Prediction of early pregnancy viability
Research type
Research Study
Full title
Prediction of early pregnancy viability in pregnancies of uncertain viability on ultrasound scan.
IRAS ID
172650
Contact name
Obianuju Nzelu
Contact email
Sponsor organisation
The Research & Development Office, King's College Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Ultrasound is the accepted diagnostic tool in the assessment of early pregnancy complications. Conclusive diagnosis of miscarriage cannot always be achieved on one scan and as such the majority of women require a follow-up visit to assess pregnancy viability. In the period between scans women are often left with uncertainty regarding their pregnancy outcome.
Previously, models have been developed to predict the viability of early pregnancies when no embryo has been visible on ultrasound scan. These models used biochemical, clinical and ultrasonographic parameters to provide a probability score for pregnancy viability after initial scan.
Recent changes in the ultrasonographic criteria used to diagnose miscarriage have led to an increase in the number of patients requiring a second scan to assess viability. Although this approach reduces diagnostic errors, it increases the number of visits and may increase patient anxiety, clinical work load and cost.
The main study objective is to assess whether biochemical and clinical parameters can be combined with ultrasound findings to predict pregnancy viability after a single scan.
The study will be undertaken at the Early Pregnancy Unit, King’s College Hospital. Participants will be followed up until either a diagnosis of viable or non-viable pregnancy is established.
Patients will present for the first time in this pregnancy either as self-referral, via general practice, the inpatient ward or A&E. If they have a pregnancy of uncertain viability on ultrasound scan, they will be offered a place in the study; written consent will be obtained. Measurements of serum β-hCG and progesterone will be taken at the initial ultrasound scan.
The study will be undertaken in two phases; an initial test group will be recruited in order to develop the model for predicting pregnancy viability, and subsequently a separate group will be recruited in order to validate the predictive power of the model.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0214
Date of REC Opinion
25 Sep 2015
REC opinion
Further Information Favourable Opinion