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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01904669
First Posted: July 22, 2013
Last Update Posted: October 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Courtney D.Lynch, PhD MPH, The Ohio State University
  Purpose
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.

Condition
Fertility Infertility Pregnancy Abortion, Spontaneous

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Elements of Pregnancy Study

Further study details as provided by Courtney D.Lynch, PhD MPH, The Ohio State University:

Primary Outcome Measures:
  • Number enrolled [ Time Frame: One year ]

Secondary Outcome Measures:
  • 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 (%).


Enrollment: 161
Study Start Date: July 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904669


Locations
United States, Ohio
The Ohio State University College of Medicine
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Courtney D.Lynch, PhD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Responsible Party: Courtney D.Lynch, PhD MPH, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01904669     History of Changes
Other Study ID Numbers: 2012H0128
1R03HD073504-01 ( U.S. NIH Grant/Contract )
First Submitted: July 15, 2013
First Posted: July 22, 2013
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Courtney D.Lynch, PhD MPH, The Ohio State University:
Fertility
Infertility
Pregnancy
Conception
Behavioral
Lifestyle
Preconception Care
Women's Health
Abortion, Spontaneous
Cohort Studies
Epidemiology
Internet

Additional relevant MeSH terms:
Infertility
Abortion, Spontaneous
Genital Diseases, Male
Genital Diseases, Female
Pregnancy Complications