Effects of Monitoring Blood Pressure in High-risk Pregnant Women Using a Wearable Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Offspring weight change
Study Overview
Brief Summary
In this study, at least 400 women with high-risk of pregnancy hypertension will use a wearable device to monitor the blood pressure during gestational age from 12 weeks to 28weeks. The observed outcomes including maternal and offspring. Participants were from three hospital including Shanghai Xinhua Hospital, Jiaxing Maternal and Child Health Hospital and Peking University Third Hospital. Pregnant women were randomly divided into control group (routine delivery examination group) and intervention group (routine delivery examination group + use of wearable blood pressure monitoring device group), 200 cases each.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women with a single pregnancy before 12 weeks of pregnancy
- •The presence of any of the following risk factors: age > 30 years, a history of eclampsia, a family history of eclampsia, obesity (BMI ≥ 30 Kg/m2), and a history of gestational hyperglycemia (pregestational type 1 and type 2 diabetes; gestational manifest diabetes and gestational diabetes requiring insulin treatment), preexisting chronic hypertension, kidney disease, and autoimmune diseases such as systemic lupus erythematosus and antiphospholipid syndrome.
- •Signed the informed consent can be continuously followed up.
- •Permanent population living in the study area.
- •All subjects received routine antenatal examination and treatment.
Exclusion Criteria
- •Termination of pregnancy before 20 weeks
- •Withdraw from the study
- •Lost visitors
Arms & Interventions
control group
routine delivery examination group
intervention group
routine delivery examination group + use of wearable blood pressure monitoring device group
Intervention: wearable device to monitor the blood pressure (Device)
Outcomes
Primary Outcomes
Offspring weight change
Time Frame: up to 24 months
The offspring would be followed up from birth to 2 years of age at 42days, 3, 6, 12, 18 and 24 months of birth. Birth weights and weights would be measure in kilograms. The primary outcome the growth curve of the follow-up weights.
Secondary Outcomes
- Maternal complications(28 weeks)
- Offspring neurodevelopment(up to 24 months)
- Offspring perinatal outcomes(up to 24 months)
- Offspring outcomes(up to 24 months)
- Maternal blood pressure change(16 weeks)