SAFER pregnancy studie
- Conditions
- Smoking and alcohol use during pregnancy
- Registration Number
- NL-OMON29169
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 66
In order to be eligible to participate in this study, women must meet all of the following criteria:
-Pregnant or having a wish to become pregnant within six months;
-Smoking at least 1 cigarette a day and/or drinking three units of alcohol a week;
-Resident of the municipality of Zoetermeer or Benthuizen.
A potential subject who meets any of the following criteria will be excluded from participation in this study if:
-less than 18 years of age;
-more than 20 weeks pregnant;
-inadequate mastery of the Dutch language;
-refuses the urinary test and/or breath test (when reporting smoking) or blood test (when reporting drinking alcohol);
-the urinary cotinine level is below 50 ug/L, the carbon monoxide (CO) level is less than 7 ppm (when reporting smoking) or the PEth test (when reporting drinking alcohol) is below 7 ug/L at inclusion;
-use of hard drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemically validated cessation of smoking and/or alcohol use at:<br>-Week 34 to 38 of gestation (if they were pregnant at inclusion or became pregnant during the period with sessions); or<br>-The end of the project period if <34 weeks pregnant at the time; or<br>-On the last measurement after six group sessions in those who did not become pregnant during the period with sessions.
- Secondary Outcome Measures
Name Time Method - Barriers and facilitators of implementation (process measures)<br>- Perceived efficiency and appreciation of the eHealth platform, the group sessions, and incentives<br>- Costs<br>- Pregnancy outcomes<br>- Identity changes