Preeclampsia Pregnancy and Childbirth Preeclampsia
Conditions
Interventions
The subjects are enrolled among women who visit antenatal clinics at Hyvinkää Hospital, Helsinki, Tampere and Kuopio University Hospitals, Tampere City Hospital, Päijät-Häme, Joensuu and Iisalmi Hospi
Sponsors
Academy of Finland (Finland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria (one of the following): 1. Preeclampsia in a previous pregnancy 2. IUGR in a previous pregnancy 3. Essential hypertension 4. Gestational diabetes in a previous pregnancy 5. Diabetes mellitus type 1 6. Previous pregnancy with fetal demise (> 22 gestational weeks or over 500 g) 7. Body Mass Index (BMI) greater than 30 kg/m^2 prior to pregnancy 8. Age younger than 20 or older than 40 years at the day of admission 9. Systemic Lupus Erythematosus (SLE) 10. Sjögren's syndrome Definitions for inclusion criteria: 1. Preeclampsia is defined as de novo hypertension and proteinuria. Proteinuria is defined as presence of 0.3 g/day or more of protein in a 24-hour urine specimen 2. IUGR is defined as birth weight below -2 standard deviations below mean for sex and gestational age according to Finnish standards 3. Essential hypertension is defined as systolic blood pressure 140 mmHg or more and diastolic blood pressure 90 mmHg or more before 20th gestational week or medication for blood pressure 4. Gestational diabetes is defined by one or more abnormal values in two-hour oral glucose tolerance test Subjects invited to participate in the study will be given written and oral information about the study. Each participant will sign an informed consent.
Exclusion criteria
Exclusion criteria: 1. Asthma (diagnosed by a physician) 2. Allergy to ASA 3. Tobacco smoking (during pregnancy) 4. Previous peptic ulcer 5. Previous placental ablation 6. Inflammatory bowel diseases (Crohn´s disease, colitis ulcerosa) 7. Rheumatoid arthritis 8. Hemophilia or trombophilia (previous venous or pulmonary thrombosis and/or coagulation abnormality) 9. Gestational weeks less than 12th more than 14th 10. Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gestational weeks of 12th to 14th: 1.1. Women?s weight and blood pressure 1.2. Ultrasound examination (Doppler velocimetry) 1.3. Blood for biochemical and genetic analysis (30 ml) 1.4. Urine (10 ml) 1.5. Randomisation for the ASA and placebo groups 2. Gestational weeks of 18th to 20th and 26th to 28th : 2.1. Weight and blood pressure measurements are repeated 2.2. Ultrasound examinations (Doppler velocimetry) 2.3. Fasting blood (30 ml) and urine (10 ml) samples 2.4. A 2-hour oral glucose tolerance test (only at 26th to 28th weeks of gestation) 3. At delivery: 3.1. Information collected from the clinical records of the mother and the newborn 3.2. Blood (30 ml) and urine (10ml) samples 3.3. Cord blood sample 4. Biochemical measurements: samples are obtained at 12th to 14th, 18th to 20th and 26th to 28th weeks of gestation and within 12-24 hours after delivery. The biochemical measurements include: 4.1. Indices of antioxidant status: serum uric acid (enzymatic assay using uricase) 4.2. Indices of placental insufficiency: 4.2.1. Serum activin A 4.2.2. Inhibin A and B (two site enzyme immunoassay) 4.2.3. Serum leptin (Radioimmunoassay [RIA] or Enzyme-Linked Immunosorbent Assay [ELISA]) 4.2.4. Serum Flt1 (ELISA) 4.3. Indices of endothelial function: 4.3.1. Serum asymmetric dimethylarginine (ADMA) 4.3.2. Serum fibronectin (ELISA) 4.3.3.Serum e-selectin (ELISA) 4.3.4. Serum c-reactive protein (immunotubidimetry or immunonefelometry) 4.4. Lipids: 4.4.1. Serum triglyserides (enzymatic) 4.4.2. Serum free fatty acids (enzymatic) 4.5. Glucose metabolism: 4.5.1. Serum insulin (RIA) 4.5.2. Serum glucose (enzymatic) 4.5.3. 2-hour glucose tolerance test 4.5.4. Serum Sex Hormone-Binding Globulin (SHBG) (Time-Resolved Fluorescence Immunoassay [TR-FIA]) 4.6. Biochemical measurements from the cord blood 5. The biochemical compounds to be measured in the study population include: 5.1. Insulin- insulin-like growth factor system: 5.1.1. Serum insulin ( | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To test whether infants born to mothers with preeclampsia are characterized by greater behavioral difficulty in emotional, social and cognitive domains of development than infants born to mothers without preeclampsia. The aim is also to test whether infant developmental outcomes are predicted by maternal prenatal stress, depression and anxiety measured and the mother?s stress-predisposing / buffering traits and characteristics, together or independently of preeclampsia and potential postnatal environmental factors. 2. Healthcare register study We collect data from the following sources: 2.1. National Population Register: to identify the parents and siblings (including half-siblings) 2.2. Medication reimbursement: hypertension, coronary heart disease, cardiac insufficiency, diabetes, asthma, death register (time and cause of death) 2.3. Hospital diagnosis register: diagnosis related to cardiovascular disease and obstetrics 2.4. Birth register: birth measurements, gestational age and possible pre- and postnatal complications of siblings and half-siblings of newborn infant 2.5. Hospital records of the women and their mothers: pregnancy follow-up and newborn 2.6. Permission to collect and link the data applied by the Ministry of Social and Health Affairs | — |
Countries
Finland
Outcome results
None listed