Effects of Monitoring Blood Pressure During Pregnancy

Not Applicable

Not yet recruiting

• Conditions: Birth Weight; Weight Gain Trajectory
• Interventions: Device: wearable device to monitor the blood pressure

• Registration Number: NCT06217913
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Study Start: 2024-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	wearable device to monitor the blood pressure	routine delivery examination group + use of wearable blood pressure monitoring device group

Primary Outcome Measures

Name	Time	Method
Offspring weight change	up to 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Maternal complications	28 weeks	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.
Offspring neurodevelopment	up to 24 months	Assessing neurodevelopment using ASQ scores or Bayley scores.
Offspring perinatal outcomes	up to 24 months	Including the incidence of mortality, large for large for gestational age infants and small for gestational age infants, which would be stated in percentages.
Offspring outcomes	up to 24 months	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.
Maternal blood pressure change	16 weeks	24-hour weekly blood pressure and its fluctuation in pregnant women from 12 to 20 weeks of gestation would be measure in mmHg.

Trial Locations

Locations (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China