Effects of Monitoring Blood Pressure During Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Termination of pregnancy before 20 weeks
Withdraw from the study
Lost visitors
Trial design
Design model
Parallel
Treatments tested in this trial
wearable device to monitor the blood pressure
DevicePregnant 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: control groupNo intervention 0 interventions
Group B: intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 24 monthsSecondary outcomes
1
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.
Time frame
16 weeks2
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.
Time frame
28 weeks3
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.
Time frame
up to 24 months4
Offspring neurodevelopment
Assessing neurodevelopment using ASQ scores or Bayley scores.
Time frame
up to 24 monthsOther outcomes
1
metabolomics
Meteranl metabolomics during pregnancy (around gestational age at 12 weeks and 28weeks) would be measured in pg/ml.
Time frame
16 weeksSponsors and contacts
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Source ClinicalTrials.gov
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