COMPLETE Study
Research type
Research Study
Full title
A study to evaluate the concentrations of maternal procalcitonin, plasma lactate, serum C-reactive protein and white cell count following normal and operative delivery
IRAS ID
227880
Contact name
Katrine E Orr
Contact email
Sponsor organisation
University of Dundee / NHS Tayside
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Sepsis occurs when a person’s immune system is overwhelmed by infection causing vital organ systems such as the kidneys, lungs and heart to fail. Sepsis is a leading cause of pregnancy related death in the UK and globally. Delays in diagnosing and treating maternal sepsis contribute to maternal death.
It has become routine practice to use lactate and C-reactive Protein (CRP) blood tests to aid in the diagnosis of sepsis during labour and following childbirth, however, these blood tests may be of limited value in diagnosing sepsis. Procalcitonin (PCT) may be a better test to detect or exclude sepsis as it remains low during normal labour and shortly after childbirth. It is also known that other sources of inflammation such as major surgery may cause a rise in PCT but we do not know if caesarean section or operative vaginal birth (usually forceps) provoke a rise in PCT.
This study aims to calculate reference ranges for PCT, lactate, CRP and white cell count on day 1 following normal birth, planned caesarean section, caesarean section in labour and operative vaginal birth in women who do not have sepsis. A total of 480 mothers will be recruited with 120 in each group.
PCT, lactate, CRP and white cell count will be measured on day one following delivery. These blood tests will be performed alongside routine blood tests and will not require any additional needles. Pregnant women will be given written information about the study at their 20 week antenatal appointment and will have the opportunity to ask questions.
A better understanding of the effect that operative birth has on these markers will facilitate the early diagnosis and treatment of women with sepsis. This may also reduce the number of women who are prescribed antibiotics unnecessarily.REC name
West of Scotland REC 1
REC reference
17/WS/0097
Date of REC Opinion
6 Jun 2017
REC opinion
Further Information Favourable Opinion