Grantee Research Project Results

2006 Progress Report: Study of Phthalates in Pregnant Woman and Children

EPA Grant Number: R829436
Title: Study of Phthalates in Pregnant Woman and Children
Investigators: Swan, Shanna Helen , Lasley, Bill L. , Sparks, Amy , Calafat, Antonia , Redmon, Bruce , Wang, Christina , Kruse, Robin
Institution: University of Rochester , University of Iowa , University of Missouri - Columbia , University of California Los Angeles Medical Center , University of Minnesota , Centers for Disease Control and Prevention , University of California - Davis
Current Institution: University of Rochester , Centers for Disease Control and Prevention , Harbor-UCLA Medical Center , University of California - Davis , University of Iowa , University of Minnesota , University of Missouri - Columbia
EPA Project Officer: Aja, Hayley
Project Period: August 1, 2001 through January 31, 2005 (Extended to July 31, 2007)
Project Period Covered by this Report: August 1, 2005 through July 31,2006
Project Amount: $2,779,164
RFA: Endocrine Disruptors: Epidemiologic Approaches (2001) RFA Text |  Recipients Lists
Research Category: Endocrine Disruptors , Environmental Justice , Human Health , Safer Chemicals

Objective:

To assess the risks posed by environmental phthalate levels to reproductive health.

In particular, we have the following specific aims:

1. Does in utero phthalate exposure alter breast and genital development?
2. How do infants’ pre- and post-natal sensitivity to phthalates compare?
3. What are major sources of phthalate exposure for pregnant women and infants?
4. Do phthalate metabolite levels vary with ethnicity and geography?
5. Do genital and breast measurements vary with ethnicity and geography?
6. How is phthalate metabolism altered by pregnancy?

Approach:

The Study for Future Families (SFF), currently being conducted by this research team in four U.S. cities, has enrolled close to 300 pregnant women and their partners. SFF mothers who agree to participate, and their children, will constitute population for the current study; we expect to study 800 mothers and children. Pediatric physicians will conduct two standardized breast and genital examinations on each child. We will identify 100 children in whom one or more breast and genital measurements are atypical. These children, plus those with definite or probable genital anomalies, will be selected for phthalate analyses together with an equal number of children matched on sex, gestational age, study center and ethnicity, for whom all measurements fall within the central 90% of the distribution. We will measure phthalate metabolite levels during and after pregnancy in the mothers, and in these 200 children during the first year of life. Phthalate metabolite levels will be examined in relation to examination outcomes, including genital size, amount of breast tissue and FSH level. We will also seek to identify sources of phthalate exposure by relating mothers' self-reported use of phthalate-containing products (soaps, cosmetics, teething rings, nipples and other plastics) at the time of urine collection to measured phthalate metabolite levels.

Progress Summary:

By December 1, 2006, we had:

• Completed data collection at all four centers (CA, MN, MO, and IA). In total we recruited 455 mothers and their babies and conducted a total of 642 baby exams (455 first visit exams and 187 second visit exams).
• Collected 608 baby urine samples (438 at first study visit and 169 at second visit).
• Collected 619 maternal (postnatal) urine samples (447 at first study visit and 172 at second study visit).
• Created final, cleaned SAS data sets for all mother’s questionnaires and baby exams.
• Obtained phthalate metabolite data on a total of 804 urine samples (mother’s prenatal, postnatal, and baby urine samples).
• Conducted analyses of boys’ genital parameters measured during 234 exams (166 boys of whom 66 had two exams).
• Conducted analyses of genital parameters on the 106 of these boys whose mothers had prenatal phthalate measurements and prepared manuscript on these results.
• Conducted analysis of baby phthalate concentration in relation to baby-product use (N = 163) and submitted manuscript on these results to Pediatrics (with Pediatric Environmental Fellow Sheela Sathyanarayana, University of Washington).
• Conducted analyses of prenatal DEHP exposure, gestational age and birth weight (with doctoral student Jennifer Adiibi, Harvard School of Public Health)
• Identified and shipped 765 urine samples (103 men’s, 103 women’s prenatal, 19 women’s postnatal and 177 babies’ samples) to be analyzed by the Centers for Disease Control and Prevention (CDC) in the final study year.

Expected Results:

If positive associations are identified, they can be used to estimate reproductive risk of specific phthalates. If no positive associations are found, these data will provide moderate assurance that routine use of phthalate-containing products poses no reproductive risks to infants. These results will also identify home and personal care products associated with elevated phthalate levels in women of reproductive age and their offspring.

Future Activities:

During Year 3 we expect to (see Table 1):

• Complete recruitment of all Study for Future Families II (SFFII) babies (total 50 expected).
• Complete all baby exams (50 first visits and 109 second visits expected).
• Complete collection of urine samples (159 maternal, 159 baby samples expected).

Table 1.

	As of 10/1/04	Expected YR 3	Total
Number of Mothers	409	50	459
Number of Babies Recruited	416	50	466
Number of Baby Exams 1st Visit	413	50	463
Number of Baby Exams 2nd Visit	135	109	244
Number of Mother Urine Samples (both visits)	538	159	697
Number of Baby Urine Samples (both visits)	519	159	678

• Phthalate analyses on first 350 babies, prenatal maternal urines and postnatal maternal urines. (We will request an extension in time only in which remaining samples will be analyzed).
• Conduct analysis of product use and phthalate levels in first 300 mothers and children. (We will request an extension in time only in which statistical analysis of remaining samples will be analyzed).
• Conduct analysis of baby exams and prenatal and baby levels in first 300 mothers and children. (We will request an extension in time only in which statistical analysis of remaining samples will be analyzed).

Journal Articles:

No journal articles submitted with this report: View all 41 publications for this project

Supplemental Keywords:

phthalates, prenatal exposure, sexual development, geography, ethnicity,, Health, RFA, Scientific Discipline, Susceptibility/Sensitive Population/Genetic Susceptibility, Health Risk Assessment, Risk Assessments, Chemistry, genetic susceptability, Epidemiology, Endocrine Disruptors - Human Health, endocrine disruptors, Biochemistry, Endocrine Disruptors - Environmental Exposure & Risk, infants, pregnancy, developmental biology, human growth and development, prenatal exposure, exposure studies, pregnant women, endocrine disrupting chemicals, children, developmental effects, endocrine disruption, exposure, epidemiologic studies, metabolites, sexual development, reproductive health, childhood development

Relevant Websites:

http://fcm.missouri.edu/Research/Default.aspx Exit

Progress and Final Reports:

Original Abstract

2002 Progress Report

2003 Progress Report

2004

2005 Progress Report

Final Report