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Table 1 REMOTE CONTROL trial inclusion and exclusion criteria

From: Remote blood pressure monitoring in high risk pregnancy — study protocol for a randomised controlled trial (REMOTE CONTROL trial)

 

Definition

Inclusion criteria

 Age ≥ 18 years

 

 Able to provide informed consent

 

 Able and willing to follow instructions for use of automated BP machine and app-based system

 

 Chronic kidney disease

Abnormalities of kidney structure or function (either reduced GFR < 90 ml/min/1.73 m2, albuminuria or proteinuria) present prior to pregnancy

 Autoimmune disorder

Diagnosis of an autoimmune condition such as systematic lupus erythematosus prior to pregnancy

 Type 1 or type 2 diabetes mellitus

 

 Chronic hypertension

Systolic BP > 140 mmHg or diastolic BP > 90 mmHg on at least 2 occasions prior to 20 weeks’ gestation

 Previous pregnancy complicated by HDP or diagnosis of gestational hypertension this pregnancy

Previous HDP includes chronic hypertension, gestational hypertension, preeclampsia, or preeclampsia superimposed on chronic hypertension

Gestational hypertension (Systolic BP > 140 mmHg or diastolic BP > 90 mmHg on at least 2 occasions after 20 weeks’ gestation)

 Confirmation of viable intrauterine pregnancy on dating scan

 

 IVF pregnancy

 

 High-risk for developing preeclampsia on first-trimester screening

Reported risk of < 1:100 of developing preeclampsia on commercially available combined first-trimester screening tests

 Before 28 weeks gestation

 

Exclusion criteria

 Participants who have signs of preeclampsia on initial evaluation

Preeclampsia (BP reading > 140 mmHg and/or 90 mmHg on at least 2 occasions after 20 weeks’ gestation accompanied by evidence of end-organ involvement)

 Multifoetal pregnancy

 

 Lethal foetal abnormality

Lethal foetal chromosomal, genetic or morphological abnormality detected on screening tests

 Inability to access or use the app-based system

 

 Unable to consent

 

 Non-English speaking background not supported by the mobile application

 
  1. GFR glomerular filtration rate, SLE systemic lupus erythematosus, BP blood pressure, HDP hypertensive disorder of pregnancy