Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00271960
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2005-12-30
Brief Title:
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HIVSTD 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 HIVSTD 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
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 HIVSTD 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 HIVSTD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH061175 | NIH | None | httpsreporternihgovquickSearchR01MH061175 |