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Completed

NCT Number: NCT01904669

Internet-based Study of Fertility and Early Pregnancy (PEEPS)

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number enrolled

    Time frame: One year

Secondary outcomes

  1. Completeness of data collection

    Time frame: Following 9-21 months of data collection

    Percentage of the study that the participant completed: baseline questionnaire (Y/N); daily trying to conceive journals (%); weekly pregnancy journals (%); and delivery information (%).

Sponsors and collaborators

Lead sponsor

Courtney D.Lynch, PhD MPH

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Prospective Evaluation of the Elements of Pregnancy Study

Acronym: PEEPS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2013
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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