A Suggested Approach for Implementing CONSORT Guidelines Specific to Obstetric Research.
ABSTRACT The conduct and reporting of randomized controlled trials (RCTs) are enhanced by being compliant with the CONsolidated Standards of Reporting Trials (CONSORT) statement. The statement was meant to be general and was aimed at most RCTs without any particular focus on specific groups of patients. However, research in pregnancy presents important unique issues and challenges that are not addressed in the CONSORT statement. Thus, we suggest that there is a need to amend the statement to address RCTs enrolling pregnant or postpartum women. We propose CONSORT-OB (OBstetrics), with more than 30 modifications to the current statement. We hope the CONSORT group would consider our proposal, and we respectfully suggest that investigators incorporate these additional data into their reporting of RCTs involving pregnant or postpartum women.
- Obstetrics and Gynecology 10/2013; DOI:10.1097/01.AOG.0000435080.10951.39 · 4.37 Impact Factor
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ABSTRACT: Traditionally, the primary outcome of infertility trials has been a positive pregnancy test or a clinically recognized pregnancy. However, parents desire a healthy baby that grows up to be a healthy adult, rather than a positive pregnancy test. Too often results of infertility trials are lacking in crucial obstetric details. This is problematic because treatments for infertility have the capacity to increase the risk for a variety of adverse obstetric outcomes. This review will outline important obstetric variables that should be included when reporting infertility research. The rationale for including these data, precise definitions of the variables, and cost-effective strategies for obtaining these obstetric details will be highlighted.Fertility and sterility 05/2014; 101(5):1209-1216. DOI:10.1016/j.fertnstert.2014.03.027 · 4.59 Impact Factor