The Salurate Study: Validation of salivary uric monitoring for early prediction of hypertensive (high blood pressure) disorders of pregnancy

Phase 1

Conditions: Salivary uric monitoring for early prediction of hypertensive disorders of pregnancy
Pregnancy and Childbirth

Registration Number: ISRCTN17992452

Lead Sponsor: Morgan Innovation and Technology (United Kingdom)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: Female

Target Recruitment: 4000

Inclusion Criteria

1. Women, 16 years old or over with a singleton pregnancy
2. Viable intrauterine pregnancy on the 10-14 week scan
3. High risk (=1:100) of HDP as determined by the ASPRE [14] algorithm*
4. Medium risk of HDP as defined by an ASPRE risk between 1:100 and 1:300
5. Able to provide informed consent
6. Gestation at enrolment =16 weeks
*Risk assessment based on: maternal factors, Mean Arterial Pressure, Uterine Artery Pulsatility Index, maternal serum pregnancy-associated plasma protein – A and placental growth factors

Exclusion Criteria

1. Any significant medical co-morbidities which may potentially interfere with participation in or achieving the objectives of the study
2. Presence or history of severe mental illness that means the participant is unable to use Salurate independently
3. Any significant learning disability that means the participant is unable to use Salurate independently
4. Educational status or language barrier that influences capacity to use the App or understand the IFUs
5. Women who are physically incapacitated such as to make manipulation of the sampling system uncomfortable or impractical, as judged by the recruiter
6. Women who do not have access to a smartphone and/or internet data at home
7. Women who have been diagnosed with severe gingivitis or periodontal disease
8. Women who have been diagnosed with oral cancer

Contraindications
1. The potential participant suffers from severe nausea and vomiting in pregnancy.
2. The potential participant has infected, inflamed, cut/scraped or painful areas in their mouth.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical diagnosis of hypertensive disorders of pregnancy, including gestational hypertension, pre-eclampsia and chronic hypertension with superimposed pre-eclampsia. Diagnoses will be in line with ISSHP definitions, and data will be collected at the conclusion of pregnancy.

Secondary Outcome Measures

Name	Time	Method
Collected within 6 weeks of the conclusion of pregnancy:1.Small for gestation age fetus or fetal growth restriction i.e. neonates whose birth weight is less than the 10th percentile for that particular gestational age or two standard deviations below the population norms on the growth charts. Fetal growth restrictions includes evidence of placental insufficiency e.g. abnormal antenatal fetal doppler measurements2. Gestational diabetes, defined as any degree of glucose intolerance with onset or first recognition during pregnancy. Diagnosed by oral glucose tolerance test or home blood glucose monitoring3.Sampling adherence, including frequency of missed samples, dropout rate and number of ‘dry’ samples received