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Systematic Reviews
Published in: Systematic Reviews 1/2014

Open Access 01-12-2014 | Protocol

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

Authors: Marc A Rodger, Nicole J Langlois, Johanna IP de Vries, Évelyne Rey, Jean-Christophe Gris, Ida Martinelli, Ekkehard Schleussner, Timothy Ramsay, Ranjeeta Mallick, Becky Skidmore, Saskia Middeldorp, Shannon Bates, David Petroff, Dick Bezemer, Marion E van Hoorn, Carolien NH Abheiden, Annalisa Perna, Paulien de Jong, Risto Kaaja

Published in: Systematic Reviews | Issue 1/2014

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Abstract

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, A n individual patient data meta-analysis oF low-molecular-weight heparin F or prevention of placenta-medI ated pR egnancy 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
Appendix
Available only for authorised users
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Metadata
Title
Low-molecular-weight heparin for prevention of placenta-mediated pregnancy complications: protocol for a systematic review and individual patient data meta-analysis (AFFIRM)
Authors
Marc A Rodger
Nicole J Langlois
Johanna IP de Vries
Évelyne Rey
Jean-Christophe Gris
Ida Martinelli
Ekkehard Schleussner
Timothy Ramsay
Ranjeeta Mallick
Becky Skidmore
Saskia Middeldorp
Shannon Bates
David Petroff
Dick Bezemer
Marion E van Hoorn
Carolien NH Abheiden
Annalisa Perna
Paulien de Jong
Risto Kaaja
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2014
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/2046-4053-3-69

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