| Item type: | Article | ||||
|---|---|---|---|---|---|
| Journal or Publication Title: | Annals of Internal Medicine | ||||
| Publisher: | AMER COLL PHYSICIANS | ||||
| Place of Publication: | PHILADELPHIA | ||||
| Volume: | 162 | ||||
| Number of Issue or Book Chapter: | 9 | ||||
| Page Range: | pp. 601-609 | ||||
| Date: | 2015 | ||||
| Institutions: | Medicine > Lehrstuhl für Humangenetik | ||||
| Identification Number: |
| ||||
| Keywords: | INHERITED THROMBOPHILIA; VENOUS THROMBOEMBOLISM; GENETIC THROMBOPHILIA; MISCARRIAGE; COMPLICATIONS; THROMBOPROPHYLAXIS; PROPORTIONS; LIPOPROTEIN; ENOXAPARIN; ASPIRIN; | ||||
| Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine | ||||
| Status: | Published | ||||
| Refereed: | Yes, this version has been refereed | ||||
| Created at the University of Regensburg: | Yes | ||||
| Item ID: | 60435 |
Web of ScienceAbstract
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 ...
Abstract
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.
Metadata last modified: 19 Dec 2024 07:34
Altmetric