Atenativ Effect on Uterine Blood Flow and Preeclampsia

September 22, 2017 updated by: Margareta Hellgren, Vastra Gotaland Region

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

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

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 within the study until three days after delivery. In addition to conventional therapy, i.v. administration of Atenativ will be given in a dosage aimed to raise the plasma level of AT initially to 120% (1.2 kIU/L) The goal is to achieve and maintain plasma activity of about 100% during two weeks. The dose of Atenativ is based on the actual plasma level of AT measured 2 hours before the dose. During the first two days of treatment plasma samples will be drawn for the measurement of AT activity twice a day, once before and 12 hours after infusion in order to monitor the dosage. Thereafter and until study discontinuation AT will be measured once a day. The treatment will continue for two weeks if plasma AT III is below 100% (1.0 kIU/L).Uterine blood flow is measured before, during and after the AT infusion. Demographic data, medical history and other background data (age, weight, height, gestational week, smoker or not, gravidity, parity, previous hypertension, previous medication etc) will be recorded in order to ensure that the inclusion criteria are met and to verify patient identity and inclusion status. The week of gestation when the patient is included in the study as well as the week of gestation at delivery is recorded.

The type of delivery (vaginal or caesarean section as well as planned or acute) will also be recorded.. General haemostatic parameters are to be analyzed before start of treatment and then every day during treatment and thereafter at least twice a week. Special haemostatic parameters are Placental growth factor, S-Flt-1, VEGF and Syndecan-1. They will be sampled before start of treatment and during treatment once a week. The samples will be collected and frozen and not analyzed before the termination of the study.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gothenburg, Sweden, 41685
        • Dept Obstetrics, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Consisting of treatment with Atenativ
During two weeks antithrombin concentrate(Atenativ) will be administered in order to maintain normal levels of antithrombin
intravenous transfusion
Other Names:
  • antithrombin concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood flow in uterin and umbilical artery
Time Frame: up to day 14
up to day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetal outcome
Time Frame: at birth
CTG, blood flow, Apgar score, birthweight
at birth
bleeding complications
Time Frame: during pregnancy and at delivery
measurements of bleeding before and after placenta delivery
during pregnancy and at delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of endothelial damage
Time Frame: up to day 14
S-Flt-1, VEGF,Syndecan-1
up to day 14
Atenativ concentrate
Time Frame: treatment during 2 weeks
amount needed to maintain normal antithrombin levels
treatment during 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Margareta Hellgren, MD,PhD,prof, department Obstetrics, Sahlgrenska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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