Condition category
Pregnancy and Childbirth
Date applied
13/11/2006
Date assigned
03/01/2007
Last edited
03/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.uni-jena.de/Homepage-lang-en.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes