Contact information
Type
Scientific
Primary contact
Prof Ekkehard Schleussner
ORCID ID
Contact details
Department of Obstetrics
Friedrich Schiller University
Bachstr. 18
Jena
D-07740
Germany
ekkehard.schleussner@med.uni-jena.de
Additional identifiers
EudraCT number
2006-001984-53
ClinicalTrials.gov number
Protocol/serial number
EudraCT-No.: 2006-001984-53
Study information
Scientific title
Acronym
ETHIGII
Study hypothesis
This study aims at analysing if the rate of pregnancy losses before the 24th week of gestation can be reduced by dalteparin (low molecular heparin) treatment.
Ethics approval
Ethics Commission of the Friedrich Schiller University Jena, Faculty of Medicine (Ethikkommission der Friedrich-Schiller-Universität Jena, Medizinischen Fakultät), approval received on October, 26th, 2006 (reference number: 1837-08/06).
Study design
Open-label, randomised, two-armed, parallel-group, multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pregnant women with a history of recurrent pregnancy loss
Intervention
Patients will be randomised between:
1. Dalteparin 5000 IE daily and multivitamin two tablets daily
2. Multivitamin two tablets daily
Treatment duration: up to the 24th week of gestation
Intervention type
Supplement
Phase
Not Specified
Drug names
Dalteparin and multivitamin
Primary outcome measure
Ongoing intact pregnancy at 24 weeks of gestation
Secondary outcome measures
1. Live birth
2. Late pregnancy complication, defined as at least one of the following:
a. preterm delivery (before 37 weeks of gestation)
b. placenta insufficiency
c. intrauterine growth restriction less than fifth percentile
d. preeclampsia
e. abruptio placentae
3. Foetus with structural anomalies
4. Symptomatic thromboembolic events
5. Side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage)
Overall trial start date
13/11/2006
Overall trial end date
13/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Single pregnancy, fifth to eighth week of gestation
2. Documented foetal heart activity in UltraSound (US)
3. History of recurrent pregnancy loss, defined as:
a. two or more early (less than 12 weeks of gestation) pregnancy losses, or
b. one or more late (more than 12 weeks of gestation) pregnancy loss
4. Aged more than 18 years
5. Written informed consent of the patient
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
486
Participant exclusion criteria
1. Previous pregnancy losses caused by foetal structural or chromosomal anomalies
2. Uterine anomalies
3. Maternal infection, which caused previous pregnancy loss
4. Risk group II or III according to EThIG study (Effectiveness of Thromboseprophylaxe as intervention in the Gravidität) risk stratification (clinical need for heparin prophylaxis)
5. Acute thromboembolic event (need of heparin therapy)
6. Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin
7. Anti-phospholipid antibody syndrome
8. Diabetes mellitus
9. Ongoing nicotine or drug or alcohol abuse
10. Human Immunodeficiency Virus (HIV) positive
11. Expected low compliance (e.g. by travel distance to trial site)
12. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
Recruitment start date
13/11/2006
Recruitment end date
13/01/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Obstetrics
Jena
D-07740
Germany
Sponsor information
Organisation
Friedrich Schiller University Jena (Friedrich-Schiller-Universität Jena) (Germany)
Sponsor details
Bachstr. 18
Jena
D-07740
Germany
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
The study will be funded by Pfizer Pharma GmbH, Karlsruhe (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The baseline medication (Femibion 800 Folsäure Plus Metafolin) will be supplied by Merck Pharma GmbH, Darmstadt (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list