Status:
WITHDRAWN
Atenativ Effect on Uterine Blood Flow and Preeclampsia
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Octapharma
Conditions:
Antithrombin III Deficiency
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The study will be an open controlled pilot study of 6 patients with early-onset severe preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients will be followed up...
Detailed Description
The study will be an open controlled pilot study of 6 patients with early-onset severe preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients will be followed up...
Eligibility Criteria
Inclusion
- Pregnant woman in gestational week 23+0 - 29+0
- 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 \< 600 ml/24 h, coagulation disturbancies.
- AT level \<0.8 kIE/L
- \-
Exclusion
- History of congenital AT deficiency 2. Severe preeclampsia with demand on acute delivery within 24 hours according to the investigators judgments 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
- \-
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02278575
Start Date
January 1 2016
End Date
May 1 2017
Last Update
September 26 2017
Active Locations (1)
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1
Dept Obstetrics, Sahlgrenska University Hospital
Gothenburg, Sweden, 41685