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AzTrials

Sexually Transmitted DiseasesPhase 3NCT00271960

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

A Phase 3 study testing CenteringPregnancy and CenteringPregnancyPlus in people with Sexually Transmitted Diseases and HIV Infections, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sexually Transmitted Diseases, HIV Infections
What is being tested?
CenteringPregnancy and CenteringPregnancyPlus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,047 participants
Where
2 sitesUnited States
Study dates
Apr 2001to Dec 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • Any severe medical problems requiring individualized assessment and tracking as a "high-risk pregnancy" (e.g., active substance use, mental illness, HIV)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Grady Memorial Hospital

    Atlanta, Georgia, 30350

  • Yale New Haven Hospital, Women's Center

    New Haven, Connecticut, 06520

Other trials in United States

About this study

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.

Read the 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.

Being tested
CenteringPregnancy, CenteringPregnancyPlus, Usual care
Keywords
Pregnancy, Birth Weight, Gestational Age, Preterm Delivery, HIV Seronegativity
Medical subject headings
Sexually Transmitted Diseases, HIV Infections, Birth Weight, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CenteringPregnancyBehavioural

    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.

  • CenteringPregnancyPlusBehavioural

    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.

  • Usual careBehavioural

    Participants will receive usual prenatal care.

Study groups in NCT00271960
Study groupRoleWhat they receive
Individual CareActive comparatorParticipants will receive usual care for their prenatal visits
Receives: Behavioral: Usual care
CenteringPregnancyActive comparatorParticipants will receive CenteringPregnancy(R) group prenatal care
Receives: Behavioral: CenteringPregnancy
CenteringPregnancyPlusExperimentalParticipants will receive CenteringPregancy with an HIV/STD prevention component
Receives: Behavioral: CenteringPregnancy; Behavioral: CenteringPregnancyPlus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sexually transmitted disease

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

  2. Rapid repeat pregnancy

    Measured: Measured at Month 12 postpartum

  3. Sexual risk behavior

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

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

    Measured: Measured at Months 6 and 12 postpartum

Secondary outcomes (1)

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2006 (estimated)
  2. Study startApr 2001
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,047 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00271960
Sponsor's protocol ID
0008011972
Other IDs
R01MH061175
Status last verified
Apr 2020
First submitted
30 Dec 2005
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17964637

  • 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.

    PubMed 16620257

  • 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.

    PubMed 19762662

  • 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.

    PubMed 17666608

  • 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.

    PubMed 21318932

  • 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.

    PubMed 20974459

  • 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.

    PubMed 23059493

  • 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.

    PubMed 19085680

  • 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.

    PubMed 24562504

  • 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.

    PubMed 24447189

  • 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.

    PubMed 23524175

  • 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.

    PubMed 18166312

  • 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.

    PubMed 17845525

  • 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.

    PubMed 17601908

  • 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.

    PubMed 16865541

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CenteringPregnancy and CenteringPregnancyPlus in people with Sexually Transmitted Diseases and HIV Infections, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexually transmitted disease (time frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00271960, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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