Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexually Transmitted Diseases HIV Infections |
Behavioral: CenteringPregnancy Behavioral: CenteringPregnancyPlus Behavioral: Usual care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women |
- Sexually transmitted disease [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
- Rapid repeat pregnancy [ Time Frame: Measured at Month 12 postpartum ] [ Designated as safety issue: No ]
- Sexual risk behavior [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
- Perinatal outcomes (e.g., birth weight, gestational age) [ Time Frame: Measured at Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
- Psychosocial factors (e.g., depression, stress, social support) [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
| Enrollment: | 1047 |
| Study Start Date: | April 2001 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Individual Care
Participants will receive usual care for their prenatal visits
|
Behavioral: Usual care
Participants will receive usual prenatal care.
|
|
Active Comparator: CenteringPregnancy
Participants will receive CenteringPregnancy(R) group prenatal care
|
Behavioral: CenteringPregnancy
Following the initial intake into obstetric care in the usual manner, participants will be invited to join with 8 to 12 other women/couples/teens with similar due dates, meeting together regularly during their pregnancy.
|
|
Experimental: CenteringPregnancyPlus
Participants will receive CenteringPregancy with an HIV/STD prevention component
|
Behavioral: CenteringPregnancy
Following the initial intake into obstetric care in the usual manner, participants will be invited to join with 8 to 12 other women/couples/teens with similar due dates, meeting together regularly during their pregnancy.
Behavioral: CenteringPregnancyPlus
CenteringPregnancyPlus is a modified program that integrated HIV/STD prevention components with the group prenatal care model. Participants will learn skill-building in the areas of efficacy, risk assessment, negotiation skills and prevention.
|
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.
Eligibility| Ages Eligible for Study: | 14 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any severe medical problems requiring individualized assessment and tracking as a "high-risk pregnancy" (e.g., active substance use, mental illness, HIV)
Contacts and Locations| United States, Connecticut | |
| Yale New Haven Hospital, Women's Center | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Georgia | |
| Grady Memorial Hospital | |
| Atlanta, Georgia, United States, 30350 | |
| Principal Investigator: | Jeannette R. Ickovics, PhD | Yale University School of Public Health |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeannette Ickovics, Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00271960 History of Changes |
| Other Study ID Numbers: | R01 MH61175, R01MH061175 |
| Study First Received: | December 30, 2005 |
| Last Updated: | August 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
Pregnancy Birth Weight Gestational Age Preterm Delivery HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Infection Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013