An interventional study of wearable device to monitor the blood pressure in Birth Weight and Weight Gain Trajectory, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Supportive care
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.
185 studies on the registry are indexed under Birth Weight; 25 are open to participants now.
This study's planned enrollment of 400 is above the median of 170 across 117 interventional studies indexed under Birth Weight.
Browse Birth Weight studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
routine delivery examination group
routine delivery examination group + use of wearable blood pressure monitoring device group
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.
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 months
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 weeks
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 weeks
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 months
Offspring neurodevelopment
Assessing neurodevelopment using ASQ scores or Bayley scores.
Time frame: up to 24 months
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.
Time frame: up to 24 months
metabolomics
Meteranl metabolomics during pregnancy (around gestational age at 12 weeks and 28weeks) would be measured in pg/ml.
Time frame: 16 weeks
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →