Effects of Monitoring Blood Pressure During Pregnancy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Birth Weight; Weight Gain Trajectory
• Intervention / Treatment: Device: wearable device to monitor the blood pressure

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongying Zhao, MD,PhD; Phone Number: 25078395; Email: zdy0056374@aliyun.com
• Study Contact Backup: Name: Yongjun Zhang, MD,PhD; Phone Number: 25078395; Email: zhangyongjun@sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; routine delivery examination group
Experimental: intervention group; routine delivery examination group + use of wearable blood pressure monitoring device group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Offspring weight change	The offspring would be followed up from birth to 2 years of age at 42days, 3, 6, 12, 18 and 24 months of birth. Birth weights and weights would be measure in kilograms. The primary outcome the growth curve of the follow-up weights.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal blood pressure change	24-hour weekly blood pressure and its fluctuation in pregnant women from 12 to 20 weeks of gestation would be measure in mmHg.	16 weeks
Maternal complications	The incidence of hypertension in pregnancy, pre-eclampsia, eclampsia, placental abruption, transient ischemic attack or stroke, and HELLP syndrome, which would be stated in percentages.	28 weeks
Offspring outcomes	Including incidence such as neonatal respiratory distress syndrome, sepsis, early-onset thrombocytopenia, early-onset neutropenia, hypoglycemia, congenital hypothyroidism, bronchopulmonary dysplasia, necrotizing enterocolitis, recurrent respiratory infections, infantile wheeze etc., which would be stated in percentages.	up to 24 months
Offspring neurodevelopment	Assessing neurodevelopment using ASQ scores or Bayley scores.	up to 24 months
Offspring perinatal outcomes	Including the incidence of mortality, large for large for gestational age infants and small for gestational age infants, which would be stated in percentages.	up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
metabolomics	Meteranl metabolomics during pregnancy (around gestational age at 12 weeks and 28weeks) would be measured in pg/ml.	16 weeks

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Birth Weight; Weight Gain; Body-Weight Trajectory
• Other Study ID Numbers: XH-23-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No