NCT02640638

Brief Summary

The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral outcomes, and decrease the racial difference in selected birth outcomes among African American and White women, compared to individual prenatal care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,350

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

4.6 years

First QC Date

December 20, 2015

Last Update Submit

August 24, 2022

Conditions

PregnancyPreterm Birth

Keywords

Racial disparities

Outcome Measures

Primary Outcomes (1)

  • Preterm birth

    Delivery before 37 weeks gestation

    Measured at delivery

Secondary Outcomes (6)

  • Birth weight

    Measured at delivery

  • APGAR score

    Measured at delivery

  • Gestational weight gain

    Measured at delivery

  • Gestational diabetes incidence

    Measured during pregnancy

  • Gestational hypertension

    Measured during pregnancy

  • +1 more secondary outcomes

Study Arms (2)

CenteringPregnancy group prenatal care

EXPERIMENTAL

Pregnant women who were randomized to receive CenteringPregnancy group prenatal care

Behavioral: CenteringPregnancy

Traditional individual prenatal care

NO INTERVENTION

Pregnant women who were randomized to receive traditional individual prenatal care

Interventions

CenteringPregnancyBEHAVIORAL

8-12 pregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute.

CenteringPregnancy group prenatal care

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women aged between 14-45 years
  • Entry prenatal care before 20 6/7 weeks gestational age (defined as attendance at the intake screening visit). Patients must be randomized by 23 6/7 weeks gestational age.

You may not qualify if:

  • Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care
  • Pregestational diabetes,
  • Severe chronic hypertension requiring medication,
  • Morbid Obesity with BMI \>49.99
  • Renal disease with baseline proteinuria \>1g/24 hours
  • Any disease requiring chronic immunosuppression (SLE, solid organ transplant)
  • Active pulmonary tuberculosis
  • Sickle cell anemia
  • Human Immunodeficiency Virus Infection
  • Other medical conditions that would exclude women from group care at the discretion of the PI
  • Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care
  • Multiple gestation
  • Lethal fetal anomalies
  • Other pregnancy complications that would exclude women from group care at the discretion of the PI
  • Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCLA

Los Angeles, California, 90095, United States

Location

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Clemson University

Clemson, South Carolina, 29634-0745, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (6)

  • Hsieh CT, Zhang L, Britt J, Shodahl S, Crockett A, Chen L. Pregnancy Anxiety and Risk of Gestational Diabetes Mellitus Among a Diverse U.S. Cohort. J Womens Health (Larchmt). 2025 Jan;34(2):206-213. doi: 10.1089/jwh.2024.0453. Epub 2024 Oct 17.

    PMID: 39419550DERIVED

  • Doherty EA, Cartmell K, Griffin S, Heo M, Chen L, Britt JL, Crockett AH. Discrimination and Adverse Perinatal Health Outcomes: A Latent Class Analysis. Prev Chronic Dis. 2023 Nov 2;20:E96. doi: 10.5888/pcd20.230094.

    PMID: 37917614DERIVED

  • Keenan-Devlin L, Miller GE, Ernst LM, Freedman A, Smart B, Britt JL, Singh L, Crockett AH, Borders A. Inflammatory markers in serum and placenta in a randomized controlled trial of group prenatal care. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101200. doi: 10.1016/j.ajogmf.2023.101200. Epub 2023 Oct 22.

    PMID: 37875178DERIVED

  • Chen Y, Crockett AH, Britt JL, Zhang L, Nianogo RA, Qian T, Nan B, Chen L. Group vs Individual Prenatal Care and Gestational Diabetes Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330763. doi: 10.1001/jamanetworkopen.2023.30763.

    PMID: 37642966DERIVED

  • Francis E, Johnstone MB, Convington-Kolb S, Witrick B, Griffin SF, Sun X, Crockett A, Chen L. Group Prenatal Care Attendance and Women's Characteristics Associated with Low Attendance: Results from Centering and Racial Disparities (CRADLE Study). Matern Child Health J. 2019 Oct;23(10):1371-1381. doi: 10.1007/s10995-019-02784-7.

    PMID: 31236826DERIVED

  • Chen L, Crockett AH, Covington-Kolb S, Heberlein E, Zhang L, Sun X. Centering and Racial Disparities (CRADLE study): rationale and design of a randomized controlled trial of centeringpregnancy and birth outcomes. BMC Pregnancy Childbirth. 2017 Apr 13;17(1):118. doi: 10.1186/s12884-017-1295-7.

    PMID: 28403832DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Moonseong Heo, PhD

    Clemson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Contact Principal Investigator

Study Record Dates

First Submitted

December 20, 2015

First Posted

December 29, 2015

Study Start

February 24, 2016

Primary Completion

October 14, 2020

Study Completion

January 21, 2021

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Deidentified study data will be available publicly on the NICHD/DASH Data and Specimen Hub (https://dash.nichd.nih.gov/) in October 2026, five years after study completion. Prior to that time, researchers with a methodologically sound proposal can direct inquiries to amy.crockett@prismahealth.org to gain access to the study protocol, informed consent forms, deidentified data, data dictionaries and the analytic plan. Requestors will need to sign a data access agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Deidentified study data will be available publicly on the NICHD/DASH Data and Specimen Hub (https://dash.nichd.nih.gov/) in October 2026, five years after study completion.
Access Criteria
Requestors will need to sign a data access agreement.

Locations

US(4)