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

October 26, 2015 updated by: Courtney D.Lynch, PhD MPH

Prospective Evaluation of the Elements of Pregnancy Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women who are trying to conceive
Women ages 18-44 without a history of fertility problems who are in a stable relationship with a male partner who have regular access to the Internet and have been trying to conceive <3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number enrolled
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%).
Following 9-21 months of data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Courtney D.Lynch, PhD MPH

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012H0128
  • 1R03HD073504-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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