The Maternal Lifestyle Study (MLS) (NCT00059540) | Clinical Trial Compass
CompletedNot Applicable
The Maternal Lifestyle Study (MLS)
United States11,811 participantsStarted 1993-05
Plain-language summary
This is a longitudinal, multi-site observational study of the long-term effects of a mother's use of cocaine and/or opiates during pregnancy on her infant. This observational study evaluates the medical, developmental, social, environmental, and neurobehavioral outcomes for 1,400 of the original cohort of children. A series of follow-up examinations of these children were conducted in 5 phases: 1-36 months, 3.5-7 years, and 8-11 years. Children are currently being examined at 13 years of age.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Mothers:
* 18 years or older
* Live near a study site
Exclusion Criteria for Mothers:
* Identified psychosis or history of institutionalization for retardation or emotional problems
* Language barriers that prevented her from giving informed consent or understanding the study
Inclusion Criteria for Infants:
* Inborn infants
* Birthweight \>501 grams (1.1 lbs)
Exclusion Criteria for Infants:
* One of a multiple gestation
* Gestational age \>42 weeks
* Viability of the infant
Questions worth asking your doctor
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.