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

NCT02924077 | Completed

• 1 other identifier: PROTECT_WP4_v8Mar12
• Study Type: observational
• Target: 2,521
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pregnancy Outcome

  Patient-reported pregnancy outcome is assessed upon pregnancy termination, stillbirth or live birth, recorded from point of enrollment through 30 days after expected date of confinement. No time to event analyses are performed since the study purpose is to compare self-reported events, including pregnancy outcome, with those same events recorded in electronic medical records and the national pregnancy register in Denmark.

  At pregnancy end (delivery or termination)

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It was initially planned that a minimum of 1400 pregnant women (5600 women total, study-wide) will be recruited from each of the four participating countries: Denmark, the Netherlands, Poland, and the United Kingdom. From this number of 1400 participants per country, a limit of 200 women (800 women total, study-wide) would have contributed data via the phone recording system while 1200 would have participate online.

You may qualify if:

• Women who identify themselves as pregnant;
• Access to the internet or telephone for providing data;
• Willingness to provide either their e-mail address or telephone number for automated follow-up reminders;
• Primary residence in one of the four participating EU countries: Denmark, the Netherlands, Poland, and the United Kingdom;
• Proficiency in the predominant natural language of their country of residence : Danish, Dutch, Polish, or English.

You may not qualify if:

• Women below the age for providing consent.
• Women who are not resident in one of the four participating countries.
• Women in Denmark who are not willing to provide their civil registration number

Sponsors & Collaborators

• Quintiles, Inc.: lead

Study Officials

• Nancy Dreyer, MPH, PhD

  Quintiles Real-World & Late Phase Reasearch, Cambridge, USA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 5, 2016
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share