Early and severe preeclampsia with low antithrombin activity.
Conditions
Interventions
Trade Name: Atenativ ( antithrombin concentrate)
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Sponsors
department of OBstetrics, Sahlgrenska university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with severe early-onset preeclampsia during gestational week 23-29+0. 2. Severe preeclampsia as defined by international criteria (1,2) • Blood pressure >160/110 mmHg (measured twice 30 minutes apart). proteinuria (>5 .0 g/L per 24 hours or >3 + labstick in at least two random samples six hours apart) after 20th gestational week. • Blood pressure >140/90 mmHg and proteinuria >5.0 g/24 h. • preeclampsia ( blood pressure > 140/90 and proteinuria >0.3 g/24 h) with IUGR or subjective symptoms as epigastic pain (HELLP), headache, dizziness or visual disturbancies, oligouri =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of congenital AT deficiency 2. Severe preeclampsia with demand on acute delivery within 24 hours according to the investigators judgement 3. Concomitant administration of anticoagulants and platelet inhibitors within 2 weeks 4. Chronic renal disease 5. Diabetes melittus or gestational diabetes 6. Intrauterine fetal death 7. Participation in another clinical study 8. Multiple pregnancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study blood flow in uterine artery duirng infusion of Atenativ and to study how myck Atenativ has to be administered to maintain normal antithrombin activity during two weeks.;Secondary Objective: Secondary the outcome of pregnancy and neonatal status will be studied.;Primary end point(s): Blood flow in a uterine artery during infusion of Atenativ Amount Atenativ needed to maitain normal antithrombin activity during twp weeks from inclusion.;Timepoint(s) of evaluation of this end point: During infusion of Atenativ | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Outcome of pregnancy and neonatal status;Timepoint(s) of evaluation of this end point: After delivery | — |
Countries
Sweden
Contacts
Public ContactMargareta Hellgren
department of Obstetrics, Gothenburg
Outcome results
None listed