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      The effect of low-molecular-weight heparin on live birth rate of patients with unexplained early recurrent pregnancy loss: A two-arm randomized clinical trial

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          Abstract

          Background:

          The effect of anticoagulant medication in unexplained early recurrent pregnancy loss (RPL) patients is controversial. This clinical trial evaluated the effect of low-molecular-weight heparin (LMWH) on pregnancy outcomes in these patients.

          Materials and Methods:

          The study was performed as a single-blind randomized clinical trial between 2016 and 2018. Samples were selected from patients who were referred to Avicenna RPL clinic with a history of at least two previously happened early unexplained miscarriages. The eligibility was defined strictly to select unexplained RPL patients homogenously. One hundred and seventy-three patients who got pregnant recently were allocated randomly into two groups LMWH plus low-dose aspirin treatment (Group A = 85) and low-dose aspirin treatment only (Group B = 88)) and were followed up till their pregnancy termination (delivery/abortion). A per-protocol analysis was carried out and all statistical tests were two-sided with a P < 0.05 significance level.

          Results:

          The live birth rates (LBRs) in Groups A and B were 78% and 77.1%, respectively, which did not show any statistically significant difference between the two groups, neither in rates nor in time of abortion. In subgroup analysis for polycystic ovary syndrome (PCOS) patients, the odds ratio for study outcome (intervention/control) was 2.25 (95% confidence interval: 0.65–7.73). There was no major adverse event whereas minor bleeding was observed in 18% of patients in Group A.

          Conclusion:

          LMWH does not improve the LBR in unexplained RPL patients, however, it is recommended to evaluate its effect separately in PCOS patients.

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          Most cited references33

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          Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome

          (2004)
          Article 0 comments Cited 749 times – based on 0 reviews     Review now
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            ESHRE guideline: recurrent pregnancy loss

            Ruth Bender Atik, Ole Christiansen, Janine Elson … (2018)
            Abstract STUDY QUESTION What is the recommended management of women with recurrent pregnancy loss (RPL) based on the best available evidence in the literature? SUMMARY ANSWER The guideline development group formulated 77 recommendations answering 18 key questions on investigations and treatments for RPL, and on how care should be organized. WHAT IS KNOWN ALREADY A previous guideline for the investigation and medical treatment of recurrent miscarriage was published in 2006 and is in need of an update. STUDY DESIGN, SIZE, DURATION The guideline was developed according to the structured methodology for development of ESHRE guidelines. After formulation of key questions by a group of experts, literature searches and assessments were performed. Papers published up to 31 March 2017 and written in English were included. Cumulative live birth rate, live birth rate and pregnancy loss rate (or miscarriage rate) were considered the critical outcomes. PARTICIPANTS/MATERIALS, SETTING, METHODS Based on the collected evidence, recommendations were formulated and discussed until consensus was reached within the guideline group. A stakeholder review was organized after finalization of the draft. The final version was approved by the guideline group and the ESHRE Executive Committee. MAIN RESULTS AND THE ROLE OF CHANCE The guideline provides 38 recommendations on risk factors, prevention and investigations in couples with RPL, and 39 recommendations on treatments. These include 60 evidence-based recommendations – of which 31 were formulated as strong recommendations and 29 as conditional – and 17 good practice points. The evidence supporting investigations and treatment of couples with RPL is limited and of moderate quality. Of the evidence-based recommendations, only 10 (16.3%) were supported by moderate quality evidence. The remaining recommendations were supported by low (35 recommendations: 57.4%), or very low quality evidence (16 recommendations: 26.2%). There were no recommendations based on high quality evidence. Owing to the lack of evidence-based investigations and treatments in RPL care, the guideline also clearly mentions investigations and treatments that should not be used for couples with RPL. LIMITATIONS, REASONS FOR CAUTION Several investigations and treatments are offered to couples with RPL, but most of them are not well studied. For most of these investigations and treatments, a recommendation against the intervention or treatment was formulated based on insufficient evidence. Future studies may require these recommendations to be revised. WIDER IMPLICATIONS OF THE FINDINGS The guideline provides clinicians with clear advice on best practice in RPL, based on the best evidence available. In addition, a list of research recommendations is provided to stimulate further studies in RPL. One of the most important consequences of the limited evidence is the absence of evidence for a definition of RPL. STUDY FUNDING/COMPETING INTEREST(S) The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the dissemination of the guideline. The guideline group members did not receive payment. J.E. reports position funding from CARE Fertility. S.L. reports position funding from SpermComet Ltd. S.M. reports research grants, consulting and speaker’s fees from GSK, BMS/Pfizer, Sanquin, Aspen, Bayer and Daiichi Sankyo. S.Q. reports speaker’s fees from Ferring. The other authors report no conflicts of interest. ESHRE Pages are not externally peer reviewed. This article has been approved by the Executive Committee of ESHRE.
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              Evaluation and treatment of recurrent pregnancy loss: a committee opinion.

              (2012)
              The majority of miscarriages are sporadic and most result from genetic causes that are greatly influenced by maternal age. Recurrent pregnancy loss (RPL) is defined by two or more failed clinical pregnancies, and up to 50% of cases of RPL will not have a clearly defined etiology. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Res Med Sci
                Journal ID (iso-abbrev): J Res Med Sci
                Journal ID (publisher-id): JRMS
                Title: Journal of Research in Medical Sciences : The Official Journal of Isfahan University of Medical Sciences
                Publisher: Wolters Kluwer - Medknow (India )
                ISSN (Print): 1735-1995
                ISSN (Electronic): 1735-7136
                Publication date Collection: 2022
                Publication date (Electronic): 31 October 2022
                Volume: 27
                Electronic Location Identifier: 78
                Affiliations
                [1 ]Reproductive Biotechnology Research Center, ACECR, Avicenna Research Institute, Tehran, Iran
                [2 ]Avicenna Fertility Center, Tehran, Iran
                [3 ]Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran
                [4 ]Department of Reproductive Health and Midwifery, Tarbiat Modares University, Tehran, Iran
                Author notes
                Address for correspondence: Prof. Soheila Ansaripour, Avicenna Research Institute, Evin, Daneshjoo Blvd, Chamran Exp.Way, Tehran 1936773493, Iran. E-mail: soh.ansaripour@ 123456gmail.com
                [†]

                A.Mohammad-Akbari and A.Mohazzab are equally first authors

                Article
                Publisher ID: JRMS-27-78
                DOI: 10.4103/jrms.jrms_81_21
                PMC ID: 9693726
                PubMed ID: 36438075
                SO-VID: ec62beb5-5f57-4c48-bd8b-ac709cccc2af
                Copyright © Copyright: © 2022 Journal of Research in Medical Sciences
                License:

                This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

                History
                Date received : 26 January 2021
                Date revision received : 26 February 2022
                Date accepted : 30 May 2022
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Medicine
                Keywords: live birth rate,low-molecular-weight heparin,recurrent early pregnancy loss
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: live birth rate, low-molecular-weight heparin, recurrent early pregnancy loss

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