Atenativ Effect on Uterine Blood Flow and Preeclampsia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02278575
• Date of registration: 28/10/2014
• Prospective Registration: Yes
• Primary sponsor: Vastra Gotaland Region
• Public title: Atenativ Effect on Uterine Blood Flow and Preeclampsia
• Scientific title: Clinical Effect of Atenativ Treatment on Uterine Blood Flow and the Amount of Atenativ Needed to Maintain a Normal Antithrombin Lvels During Two Weeks in Early and Severe Preeclampsia
• Date of first enrolment: January 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02278575
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Sweden

Contacts

• Name: Margareta Hellgren, MD,PhD,prof
• Affiliation: department Obstetrics, Sahlgrenska University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Antithrombin III Deficiency

Intervention(s)

Drug: Atenativ

Primary Outcome(s)

Blood flow in uterin and umbilical artery [Time Frame: up to day 14]

Secondary Outcome(s)

bleeding complications [Time Frame: during pregnancy and at delivery]

fetal outcome [Time Frame: at birth]

Secondary ID(s)

EudraCT 2012-005770-57

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Octapharma