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

Primary Purpose

Sexually Transmitted Diseases, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CenteringPregnancy
CenteringPregnancyPlus
Usual care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Pregnancy, Birth Weight, Gestational Age, Preterm Delivery, HIV Seronegativity

Eligibility Criteria

14 Years - 25 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Yale New Haven Hospital, Women's Center
  • Grady Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Individual Care

CenteringPregnancy

CenteringPregnancyPlus

Arm Description

Participants will receive usual care for their prenatal visits

Participants will receive CenteringPregnancy(R) group prenatal care

Participants will receive CenteringPregancy with an HIV/STD prevention component

Outcomes

Primary Outcome Measures

Sexually transmitted disease
Rapid repeat pregnancy
Sexual risk behavior
Perinatal outcomes (e.g., birth weight, gestational age)

Secondary Outcome Measures

Psychosocial factors (e.g., depression, stress, social support)

Full Information

First Posted
December 30, 2005
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00271960
Brief Title
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Official Title
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, HIV Infections
Keywords
Pregnancy, Birth Weight, Gestational Age, Preterm Delivery, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1047 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Care
Arm Type
Active Comparator
Arm Description
Participants will receive usual care for their prenatal visits
Arm Title
CenteringPregnancy
Arm Type
Active Comparator
Arm Description
Participants will receive CenteringPregnancy(R) group prenatal care
Arm Title
CenteringPregnancyPlus
Arm Type
Experimental
Arm Description
Participants will receive CenteringPregancy with an HIV/STD prevention component
Intervention Type
Behavioral
Intervention Name(s)
CenteringPregnancy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CenteringPregnancyPlus
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Participants will receive usual prenatal care.
Primary Outcome Measure Information:
Title
Sexually transmitted disease
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Rapid repeat pregnancy
Time Frame
Measured at Month 12 postpartum
Title
Sexual risk behavior
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Perinatal outcomes (e.g., birth weight, gestational age)
Time Frame
Measured at Months 6 and 12 postpartum
Secondary Outcome Measure Information:
Title
Psychosocial factors (e.g., depression, stress, social support)
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette R. Ickovics, PhD
Organizational Affiliation
Yale University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital, Women's Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30350
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17964637
Citation
Ickovics JR. "Bundling" HIV prevention: integrating services to promote synergistic gain. Prev Med. 2008 Mar;46(3):222-5. doi: 10.1016/j.ypmed.2007.09.006. Epub 2007 Sep 29.
Results Reference
background
PubMed Identifier
16620257
Citation
Massey Z, Rising SS, Ickovics J. CenteringPregnancy group prenatal care: Promoting relationship-centered care. J Obstet Gynecol Neonatal Nurs. 2006 Mar-Apr;35(2):286-94. doi: 10.1111/j.1552-6909.2006.00040.x.
Results Reference
background
PubMed Identifier
19762662
Citation
Kershaw TS, Magriples U, Westdahl C, Rising SS, Ickovics J. Pregnancy as a window of opportunity for HIV prevention: effects of an HIV intervention delivered within prenatal care. Am J Public Health. 2009 Nov;99(11):2079-86. doi: 10.2105/AJPH.2008.154476. Epub 2009 Sep 17.
Results Reference
result
PubMed Identifier
17666608
Citation
Ickovics JR, Kershaw TS, Westdahl C, Magriples U, Massey Z, Reynolds H, Rising SS. Group prenatal care and perinatal outcomes: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):330-9. doi: 10.1097/01.AOG.0000275284.24298.23. Erratum In: Obstet Gynecol. 2007 Oct;110(4):937.
Results Reference
result
PubMed Identifier
21318932
Citation
Ickovics JR, Reed E, Magriples U, Westdahl C, Schindler Rising S, Kershaw TS. Effects of group prenatal care on psychosocial risk in pregnancy: results from a randomised controlled trial. Psychol Health. 2011 Feb;26(2):235-50. doi: 10.1080/08870446.2011.531577.
Results Reference
result
PubMed Identifier
20974459
Citation
Gould Rothberg BE, Magriples U, Kershaw TS, Rising SS, Ickovics JR. Gestational weight gain and subsequent postpartum weight loss among young, low-income, ethnic minority women. Am J Obstet Gynecol. 2011 Jan;204(1):52.e1-11. doi: 10.1016/j.ajog.2010.08.028. Epub 2010 Oct 25.
Results Reference
result
PubMed Identifier
23059493
Citation
Magriples U, Boynton MH, Kershaw TS, Duffany KO, Rising SS, Ickovics JR. Blood pressure changes during pregnancy: impact of race, body mass index, and weight gain. Am J Perinatol. 2013 May;30(5):415-24. doi: 10.1055/s-0032-1326987. Epub 2012 Oct 11. Erratum In: Am J Perinatol. 2013 Feb;30(2):161. Duffany, Kathleen O [added].
Results Reference
result
PubMed Identifier
19085680
Citation
Magriples U, Kershaw TS, Rising SS, Westdahl C, Ickovics JR. The effects of obesity and weight gain in young women on obstetric outcomes. Am J Perinatol. 2009 May;26(5):365-71. doi: 10.1055/s-0028-1110088. Epub 2008 Dec 11.
Results Reference
result
PubMed Identifier
24562504
Citation
Agrawal A, Ickovics J, Lewis JB, Magriples U, Kershaw TS. Postpartum intimate partner violence and health risks among young mothers in the United States: a prospective study. Matern Child Health J. 2014 Oct;18(8):1985-92. doi: 10.1007/s10995-014-1444-9.
Results Reference
result
PubMed Identifier
24447189
Citation
Cole-Lewis HJ, Kershaw TS, Earnshaw VA, Yonkers KA, Lin H, Ickovics JR. Pregnancy-specific stress, preterm birth, and gestational age among high-risk young women. Health Psychol. 2014 Sep;33(9):1033-45. doi: 10.1037/a0034586. Epub 2014 Jan 20.
Results Reference
result
PubMed Identifier
23524175
Citation
Novick G, Reid AE, Lewis J, Kershaw TS, Rising SS, Ickovics JR. Group prenatal care: model fidelity and outcomes. Am J Obstet Gynecol. 2013 Aug;209(2):112.e1-6. doi: 10.1016/j.ajog.2013.03.026. Epub 2013 Mar 21.
Results Reference
result
PubMed Identifier
18166312
Citation
Magriples U, Kershaw TS, Rising SS, Massey Z, Ickovics JR. Prenatal health care beyond the obstetrics service: utilization and predictors of unscheduled care. Am J Obstet Gynecol. 2008 Jan;198(1):75.e1-7. doi: 10.1016/j.ajog.2007.05.040.
Results Reference
result
PubMed Identifier
17845525
Citation
Kershaw TS, Lewis J, Westdahl C, Wang YF, Rising SS, Massey Z, Ickovics J. Using clinical classification trees to identify individuals at risk of STDs during pregnancy. Perspect Sex Reprod Health. 2007 Sep;39(3):141-8. doi: 10.1363/3914107.
Results Reference
result
PubMed Identifier
17601908
Citation
Westdahl C, Milan S, Magriples U, Kershaw TS, Rising SS, Ickovics JR. Social support and social conflict as predictors of prenatal depression. Obstet Gynecol. 2007 Jul;110(1):134-40. doi: 10.1097/01.AOG.0000265352.61822.1b.
Results Reference
result
PubMed Identifier
16865541
Citation
Kershaw TS, Milan S, Westdahl C, Lewis J, Rising SS, Fletcher R, Ickovics J. Avoidance, anxiety, and sex: the influence of romantic attachment on HIV-risk among pregnant women. AIDS Behav. 2007 Mar;11(2):299-311. doi: 10.1007/s10461-006-9153-z.
Results Reference
result
PubMed Identifier
20976536
Citation
Kershaw TS, Arnold A, Lewis JB, Magriples U, Ickovics JR. The skinny on sexual risk: the effects of BMI on STI incidence and risk. AIDS Behav. 2011 Oct;15(7):1527-38. doi: 10.1007/s10461-010-9842-5.
Results Reference
derived

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

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