Clinical trial NCT01904669: Internet-based Study of Fertility and Early Pregnancy (PEEPS)
Official title: Prospective Evaluation of the Elements of Pregnancy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility
Infertility
Pregnancy
Abortion, Spontaneous
Keywords: Fertility
Infertility
Pregnancy
Conception
Behavioral
Lifestyle
Preconception Care
Women's Health
Abortion, Spontaneous
Cohort Studies
Epidemiology
Internet
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-07-22
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are looking for women ages 18-44 who are planning a pregnancy and have been trying to conceive for \<3 months. Women must have reliable daily access to the Internet. The woman and her male partner may not have any known fertility problems.

Brief summary: The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.

Detailed description: 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. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal 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.

Eligibility criteria: Inclusion Criteria:

* Women
* Ages 18-44
* In a stable relationship
* Sexually active with a male partner
* Reliable daily access to the Internet

Exclusion Criteria:

* Woman or her partner has a known fertility problem
* Trying to conceive for three or more months.

Primary outcomes:
measure: Number enrolled
timeFrame: One year
Secondary outcomes:
measure: Completeness of data collection
timeFrame: Following 9-21 months of data collection
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Medicine
state: Ohio
Study officials:
References: