Low-molecular-weight heparin for prevention of placenta-mediated pregnancy complications: protocol for a systematic review and individual patient data meta-analysis (AFFIRM)

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dc.contributor.authorRodger, Marc A
dc.contributor.authorLanglois, Nicole J
dc.contributor.authorde Vries, Johanna I
dc.contributor.authorRey, Évelyne
dc.contributor.authorGris, Jean-Christophe
dc.contributor.authorMartinelli, Ida
dc.contributor.authorSchleussner, Ekkehard
dc.contributor.authorRamsay, Timothy
dc.contributor.authorMallick, Ranjeeta
dc.contributor.authorSkidmore, Becky
dc.contributor.authorMiddeldorp, Saskia
dc.contributor.authorBates, Shannon
dc.contributor.authorPetroff, David
dc.contributor.authorBezemer, Dick
dc.contributor.authorvan Hoorn, Marion E
dc.contributor.authorAbheiden, Carolien N
dc.contributor.authorPerna, Annalisa
dc.contributor.authorde Jong, Paulien
dc.contributor.authorKaaja, Risto
dc.date.accessioned2015-12-18T10:59:03Z
dc.date.available2015-12-18T10:59:03Z
dc.date.issued2014-06-26
dc.identifier.citationSystematic Reviews. 2014 Jun 26;3(1):69
dc.identifier.urihttp://dx.doi.org/10.1186/2046-4053-3-69
dc.identifier.urihttp://hdl.handle.net/10393/34030
dc.description.abstractAbstract Background Placenta-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/Design We 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. Discussion 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 specifically prevented by low-molecular-weight heparin. Systematic review registration PROSPERO (International Prospective Registry of Systematic Reviews) 23 December 2013, CRD42013006249
dc.titleLow-molecular-weight heparin for prevention of placenta-mediated pregnancy complications: protocol for a systematic review and individual patient data meta-analysis (AFFIRM)
dc.typeJournal Article
dc.date.updated2015-12-18T10:59:03Z
dc.language.rfc3066en
dc.rights.holderRodger et al.; licensee BioMed Central Ltd.
CollectionLibre accès - Publications // Open Access - Publications

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