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NCT Number: NCT06217913

Effects of Monitoring Blood Pressure During Pregnancy

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.

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Key information

Conditions

Birth Weight Body Weight Body Weight Changes Body-Weight Trajectory Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain Trajectory

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200092, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wearable device to monitor the blood pressure

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.

Primary outcomes

  1. Offspring weight change

    Time frame: 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 outcomes

  1. Maternal blood pressure change

    Time frame: 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.

  2. Maternal complications

    Time frame: 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.

  3. Offspring outcomes

    Time frame: 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.

  4. Offspring neurodevelopment

    Time frame: up to 24 months

    Assessing neurodevelopment using ASQ scores or Bayley scores.

  5. Offspring perinatal outcomes

    Time frame: 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.

Other outcomes

  1. metabolomics

    Time frame: 16 weeks

    Meteranl metabolomics during pregnancy (around gestational age at 12 weeks and 28weeks) would be measured in pg/ml.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongying Zhao, MD,PhD

CONTACT

[email protected]

25078395

Yongjun Zhang, MD,PhD

CONTACT

[email protected]

25078395

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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