Pregnancy Clinical Trial
— HIPOfficial title:
Prevention for Prenatal Health: the Health in Pregnancy (HIP) Study
Pregnancy is a critical time to address preventable behavioral risks that pose serious threats to the health of both the mother and the developing fetus. We propose to conduct a randomized, controlled trial to determine the extent to which the Health in Pregnancy (HIP) program, a brief motivational intervention featuring a "Video Doctor," provider cueing sheets, and patient educational worksheets, can reduce pregnant women's cigarette smoking, alcohol drinking, illicit drug use, and domestic violence risks compared with usual care.
Status | Completed |
Enrollment | 410 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 or older - English speaking - Pregnant and receiving prenatal care at a participating study site. Exclusion Criteria: - >25 weeks gestation at baseline session. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Highland Hospital | Oakland | California |
United States | San Francisco General Hospital | San Francisco | California |
United States | St. Luke's Hospital | San Francisco | California |
United States | UCSF Faculty Obstetrics and Gynecology Group | San Francisco | California |
United States | Santa Clara Valley Medical Center | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Elimination of cigarette smoking, alcohol drinking, and illicit drug use. | |||
Primary | Reduction in frequency and/or severity of domestic violence. | |||
Secondary | Patient-provider discussions of risks. | |||
Secondary | Measures of change in cigarette smoking, alcohol drinking, and illicit drug use. |
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