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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeannette Ickovics, Yale University
ClinicalTrials.gov Identifier:
NCT00271960
First received: December 30, 2005
Last updated: January 20, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Completion Date: December 2008
Primary Completion Date: December 2008 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271960

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
Sponsors and Collaborators
Yale University
Investigators
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: January 20, 2014
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 September 16, 2014