Dokumentenart: | Artikel | ||||
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Titel eines Journals oder einer Zeitschrift: | Annals of Internal Medicine | ||||
Verlag: | AMER COLL PHYSICIANS | ||||
Ort der Veröffentlichung: | PHILADELPHIA | ||||
Band: | 162 | ||||
Nummer des Zeitschriftenheftes oder des Kapitels: | 9 | ||||
Seitenbereich: | S. 601-609 | ||||
Datum: | 2015 | ||||
Institutionen: | Medizin > Lehrstuhl für Humangenetik | ||||
Identifikationsnummer: |
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Stichwörter / Keywords: | INHERITED THROMBOPHILIA; VENOUS THROMBOEMBOLISM; GENETIC THROMBOPHILIA; MISCARRIAGE; COMPLICATIONS; THROMBOPROPHYLAXIS; PROPORTIONS; LIPOPROTEIN; ENOXAPARIN; ASPIRIN; | ||||
Dewey-Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin | ||||
Status: | Veröffentlicht | ||||
Begutachtet: | Ja, diese Version wurde begutachtet | ||||
An der Universität Regensburg entstanden: | Ja | ||||
Dokumenten-ID: | 60435 |
Zusammenfassung
Background: A daily injection of low-molecular-weight heparin (LMWH) is often prescribed to women with unexplained recurrent pregnancy loss (RPL), although evidence suggesting a benefit is questionable. Objective: To determine whether LMWH increases ongoing pregnancy and live-birth rates in women with unexplained RPL. Design: Controlled, multicenter trial with randomization using minimization ...
Zusammenfassung
Background: A daily injection of low-molecular-weight heparin (LMWH) is often prescribed to women with unexplained recurrent pregnancy loss (RPL), although evidence suggesting a benefit is questionable. Objective: To determine whether LMWH increases ongoing pregnancy and live-birth rates in women with unexplained RPL. Design: Controlled, multicenter trial with randomization using minimization conducted from 2006 to 2013. (ClinicalTrials.gov: NCT00400387) Setting: 14 university hospitals and perinatal care centers in Germany and Austria. Patients: 449 women with at least 2 consecutive early miscarriages or 1 late miscarriage were included during 5 to 8 weeks' gestation after a viable pregnancy was confirmed by ultrasonography. Intervention: Women in the control group received multivitamin pills, and the intervention group received vitamins and 5000 IU of dalteparin-sodium for up to 24 weeks' gestation. Measurements: Primary outcome was ongoing pregnancy at 24 weeks' gestation. Secondary outcomes included the live-birth rate and late pregnancy complications. Results: At 24 weeks' gestation, 191 of 220 pregnancies (86.8%) and 188 of 214 pregnancies (87.9%) were intact in the interven-tion and control groups, respectively (absolute difference, -1.1 percentage points [95% CI, -7.4 to 5.3 percentage points]). The live-birth rates were 86.0% (185 of 215 women) and 86.7% (183 of 211 women) in the intervention and control groups, respectively (absolute difference, -0.7 percentage point [CI, -7.3 to 5.9 percentage points]). There were 3 intrauterine fetal deaths (1 woman had used LMWH); 9 cases of preeclampsia or the hemolysis, elevated liver enzyme level, and low platelet count (HELLP) syndrome (3 women had used LMWH); and 11 cases of intrauterine growth restriction or placental insufficiency (5 women had used LMWH). Limitation: Placebo injections were not used, and neither trial staff nor patients were blinded. Conclusion: Daily LMWH injections do not increase ongoing pregnancy or live-birth rates in women with unexplained RPL. Given the burden of the injections, they are not recommended for preventing miscarriage.
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