first seven days post-birth. This includes cases confirmed by positive blood or cerebrospinal fluid cultures, early neonatal deaths due to infection, or instances where sepsis is suspected based on clinical signs and symptoms despite inconclusive cultures, alongside subsequent antibiotic treatment. The study will also evaluate the cost-effectiveness of each strategy by calculating the incremental cost per case of sepsis avoided and per quality-adjusted life-year gained.
- Evaluating the effectiveness of routine GBS testing versus risk-based strategies.
- Assessing cost-effectiveness in preventing neonatal sepsis.
Ethical approval for the study was secured from the Derby Research Ethics Committee, ensuring that the allocated testing strategies become the standard clinical practice within participating sites. Consent for testing will be obtained verbally from women in the routine testing groups, utilizing existing National Health Service data alongside limited participant-level outcome collection.
This extensive trial promises to deliver vital insights into the prevention of early-onset neonatal sepsis through effective GBS screening protocols. The outcome will potentially shape future guidelines, optimizing both maternal and neonatal healthcare practices. Stakeholders, including healthcare providers and policymakers, stand to benefit from the economic and clinical data generated, facilitating informed decisions that enhance neonatal survival rates and overall public health strategies.
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