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Clinical Trials in China / NCT06217913
Starting soon Not applicable

Effects of Monitoring Blood Pressure During Pregnancy

NCT06217913 · tracked via the Priya Life Science China tracker
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2024-12-01
Last updated
2024-01-23

Condition(s) studied

Birth WeightWeight Gain Trajectory

Investigational drug(s) / intervention(s)

wearable device to monitor the blood pressure

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality

More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06217913 on ClinicalTrials.gov ↗ ← All trials in China