There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period. We will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant. Women will submit all data online using StudyTRAX, an electronic data capture tool. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with diary use over time. We will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment. The data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.

Public Health Relevance

There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period. Should the project prove successful, this innovative approach to conducting these types of studies will offer investigators a more efficient and cost-effective method of moving the science forward in this area at a more rapid rate.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Research Grants (R03)
Project #
1R03HD073504-01
Application #
8359833
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
King, Rosalind B
Project Start
2012-08-10
Project End
2014-07-31
Budget Start
2012-08-10
Budget End
2013-07-31
Support Year
1
Fiscal Year
2012
Total Cost
$81,418
Indirect Cost
$28,029
Name
Ohio State University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210