MedTrace Logo

PROTECT Pregnancy Study: An Exploratory Study of Self-reported Medication Use in Pregnant Women

NCT02924077 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2521

Last updated 2016-10-05

No results posted yet for this study

Summary

Study was a non-interventional, prospective study of pregnant women who agreed to provide information about their medication use and certain lifestyle factors on a periodic basis throughout their pregnancy. Volunteers were recruited by measures such as placement of pamphlets near pregnancy test kits in pharmacies and by links from carefully selected websites and social networking sites. Subjects were invited to learn about the study either through visiting the study web site or phoning a telephone number where a recorded message described the study and invite eligible women to register for participation.

Participants were asked whether they prefer to provide data via the internet or by interactive voice response system (IVRS).

Data were collected in the predominant natural languages of the four study countries: Denmark, the Netherlands, Poland, and the United Kingdom (UK).

Data were collected on use of prescription and non-prescription medication, as well as on use of herbals and homeopathic medications. More information was be collected from women who provided their response over the internet than by phone, in order to best utilize the full capacity of internet- based data collection.

Conditions

  • Pregnancy

Sponsors & Collaborators

  • Quintiles, Inc.

    lead INDUSTRY

Principal Investigators

  • Nancy Dreyer, MPH, PhD · Quintiles Real-World & Late Phase Reasearch, Cambridge, USA

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02924077 on ClinicalTrials.gov