Effects of Monitoring Blood Pressure During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: wearable device to monitor the blood pressure.
- Who it may be relevant to
- Registry conditions: Birth Weight, Weight Gain Trajectory. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Monitoring Blood Pressure in High-risk Pregnant Women Using a Wearable Device
Overview
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.
Interventions
- Device wearable device to monitor the blood pressure
Pregnant women began to establish antenatal examination records (usually before 12 weeks of pregnancy), and were enrolled through randomized grouping. Pregnant women in the intervention group were provided with wearable blood pressure monitoring equipment, and ambulate blood pressure monitoring was conducted for at least 2 24 hours per week from 12 weeks of pregnancy until 28 weeks of pregnancy, after which blood pressure monitoring was carried out according to routine antenatal examination.
Primary outcome measures
- Offspring weight change [Time frame: up to 24 months]
Secondary outcome measures (5)
- Maternal blood pressure change [Time frame: 16 weeks]
- Maternal complications [Time frame: 28 weeks]
- Offspring outcomes [Time frame: up to 24 months]
- Offspring neurodevelopment [Time frame: up to 24 months]
- Offspring perinatal outcomes [Time frame: up to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06217913 · XH-23-010