Purpose: This study is testing a new counseling program called Counselling for Alcohol Problems in Pregnancy or CAP-Pre, designed to help pregnant women in South Africa to reduce their alcohol use and improve their well-being. Alcohol use during pregnancy can harm babies, leading to Fetal Alcohol Spectrum Disorders (FASD), which can cause lifelong health and developmental problems. Currently, there are no community-based support programs to help pregnant women struggling with alcohol use. What Happens in the Study? 40 pregnant women will take part in the study and will be randomly assigned to one of two groups: 1. CAP-Pre + Standard Health Advice - Women will receive five counseling sessions to help them reduce drinking, plus usual pregnancy care. 2. Standard Health Advice Only - Women will receive usual pregnancy care and an information booklet on alcohol use in pregnancy. The study will test: The study will evaluate if CAP-Pre is easy to deliver, acceptable, and helps women to drink less. (measured by self-report and a blood test). Why Is This Important? South Africa has the highest rates of FASD in the world, but most pregnant women do not receive specialized support for harmful alcohol use. If this pilot study is successful, it will help prepare for a more extensive study to test whether CAP-Pre can be widely used in antenatal care programs. Who Is Involved? The study is run by researchers from Germany and South Africa, with funding from the German Alliance for Global Health Research.
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Self-Reported Alcohol Consumption assessed using the Alcohol Timeline Follow Back (TLFB)
Timeframe: Changes from Baseline to Post Intervention in 6 weeks