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Clinical Trials/NCT00271960
NCT00271960CompletedPhase 3

Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women

Yale University2 sites in 1 country1,047 target enrollmentStarted: April 1, 2001Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,047
Locations
2
Primary Endpoint
Sexual risk behavior

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
14 Years to 25 Years (Child, Adult)
Sex
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)

Arms & Interventions

Individual Care

Active Comparator

Participants will receive usual care for their prenatal visits

Intervention: Usual care (Behavioral)

CenteringPregnancy

Active Comparator

Participants will receive CenteringPregnancy(R) group prenatal care

Intervention: CenteringPregnancy (Behavioral)

CenteringPregnancyPlus

Experimental

Participants will receive CenteringPregancy with an HIV/STD prevention component

Intervention: CenteringPregnancy (Behavioral)

CenteringPregnancyPlus

Experimental

Participants will receive CenteringPregancy with an HIV/STD prevention component

Intervention: CenteringPregnancyPlus (Behavioral)

Outcomes

Primary Outcomes

Sexual risk behavior

Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

Sexually transmitted disease

Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

Perinatal outcomes (e.g., birth weight, gestational age)

Time Frame: Measured at Months 6 and 12 postpartum

Rapid repeat pregnancy

Time Frame: Measured at Month 12 postpartum

Secondary Outcomes

  • Psychosocial factors (e.g., depression, stress, social support)(Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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