Systemic markers for women with idiopathic recurrent pregnancy loss
Research type
Research Study
Full title
DETERMINATION OF A PANEL OF SYSTEMIC MARKERS FOR WOMEN WITH RECURRENT PREGNANCY LOSS (RPL) OF UNKNOWN (IDIOPATHIC) CAUSE. (A PILOT STUDY)
IRAS ID
194834
Contact name
Robert Reilly
Contact email
Sponsor organisation
University of the West of England, Bristol
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
Approximately 15% of all clinically recognised pregnancies are lost, with 2-3% representing recurrent pregnancy loss (RPL; two or more losses with or without previous live births). About 50% of RPL are due to genetic abnormalities, the cause of the rest remains unknown. Preliminary evidence in the literature suggests an increased tendency towards blood clotting (thrombosis) in affected women, but data and drug treatment for this provides inconsistent outcomes, suggesting there are more factors involved.
We hypothesize that a combination of biological pathways related to clotting can influence pregnancy outcome. We suggest that subtle imbalances in control of the immune system and blood clotting collectively can result in premature labour, and consequent loss of pregnancy.
This study will explore biological markers in blood samples from women outside of pregnancy with RPL record, compared with control women who have had uncomplicated pregnancies. The aim is to identify either a novel marker, or combination of blood markers that can be used to estimate “RPL risk”, such that appropriate clinical interventions can be performed, and provide a better understanding of why RPL of unknown cause occurs.
Clinicians will select and invite women with two or more consecutive pregnancy losses (case group) versus women who have had normal healthy pregnancies (control group) to take part in the study. Women will be recruited over 18 months and a 20ml blood sample taken. The blood will be analysed for markers of whole blood clotting, together with levels of immune cells. DNA samples will be used to predict higher and lower inflammatory responses. Participants will also complete a questionnaire addressing lifestyle factors that may also play a role in RPL. Responses to the questionnaire, blood test measurements together with health and physical factors such as age, BMI etc. will be statistically analysed to create an algorithm of risk for RPL.REC name
London - Bloomsbury Research Ethics Committee
REC reference
19/LO/1264
Date of REC Opinion
12 Nov 2019
REC opinion
Further Information Favourable Opinion