ExPeDITe: Ectopic Pregnancy DIagnosis sTudy
Research type
Research Study
Full title
Ectopic Pregnancy DIagnosis sTudy: Developing metabolomics profile analysis in biofluids to detect an ectopic pregnancy in symptomatic women in early pregnancy
IRAS ID
231379
Contact name
Dharani Hapangama
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
A pregnancy located outside of the uterine cavity complicates approximately 1 in 100 of all pregnancies, and is defined as an ectopic pregnancy. The incidence of ectopic pregnancy has remained stable over the last 25 years yet; the condition remains a health scourge, due to the significant morbidity and maternal mortality (0.2 per 1000 ectopic pregnancies in the UK) associated with it. In addition, difficulty in excluding an ectopic pregnancy in patients with the common early pregnancy symptoms such as pain and bleeding results in many unnecessary emergency surgical procedures (laparoscopies) during the first trimester of pregnancy (Condous, Okaro et al. 2005). The accurate identification of an ectopic pregnancy remains a major challenge for the clinician, and improvement in diagnostic techniques will prevent primarily the potentially lethal complication of catastrophic internal bleeding associated with an ectopic pregnancy, but also will prevent unnecessary interventions such as internal ultrasound scans (USS), blood tests, hospital admissions and invasive surgery thus reducing the related undue safety concerns and financial burden.
AIMS: to evaluate the differences in the end products (metabolites) of the compounds produced by early pregnancies that are inside the womb (intra-uterine) or outside of the womb (ectopic) in blood, urine and vaginal secretion samples by using NMR metabolomics analysis.
OUTCOME MEASURES: The primary outcome: identifying a specific set of distinguishable metabolites that are produced by an intra-uterine pregnancy interacting with the pregnant endometrium (decidua). Secondary outcome will include to assess the efficacy of NMR metabolomics in diagnosing an ectopic pregnancy against the current diagnostic algorithm.
POPULATION ELIGIBILITY: All pregnant women with pain and or bleeding and less than 10 weeks of gestation, attending the emergency room (ER) at Liverpool Women’s Hospital (LWH).
DURATION: recruitment 24 months, data analysis further 12 months, 36 months in total.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0646
Date of REC Opinion
5 Jan 2018
REC opinion
Further Information Favourable Opinion