Overview

Atenativ Effect on Uterine Blood Flow and Preeclampsia

Status:
Withdrawn
Trial end date:
2017-05-01
Target enrollment:
0
Participant gender:
Female
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 within the study until three days after delivery. Laboratory analyses and uterine and umbiliacal blood flow will be determined.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vastra Gotaland Region
Collaborator:
Octapharma
Treatments:
Antithrombin III
Antithrombins
Criteria
Inclusion Criteria:

1. Pregnant woman in gestational week 23+0 - 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/L

-

Exclusion Criteria:1. 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

-