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

NCT ID: NCT01904669

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Fertility Infertility Pregnancy Abortion, Spontaneous

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Courtney D.Lynch, PhD MPH

OTHER

Sponsor Role lead

Responsible Party

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Courtney D.Lynch, PhD MPH

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Ohio State University College of Medicine

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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1R03HD073504-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012H0128

Identifier Type: -

Identifier Source: org_study_id

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