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PROSPECTIVE PREGNANCY STUDY DESIGNS FOR ASSESSING REPRODUCTIVE AND DEVELOPMENTAL TOXICANTS
Citation:
Buck, G. M., C. D. Johnson, J C. Rockett, L. Schieve, S. Schrader, S G. Selevan, J. Stanford, AND A. Sweeney. PROSPECTIVE PREGNANCY STUDY DESIGNS FOR ASSESSING REPRODUCTIVE AND DEVELOPMENTAL TOXICANTS. ENVIRONMENTAL HEALTH PERSPECTIVES 112(1):79-86, (2004).
Description:
Prospective Pregnancy Study Designs for Assessing Reproductive and Developmental Toxicants
Germaine M. Buck,1 Courtney D. Johnson,1 Joseph Stanford,2 Anne Sweeney,3 Laura Schieve,4 John Rockett,5 Sherry G. Selevan,6 Steve Schrader 7
Abstract
The origin of successful human reproduction and development may occur before, at or shortly after conception, underscoring the need to capture exposures during these critical windows when assessing potential reproductive and developmental toxicants. To identify such toxicants, couples of reproductive age, without regard to their ability to ascertain a clinically recognized pregnancy, should be studied.
We addressed the utility and feasibility of prospective pregnancy study designs by conducting a systematic review of the literature to summarize relevant information regarding the planning, implementation, and success of previously published prospective pregnancy studies. Information concerning design elements and participation was abstracted from 15 eligible studies (from a total of 20 identified studies) using a standardized form. The primary author of each study was successfully contacted to review our summary of their work and obtain missing information.
Our findings confirm that researchers are able to recruit women/couples from diverse populations using a variety of recruitment strategies. Among the studies we reviewed, 4-97% of eligible individuals were successfully contacted for study, with enrollment rates ranging from 42-100%. Length of follow-up varied from 3 to 12 months. A high percentage of women provided urine (57-98%) and blood (86-91%) specimens and most male partners (94-100%) provided semen samples.
Our review provides empirical evidence that despite intensive protocols, women/couples can be successfully recruited and retained to participate in prospective pregnancy studies that initiate enrollment prior to pregnancy. These findings underscore the feasibility and utility of prospective pregnancy study designs for assessing toxicants that compromise human reproduction and development.