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A prospective randomized controlled clinical study on remote blood pressure monitoring combined with remote fetal monitoring and outpatient monitoring in patients with preeclampsia

A prospective randomized controlled clinical study on remote blood pressure monitoring combined with remote fetal monitoring and outpatient monitoring in patients with preeclampsia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088945
Enrollment
Unknown
Registered
2024-08-29
Start date
2023-07-15
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal-Fetal Medicine

Interventions

Remote monitoring group:Remote monitoring group (1) Remote blood pressure monitoring: After being taught by outpatient nurses, patients can use their own blood pressure monitoring system every morning
? Remote fetal heart rate monitoring:? A dedicated person will guide pregnant women and their families to use a remote fetal heart rate monitor Ensure that pregnant women not only undergo routine pren
control group:(1) Outpatient observation: Patients are required to undergo a blood pressure measurement at a fixed time during the prenatal examination (routine prenatal examination once every 2 weeks

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Analyze and evaluate the effectiveness and safety of remote blood pressure monitoring combined with remote fetal monitoring for monitoring preeclampsia patients during pregnancy, and determine whether this technology can replace and outperform the traditional management method of outpatient monitoring for preeclampsia patients. 2. Research and develop corresponding regulatory standards to improve pregnancy outcomes while minimizing hospital admissions, saving time and costs, and providing patient convenience, in order to ensure the safety of mother and fetus for preeclampsia patients. 1. Adult pregnant and postpartum women (= 18 years old); If the gestational age is = 30 weeks and = 36 weeks, the informed consent form of the patient shall be signed. 2. Diagnostic criteria: After 20 weeks of pregnancy, blood pressure increases, systolic blood pressure is greater than or equal to 140mm Hg, and/or diastolic blood pressure is greater than or equal to 90mm Hg, accompanied by 24-hour urine protein quantification greater than 0.3g or random urine protein (+) or combined with thrombocytopenia, liver function damage, renal function damage, pulmonary edema, newly occurring central nervous system abnormalities or visual impairment. 3. Single or twin pregnancy.

Exclusion criteria

Exclusion criteria: 1) Severe preeclampsia 2) Diagnosed with cardiovascular and cerebrovascular diseases before pregnancy 3) Individuals with mental illness 4) have communication barriers 5) Patients with severe metabolic diseases 6) Patients with immune diseases 7) Patients with concomitant coagulation dysfunction 8) Patients with incomplete clinical data 9) Those with poor compliance

Design outcomes

Primary

MeasureTime frame
Incidence of adverse outcomes in newborns;

Secondary

MeasureTime frame
Maternal complications;

Countries

China

Contacts

Public ContactYao Runsi

Shenzhen Second People's Hospital

mao0413@126.com+86 135 9011 9271

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026