Effects of Monitoring Blood Pressure in High-risk Pregnant Women Using a Wearable Device
| Registry | NCT06217913 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 400 (Estimated) |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other) |
| Conditions | Birth Weight, Weight Gain Trajectory |
| Interventions | wearable device to monitor the blood pressure (Device) |
| Dates | start 2024-12-01 (estimated), primary completion 2025-12-31 (estimated), completion 2027-06-30 (estimated), first posted 2024-01-23, last updated 2024-01-23 |
| Locations | 1 site in China |
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All trials for Birth Weight All trials for Weight Gain Trajectory All trials of wearable device to monitor the blood pressure
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| control group | No intervention | routine delivery examination group | |
| intervention group | Experimental | Device: wearable device to monitor the blood pressure | routine delivery examination group + use of wearable blood pressure monitoring device group |
Sex: Female, ages: 18 Years to 60 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai Municipality | China |