Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 30, 2005
January 20, 2014
April 2001
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Sexually transmitted disease
  • Rapid repeat pregnancy
  • Sexual risk behavior
  • Perinatal outcomes (e.g., birth weight, gestational age)
Complete list of historical versions of study NCT00271960 on ClinicalTrials.gov Archive Site
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 ]
Psychosocial factors (e.g., depression, stress, social support)
Not Provided
Not Provided
 
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sexually Transmitted Diseases
  • HIV Infections
  • 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.
  • Behavioral: Usual care
    Participants will receive usual prenatal care.
  • Active Comparator: Individual Care
    Participants will receive usual care for their prenatal visits
    Intervention: Behavioral: Usual care
  • Active Comparator: CenteringPregnancy
    Participants will receive CenteringPregnancy(R) group prenatal care
    Intervention: Behavioral: CenteringPregnancy
  • Experimental: CenteringPregnancyPlus
    Participants will receive CenteringPregancy with an HIV/STD prevention component
    Interventions:
    • Behavioral: CenteringPregnancy
    • Behavioral: CenteringPregnancyPlus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1047
December 2008
December 2008   (final data collection date for primary outcome measure)

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)
Female
14 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00271960
R01 MH61175, R01MH061175
No
Jeannette Ickovics, Yale University
Yale University
National Institute of Mental Health (NIMH)
Principal Investigator: Jeannette R. Ickovics, PhD Yale University School of Public Health
Yale University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP