Effects of Monitoring Blood Pressure During Pregnancy

Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06217913
• Other study ID #: XH-23-010
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: August 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Dongying Zhao, MD,PhD
• Phone: 25078395
• Email: zdy0056374[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Weight Gain
• Weight Gain Trajectory

Intervention

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.

Locations

Country	Name	City	State
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	metabolomics	Meteranl metabolomics during pregnancy (around gestational age at 12 weeks and 28weeks) would be measured in pg/ml.	16 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	Offspring neurodevelopment	Assessing neurodevelopment using ASQ scores or Bayley scores.	up to 24 months
Secondary	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