Pre-eclampsia/pregnancy Pregnancy and Childbirth Gestational [pregnancy-induced] hypertension with significant proteinuria
Conditions
Interventions
Total of 80 - 100 pregnant women with abnormal uterine perfusion, including 20 women who develop pre-eclampsia during pregnancy (cases) and 60 - 80 woman who do not develop pre-eclampsia (controls). P
Sponsors
University Hospital of Jena (Universitätsklinikum Jena) (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Abnormal uterine artery Doppler ultrasound 2. Singleton pregnancy 3. Appropriate-for-gestational-age foetus 4. 19th - 21st week of gestation 5. Healthy, normotensive gravidas 6. Women, all ages considered normal-risk pregnancy: 18 - 40 years
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in interventional clinical studies 2. Multiple pregnancy 3. Premature rupture of membrane (PROM) 4. Suspected/diagnosed infected amnion syndrome (IAS) 5. Pre-term labour/cervical incompetence 6. Foetal genopathia 7. Suspected foetal defects 8. Pre-existing maternal disease, e.g. diabetes mellitus, cardiovascular or renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of pre-eclampsia during current pregnancy. Final outcome will be assessed 6 weeks post-partum either by study doctor or attending doctor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pre-eclampsia associated complications: 1. Differentiation early onset/severe and late onset/mild pre-eclampsia 2. Intra-uterine growth restriction (IUGR) or small for gestational age (SGA) 3. Induction of preterm labour/delivery 4. Intra-uterine foetal demise (IUFD) 5. Placental abruption Final outcome will be assessed 6 weeks post-partum either by study doctor or attending doctor. | — |
Countries
Germany
Outcome results
None listed