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

Prospective Evaluation of the Elements of Pregnancy Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01904669

Acronym

PEEPS

Enrollment

161

Registered

2013-07-22

Start date

2013-07-31

Completion date

2015-08-31

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Spontaneous, Fertility, Infertility, Pregnancy

Keywords

Fertility, Infertility, Pregnancy, Conception, Behavioral, Lifestyle, Preconception Care, Women's Health, Abortion, Spontaneous, Cohort Studies, Epidemiology, Internet

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number enrolled	One year

Secondary

Measure	Time frame	Description
Completeness of data collection	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 (%).

Countries

United States

Outcome results