Birth Weight, Weight Gain Trajectory
Conditions
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.
Interventions
DEVICEwearable 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.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Offspring neurodevelopment | up to 24 months | Assessing neurodevelopment using ASQ scores or Bayley scores. |
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| metabolomics | 16 weeks | Meteranl metabolomics during pregnancy (around gestational age at 12 weeks and 28weeks) would be measured in pg/ml. |
Countries
China
Contacts
Primary ContactDongying Zhao, MD,PhD
Backup ContactYongjun Zhang, MD,PhD
Outcome results
None listed