Mental and Behavioural Disorders Nervous System Diseases Nutritional, Metabolic, Endocrine Pregnancy and Childbirth Paediatrics
Conditions
Interventions
Placebo
Sponsors
NIH National Institute on Alcohol Abuse and Alcoholism
University of Cape Town Faculty of Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Currently pregnant -Antenatal care initiation by the 23rd week of gestation -Currently reports heavy drinking (at least 1.0 oz absolute alcohol (~2 standard drinks) per day on average; or at least 1 incident of binge drinking (4 or more standard drinks on a single occasion) during pregnancy)
Exclusion criteria
Exclusion criteria: Maternal exclusionary criteria: -age <18 years -HIV infection -multiple gestation pregnancy -pharmacologic treatment for a serious preexisting medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems) -use of methamphetamine -plans to move from the area before study completion Infant exclusionary criteria: -major chromosomal anomalies -neural tube defects -seizures -very low birthweight (<1,500 g) - weeks gestational at delivery <32 weeks (Women were recruited and both male and female infants were included.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant adherence to regimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal plasma choline concentration;Dietary choline intake.;PEMT genotype;Infant weight;Infant length;Infant head circumference;Infant eyeblink conditioning;Infant visual recognition memory on the Fagan Test of Infant Intelligence;Infant information processing speed on the Fagan Test of Infant Intelligence. | — |
Countries
South Africa
Contacts
Public ContactSandra Jacobson
CoPrincipal Investigator
Outcome results
None listed