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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Ohio State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Courtney D.Lynch, PhD MPH, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01904669
First received: July 15, 2013
Last updated: March 17, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Number enrolled [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Completeness of data collection [ Time Frame: Following 9-21 months of data collection ] [ Designated as safety issue: No ]
    Percentage of the study that the participant completed: baseline questionnaire (Y/N); daily trying to conceive journals (%); weekly pregnancy journals (%); and delivery information (%).


Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years to 44 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904669

Contacts
Contact: Courtney D Lynch, PhD, MPH 614-366-3899 peeps@osumc.edu

Locations
United States, Ohio
The Ohio State University College of Medicine Recruiting
Columbus, Ohio, United States, 43210
Contact: Courtney D Lynch, PhD, MPH         
Principal Investigator: Courtney D Lynch, PhD, MPH         
Sponsors and Collaborators
Courtney D.Lynch, PhD MPH
  More Information

Additional Information:
No publications provided

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
Study First Received: July 15, 2013
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Fertility
Infertility
Pregnancy
Conception
Behavioral
Lifestyle
Preconception Care
Women's Health
Abortion, Spontaneous
Cohort Studies
Epidemiology
Internet

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

ClinicalTrials.gov processed this record on August 18, 2014