Effects of Monitoring Blood Pressure During Pregnancy

NCT ID: NCT06217913

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Birth Weight Weight Gain Trajectory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

routine delivery examination group

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

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

Group Type EXPERIMENTAL

wearable device to monitor the blood pressure

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Dongying Zhao, MD,PhD

Role: CONTACT

Yongjun Zhang, MD,PhD

Role: CONTACT

Other Identifiers

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XH-23-010

Identifier Type: -

Identifier Source: org_study_id

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