Effectiveness of dalteparin therapy as intervention in recurrent pregnancy loss

ISRCTN	ISRCTN53717039
DOI	https://doi.org/10.1186/ISRCTN53717039
EudraCT/CTIS number	2006-001984-53
Secondary identifying numbers	EudraCT-No.: 2006-001984-53

Submission date: 13/11/2006
Registration date: 03/01/2007
Last edited: 21/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ekkehard Schleussner
Scientific

Department of Obstetrics
Friedrich Schiller University
Bachstr. 18
Jena
D-07740
Germany

Email	ekkehard.schleussner@med.uni-jena.de

Study information

Study design	Open-label, randomised, two-armed, parallel-group, multi-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Effectiveness of dalteparin therapy as intervention in recurrent pregnancy loss
Study acronym	ETHIGII
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
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 study start date	13/11/2006
Completion date	13/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	486
Total final enrolment	449
Key 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
Key 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
Date of first enrolment	13/11/2006
Date of final enrolment	13/01/2011

Locations

Countries of recruitment

Germany

Study participating centre

Department of Obstetrics

Jena
D-07740
Germany

Sponsor information

Friedrich Schiller University Jena (Friedrich-Schiller-Universität Jena) (Germany)
University/education

Bachstr. 18
Jena
D-07740
Germany

Website	http://www.uni-jena.de/Homepage-lang-en.html
"ROR"	https://ror.org/05qpz1x62

Funders

Funder type

Industry

The study will be funded by Pfizer Pharma GmbH, Karlsruhe (Germany)

No information available

The baseline medication (Femibion 800 Folsäure Plus Metafolin) will be supplied by Merck Pharma GmbH, Darmstadt (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			21/04/2020	No	No

Editorial Notes

21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.