NCT01904669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

July 15, 2013

Last Update Submit

October 26, 2015

Conditions

FertilityInfertilityPregnancyAbortion, Spontaneous

Keywords

FertilityInfertilityPregnancyConceptionBehavioralLifestylePreconception CareWomen's HealthAbortion, SpontaneousCohort StudiesEpidemiologyInternet

Outcome Measures

Primary Outcomes (1)

  • Number enrolled

    One year

Secondary Outcomes (1)

  • Completeness of data collection

    Following 9-21 months of data collection

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Women
  • Ages 18-44
  • In a stable relationship
  • Sexually active with a male partner
  • Reliable daily access to the Internet

You may not qualify if:

  • Woman or her partner has a known fertility problem
  • Trying to conceive for three or more months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

InfertilityAbortion, SpontaneousBehavior

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 22, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

US(1)