Clinical effect of antithrombin concentrate treatment on uterine blood flow and the amount of Atenativ needed to maintain a normal antithrombin level during two weeks in early and severe preeclampsia

• Conditions: Early and severe preeclampsia with low antithrombin activity.; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-005770-57-SE
• Lead Sponsor: department of OBstetrics, Sahlgrenska university hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-27
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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 < 600 ml/24 h, coagulation disturbancies.
3. AT level <0.8 kIE/LC

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified