Success rates for consent and collection of prenatal biological specimens in an epidemiologic survey of child health

Abstract

Background The National Children’s Study (NCS) Vanguard Study began enrollment in January 2009 as an initial pilot study for a planned large-scale, longitudinal U.S. cohort study of the effect of environmental influences on child health and development, with biological and environmental sample collection conducted in seven locations from April 2009 to October 2010. We sought to determine rates of consent for, and success of collection of, maternal and paternal biospecimens before and during pregnancy in the NCS Vanguard Study. Methods Samples of blood, saliva, vaginal swabs, urine, hair, and nails were collected prior to and during pregnancy. All specimens were sent to a central repository for processing, storage, and quality assessment. Results Of 780 pregnant women asked to consent to sample collection, 773 (>99%) agreed, and of 295 non-pregnant women, 292 (99%) agreed. Of 440 fathers asked to consent to sample collection, 435 (99%) agreed. Frequency of successful collection of biospecimens varied depending on sample and visit type. In descending order, the ranges over all visit types of the proportion of expected samples successfully collected from women were: urine, 92.5-95.7%; hair, 89.6-92.5%; vaginal swab, 84.2-88.5%; blood, 74.9-78.5%; two-day saliva, 65.8-81.6%; and nails, 76.4-76.7%. For fathers, rates were highest for urine (94.9%) and lowest for hair (63.0%). Conclusions High rates of consent for and collection of a wide variety of biospecimens can be achieved in prospective epidemiologic cohort studies of pregnant women. Ease of sample collection may be a primary factor influencing successful biospecimen collection.

Feasibility of mail-based biospecimen collection in an online preconception cohort study

“…It is unclear which variety of factors motivate individuals to contribute biospecimens for research. Time associated with sample collection has been noted by other researchers to be a burden to successful collection of samples ( 22 ). Rates of consent within our mail-based protocol suggest that the reduced participant burden of collecting samples within one's home without needing to visit a clinic is a key motivator for providing biospecimen samples.…”

Assessment of Exposure to VOCs among Pregnant Women in the National Children’s Study

“…As described elsewhere [ 18 , 23 , 24 ], 1399 women were enrolled in the NCS initial Vanguard Study from 2009 to 2010 from seven locations: Queens County, New York; Duplin County, North Carolina; Salt Lake County, Utah; Orange County, California; Montgomery County, Pennsylvania; Waukesha County, Wisconsin; and four adjacent counties in South Dakota and Minnesota (Brookings County, SD; Yellow Medicine County, MN; Pipestone County, MN; Lincoln County, MN) [ 14 ]. Enrolled women could have completed at least one of several different types of study visits during the NCS initial Vanguard Study: pre-pregnancy visit (P1), first trimester visit (T1), third trimester visit among women who had a prior study visit (T3-Prior), and third trimester visit among women who did not have a prior study visit (T3-First).…”

Characteristics of Environmental influences on Child Health Outcomes (ECHO) Cohorts Recruited During Pregnancy

“…In preparatory work for the National Children's Study, however, results demonstrated that various types of biological sample collections were acceptable to pregnant women considering participation in longitudinal research (Kerver et al, 2013). Biological sampling has been shown to be feasible and acceptable, although the extent, invasiveness, and time required for sample collection are related to successful completion of sampling (Abdul-Rahman et al, 2016). Additionally, research has shown the importance of collecting data from both parents (Younes et al, 2018).…”