Effects of Monitoring Blood Pressure During Pregnancy

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Birth Weight; Weight Gain Trajectory

Treatments: Device: wearable device to monitor the blood pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06217913

XH-23-010

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

control group

No Intervention group

Description:

routine delivery examination group

intervention group

Experimental group

Description:

routine delivery examination group + use of wearable blood pressure monitoring device group

Treatment:

Device: wearable device to monitor the blood pressure