NCT06217913

Effects of Monitoring Blood Pressure During Pregnancy

Effects of Monitoring Blood Pressure in High-risk Pregnant Women Using a Wearable Device

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Birth Weight
• Weight Gain Trajectory

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2027-06-30
• First posted: 2024-01-23
• Last updated: 2024-01-23

Locations

1 site across 1 country: China