NCT06217913

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Dec 2024Jun 2027

First Submitted

Initial submission to the registry

August 25, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

January 23, 2024

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

August 25, 2023

Last Update Submit

January 11, 2024

Conditions

Birth WeightWeight Gain Trajectory

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Maternal blood pressure change

    16 weeks

  • Maternal complications

    28 weeks

  • Offspring outcomes

    up to 24 months

  • Offspring neurodevelopment

    up to 24 months

  • Offspring perinatal outcomes

    up to 24 months

Other Outcomes (1)

  • metabolomics

    16 weeks

Study Arms (2)

control group

NO INTERVENTION

routine delivery examination group

intervention group

EXPERIMENTAL

routine delivery examination group + use of wearable blood pressure monitoring device group

Device: wearable device to monitor the blood pressure

Interventions

wearable device to monitor the blood pressureDEVICE

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.

intervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Termination of pregnancy before 20 weeks
  • Withdraw from the study
  • Lost visitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Birth WeightBody-Weight Trajectory

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Central Study Contacts

Dongying Zhao, MD,PhD

CONTACT

25078395zdy0056374@aliyun.com

Yongjun Zhang, MD,PhD

CONTACT

25078395zhangyongjun@sjtu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

January 23, 2024

Study Start

December 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2027

Last Updated

January 23, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)