Can kisspeptin be used to predict pregnancy outcome?
Research type
Research Study
Full title
Can kisspeptin be used to predict pregnancy outcome?
IRAS ID
277424
Contact name
Wassif S Wassif
Contact email
Sponsor organisation
Bedfordshire Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Can kisspeptin be used to predict pregnancy outcome?
This study aims to determine whether specific proteins in blood or urine correlate with health of pregnancy. Publications suggest a protein called kisspeptin produced by the placenta is associated with miscarriage and insulin resistance, thus we wish to determine whether levels are associated adverse maternal or foetal events such as miscarriage, diabetes or foetal size. If an association between kisspeptin and pregnancy outcome was demonstrated, this could be used to identify women at higher risk, allowing closer observation and the potential for future trials into optimal management.
All pregnant ladies under the care of Bedford Hospital who are over the age of 18 years old and are able to give consent, presenting both at their routine antenatal booking appointment or at the hospital Early Pregnancy Assessment Unit (EPAU) will be eligible for recruitment, representing low and high risk cohorts, respectively. We will recruit 600 patients to ensure we get sufficient representation of both normal viable pregnancies and those with complications, to ensure the trial is statistically valid.
The remainder of blood and urine samples taken for routine care will be used where possible. EPAU patients may require samples to be taken specifically for this study if not needed for their routine care; samples will be taken at first presentation and also at subsequent visits if they require these follow up appointments. Demographics and medical history of patients will be collected from the booking forms, and pregnancy outcome and foetal and maternal complications from the patients’ medical records. This study fits into their normal treatment, so there are no extra clinic visits or interventions above those of their routine care. The study will follow participants until the end of their pregnancies. Recruitment is anticipated to last 6 months.REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0126
Date of REC Opinion
12 May 2020
REC opinion
Favourable Opinion