Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

NCT00400387 | Completed Phase 3

• 1 other identifier: EudraCT 2006-001984-53
• Study Type: interventional
• Target: 449
• Locations: 2 countries
• Sites: 12

Brief Summary

With this clinical trial the investigators will analyze whether the rate of pregnancy losses before the 24th week of gestation can be reduced by dalteparin treatment in habitual aborters.

Conditions

Abortion, Habitual

Keywords

recurrent pregnancy loss

Outcome Measures

Primary Outcomes (1)

• ongoing intact pregnancy at 24 weeks of gestation

  at 24 weeks of gestation

Secondary Outcomes (5)

• late pregnancy complication, defined as at least one of the following: preterm delivery, placenta insufficiency, intrauterine growth retardation, preeclampsia and abruptio placentae

  6-8 weeks after delivery

• foetus with structural anomalies

  6-8 weeks after delivery

• side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage)

  6-8 weeks after delivery

• life birth

  6-8 weeks after delivery

• preterm delivery (< 37 weeks of gestation)

  6-8 weeks after delivery

Study Arms (2)

Multivitamin supplement

OTHER

Dietary Supplement: Multivitamin supplement

Multivitamin supplement + dalteparin sodium

EXPERIMENTAL

Drug: Fragmin P Forte (dalteparin sodium)

Interventions

Fragmin P Forte (dalteparin sodium) DRUG

subcutaneous injection, once daily supported by multivitamine supplement and close monitoring

Also known as: low molecular weight heparin

Multivitamin supplement + dalteparin sodium

Multivitamin supplement DIETARY_SUPPLEMENT

general pregnancy support by multivitamin supplementation and close monitoring

Also known as: Femibion 800 Folsäure plus Metafolin:, Ascorbinsäure 110 mg, Nicotinamid 15 mg, alpha-Tocopherol acetat 13 mg, RRR-alpha-Tocopherol Äquivalent 7.93 mg, Pantothensäure 6 mg, Pyridoxin 1.9 mg, Riboflavin 1.6 mg, Thiamin 1.2 mg, olsäure 0.4 mg, Biotin 0.06 mg, Cyanocobalamin 0.0035 mg, Calcium mefolinat, Folsäure 0.4 mg, Kalium iodid, Iodid Ion 0.15 mg

Multivitamin supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single pregnancy, 5th to 8th week of gestation
• Documented foetal heart activity in US
• History of recurrent pregnancy loss, defined as:
• or more early (\< 12 weeks of gestation) pregnancy losses or
• or more late (\> 12 weeks of gestation) pregnancy loss
• at least 18 years of age
• Written informed consent of the patient

You may not qualify if:

• Previous pregnancy losses caused by foetal structural or chromosomal anomalies
• Uterine anomalies
• Maternal infection which caused previous pregnancy loss
• Risk group II or III according to ETHIG I risk stratification (clinical need for heparin prophylaxis)
• Acute thromboembolic event (need of heparin therapy)
• Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin)
• Antiphospholipid antibody syndrome
• Diabetes mellitus
• Ongoing nicotine or drug or alcohol abuse
• Known HIV infection
• Expected low compliance (e.g. by travel distance to trial site)
• Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial

Sponsors & Collaborators

• University of Jena: lead

Study Sites (12)

Kinderwunschinstitut Schenk

Dobl, A-8143, Austria

Location

Martin-Luther-Universität Halle Wittenberg

Halle, Saxony-Anhalt, 06120, Germany

Location

Universitätsfrauenklinik am Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

Halle, 06110, Germany

Location

Medizinische Hochschule Hannover, Abt. für Gynäkologie und Geburtshilfe

Hanover, 30625, Germany

Location

Frauenklinik Landshut Achdorf

Landshut, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Klinikum der Universität München Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

München, 81377, Germany

Location

Frauenklinik der Technischen Universität München, Klinikum rechts der Isa

München, 81675, Germany

Location

Praxis für medizinische Genetik

Regensburg, 93047, Germany

Location

Klinikum Stuttgart, Frauenklinik

Stuttgart, 70374, Germany

Location

Universitätsfrauenklinik Tübingen

Tübingen, 72076, Germany

Location

Related Publications (3)

• Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.

  PMID: 33779986 DERIVED

• Rogenhofer N, Markoff A, Wagner A, Klein HG, Petroff D, Schleussner E; EThIG II Group; Thaler CJ. Lessons From the EThIGII Trial: Proper Putative Benefit Assessment of Low-Molecular-Weight Heparin Treatment in M2/ANXA5 Haplotype Carriers. Clin Appl Thromb Hemost. 2017 Jan;23(1):27-33. doi: 10.1177/1076029616658117. Epub 2016 Jul 14.

  PMID: 27418639 DERIVED

• Schleussner E, Kamin G, Seliger G, Rogenhofer N, Ebner S, Toth B, Schenk M, Henes M, Bohlmann MK, Fischer T, Brosteanu O, Bauersachs R, Petroff D; ETHIG II group. Low-molecular-weight heparin for women with unexplained recurrent pregnancy loss: a multicenter trial with a minimization randomization scheme. Ann Intern Med. 2015 May 5;162(9):601-9. doi: 10.7326/M14-2062.

  PMID: 25938990 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Dalteparin; Heparin, Low-Molecular-Weight; levomefolate calcium; Ascorbic Acid; Pyridoxine; Riboflavin; Thiamine; Biotin; Vitamin B 12; Leucovorin

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Thiazoles; Sulfur Compounds; Azoles; Pyrimidines; Imidazoles; Corrinoids; Tetrapyrroles; Pyrroles; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins

Study Officials

• Ekkehard Schleussner, Prof. Dr.

  University of Jena, Hospital for gynaecology and obstetrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 16, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

DE (11); AU (1)