Abstract
BackgroundPlacenta-mediated pregnancy complications include pre-eclampsia, late pregnancy loss, placental abruption, and the small-for-gestational age newborn. They are leading causes of maternal, fetal, and neonatal morbidity and mortality in developed nations. Women who have experienced these complications are at an elevated risk of recurrence in subsequent pregnancies. However, despite decades of research no effective strategies to prevent recurrence have been identified, until recently. We completed a pooled summary-based meta-analysis that strongly suggests that low-molecular-weight heparin reduces the risk of recurrent placenta-mediated complications. The proposed individual patient data meta-analysis builds on this successful collaboration. The project is called AFFIRM, An individual patient data meta-analysis oF low-molecular-weight heparin For prevention of placenta-medIated pRegnancy coMplications.Methods/DesignWe conducted a systematic review to identify randomized controlled trials with a low-molecular-weight heparin intervention for the prevention of recurrent placenta-mediated pregnancy complications. Investigators and statisticians representing eight trials met to discuss the outcomes and analysis plan for an individual patient data meta-analysis. An additional trial has since been added for a total of nine eligible trials. The primary analyses from the original trials will be replicated for quality assurance prior to recoding the data from each trial and combining it into a common dataset for analysis. Using the anonymized combined data we will conduct logistic regression and subgroup analyses aimed at identifying which women with previous pregnancy complications benefit most from treatment with low-molecular-weight heparin during pregnancy.DiscussionThe goal of the proposed individual patient data meta-analysis is a thorough estimation of treatment effects in patients with prior individual placenta-mediated pregnancy complications and exploration of which complications are specifically prevented by low-molecular-weight heparin.Systematic review registrationPROSPERO (International Prospective Registry of Systematic Reviews) 23 December 2013, CRD42013006249
Highlights
Placenta-mediated pregnancy complications include pre-eclampsia, late pregnancy loss, placental abruption, and the small-for-gestational age newborn
The goal of the proposed individual patient data meta-analysis is a thorough estimation of treatment effects in patients with prior individual placenta-mediated pregnancy complications and exploration of which complications are prevented by low-molecular-weight heparin
Analyzing original data from individual patients makes use of a much richer dataset and has greater statistical power than conventional metaanalysis [31,32]. For this project, individual patient data meta-analysis (IPDMA) will allow for adjustment for covariates that are known to be important in the recurrence of placenta-mediated pregnancy complications
Summary
This IPDMA will permit the investigators to explore which women within the heterogeneous group of patients with placenta-mediated complications benefit and which women do not benefit from low-molecular-weight heparin injections throughout pregnancy. Privacy and security The subjects in each of the RCTs all provided informed consent to participate in the original trial. We will not be seeking individual consent for the secondary use of the data for the following reasons: the objectives of the IPDMA are consistent with the original trials, there are no risks or benefits associated with this analysis, no identifying information will be transferred, and it would be logistically time consuming and, in some cases, impossible to contact the women who participated. In order to ensure patient confidentiality any identifying information will be removed from the original dataset before it is transferred. The IronKeyTM flash drive includes numerous security features including hardware-based encryption, a random password generator, two-factor authentication, and a self-destruct mechanism which make it extremely unlikely that the dataset can be accessed by anyone other than the intended recipient. Once the data are merged in Ottawa in the common database, they will be stored on the research institute’s network which has multiple security features and regular backup procedures in place
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