Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
- Conditions
- Sexually Transmitted DiseasesHIV Infections
- Interventions
- Behavioral: CenteringPregnancyBehavioral: Usual careBehavioral: CenteringPregnancyPlus
- Registration Number
- NCT00271960
- Lead Sponsor
- Yale University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1047
- Pregnant and currently at less than 24 weeks gestation
- English- or Spanish-speaking
- Willing to be randomly assigned to either group or individual prenatal care
- Any severe medical problems requiring individualized assessment and tracking as a "high-risk pregnancy" (e.g., active substance use, mental illness, HIV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CenteringPregnancyPlus CenteringPregnancy Participants will receive CenteringPregancy with an HIV/STD prevention component Individual Care Usual care Participants will receive usual care for their prenatal visits CenteringPregnancyPlus CenteringPregnancyPlus Participants will receive CenteringPregancy with an HIV/STD prevention component CenteringPregnancy CenteringPregnancy Participants will receive CenteringPregnancy(R) group prenatal care
- Primary Outcome Measures
Name Time Method Rapid repeat pregnancy Measured at Month 12 postpartum Sexual risk behavior Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum Sexually transmitted disease Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum Perinatal outcomes (e.g., birth weight, gestational age) Measured at Months 6 and 12 postpartum
- Secondary Outcome Measures
Name Time Method Psychosocial factors (e.g., depression, stress, social support) Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Trial Locations
- Locations (2)
Yale New Haven Hospital, Women's Center
🇺🇸New Haven, Connecticut, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States