Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Summary
This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.
Description
Millions of young adults become infected with sexually transmitted diseases (STDs) each year. Young adults are particularly vulnerable to STD infection because most are not educated about STDs and use condoms improperly or inconsistently. Transmission of STDs from a pregnant woman to her baby can occur before, during, or after birth. It is, therefore, particularly important to educate young pregnant women about STDs.
Group prenatal care may be a beneficial way to assist young women. It would allow increased contact with care providers, integrate the complex needs of pregnant women, and provide support services. This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV and other STDs in young women during and after pregnancy.
Participants in this unblinded study will be randomly assigned to one of three groups: standard individual prenatal care; standard CenteringPregnancy group prenatal care; or CenteringPregnancy Plus (CP+) group prenatal care. All participants assigned to either CenteringPregnancy or CP+ will have an initial individual medical exam. Groups will be formed based on participants' estimated delivery months, and will be led by a trained independent practitioner. There will be ten 2-hour group sessions between Weeks 16 and 40 of pregnancy. At each session, participants will first weigh themselves and take their blood pressure to chart their own progress. Individual prenatal assessments lasting approximately 30 minutes will be conducted by the practitioner. Participants will then have time to fill out handouts and self-assessments and engage in discussion with other group members. Discussions will focus on education and building prenatal, childbirth, and parenting skills. The CP+ sessions will include an HIV/STD risk reduction component in addition to all the elements of the standard CenteringPregnancy program. This additional feature will consist of interactive discussion, exercises, and skill-building activities targeted towards reducing HIV/STD risk behaviors. Participants assigned to receive standard individual prenatal care will not participate in group sessions, but will receive standard prenatal care. Outcome measures will include incidence of STD infection, rapid repeat pregnancy, degree of sexual risk behavior, perinatal and psychosocial factors.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Sexually Transmitted Diseases
Intervention
CenteringPregnancy, CenteringPregnancyPlus, Usual care
Location
Yale New Haven Hospital, Women's Center
New Haven
Connecticut
United States
06520
Status
Active, not recruiting
Source
National Institute of Mental Health (NIMH)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00271960
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sexually Transmitted Diseases, Viral
Viral diseases which are transmitted or propagated by sexual conduct.
Sexually Transmitted Diseases, Bacterial
Bacterial diseases transmitted or propagated by sexual conduct.
Sexually Transmitted Diseases
Diseases due to or propagated by sexual contact.
Safe Sex
Sexual behavior that prevents or reduces the spread of SEXUALLY TRANSMITTED DISEASES or PREGNANCY.
Unsafe Sex
Sexual behaviors which are high-risk for contracting SEXUALLY TRANSMITTED DISEASES or for producing PREGNANCY.
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