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

IMI PROTECT - Work Package 4 - Pregnancy Study: An Exploratory Study of Self-reported Medication Use in Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy

Detailed Description

The PROTECT Pregnancy Study was designed to pilot direct-to-patient data collection methods for use in postmarketing surveillance into the foetal effects of maternal medication use in pregnancy. This study which recruited women between October 2012 and January 2014 explored whether women in participating EU countries were willing to provide information via the internet to enable prospective collection of medication exposure data and information about other life style factors during pregnancy. The study's main objective was to assess the extent to which data collected directly from pregnant women via the Internet and an interactive voice response system (IVRS) would provide information on medication use and other potential risk factors throughout pregnancy that is suitable for research purposes.

Pregnant women were recruited for the study using a variety of methods and were asked about use of medications, alcohol and tobacco, recreational drugs, herbals and other factors that could negatively affect birth outcome. The pilot study revealed that women would indeed volunteer to provide information on medication and lifestyle factors during pregnancy, with 2521 women enrolling from four countries over 8-18 months. The four countries include the United Kingdom (UK), The Netherlands (NL), Denmark (DK) and Poland (PL). Of those who enrolled in the PROTECT pregnancy study, only 2066 provided any data, with all but one providing data via internet.

• Study Type: Observational
• Enrollment (Actual): 2521

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Quintiles, Inc.
• Investigators: Study Director: Nancy Dreyer, MPH, PhD, Quintiles Real-World & Late Phase Reasearch, Cambridge, USA

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PROTECT_WP4_v8Mar12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO