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| Name | Class |
|---|---|
| Prisma Health-Upstate | OTHER |
| University of California, Los Angeles | OTHER |
| Georgia State University | OTHER |
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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.
This is a randomized controlled trial to compare biomedical, behavioral and psychosocial outcomes by race among pregnant women who participate in CenteringPregnancy group prenatal care, to women in the traditional individual prenatal care and to investigate whether improving women's stress, activation and engagement will explain the potential benefits of CenteringPregnancy on outcomes and health disparities. The trial will be conducted in a large prenatal care center in South Carolina. Eligible White and Black women will be recruited before 20 weeks of gestational age with low risk pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CenteringPregnancy group prenatal care | Experimental | Pregnant women who were randomized to receive CenteringPregnancy group prenatal care |
|
| Traditional individual prenatal care | No Intervention | Pregnant women who were randomized to receive traditional individual prenatal care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CenteringPregnancy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth | Delivery before 37 weeks gestation | Measured at delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | Infant weight (in grams) a birth | Measured at delivery |
| APGAR score | Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration |
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Inclusion Criteria:
Exclusion Criteria:
Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care
Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care
Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care
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| Name | Affiliation | Role |
|---|---|---|
| Moonseong Heo, PhD | Clemson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Georgia State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41947416 | Derived | Nianogo RA, Hsieh CT, Chen Y, Britt JL, Zhang L, Crockett AH, Chen L. Effect of Group Prenatal Care Attendance on Gestational Diabetes Mellitus and Preterm Birth. Birth. 2026 Apr 7. doi: 10.1111/birt.70070. Online ahead of print. | |
| 40813652 | Derived | Heo M, Britt JL, Zhang L, Doherty EA, Crockett AH. Optimal group and individual prenatal care visit patterns and preterm birth. BMC Pregnancy Childbirth. 2025 Aug 14;25(1):848. doi: 10.1186/s12884-025-07987-1. |
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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.
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.
Requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Measured at delivery |
| Gestational weight gain | Weight gained during pregnancy as compared to medical recommendation | Measured at delivery |
| Gestational diabetes incidence | Diabetes (occurred during pregnancy (two steps: 50-g GLT (nonfasting) with PG measurement at 1 h (Step 1), at 24-28 wks in women not previously diagnosed with overt diabetes If PG at 1 h after load is ≥140 mg/dL (7.8 mmol/L), proceed to 100-g OGTT (Step 2), performed while patient is fasting GDM diagnosis made when two or more PG levels meet or exceed: Fasting: 95 mg/dL or 105 mg/dL (5.3/5.8)
| Measured during pregnancy |
| Gestational hypertension | Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart | Measured during pregnancy |
| Patient activation measure | Based on self-reported questionnaire | Measured at <20 week and 32-36 week of gestational age |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Clemson University | Clemson | South Carolina | 29634-0745 | United States |
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| 39419550 | Derived | 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. |
| 37917614 | Derived | 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. |
| 37875178 | Derived | 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. |
| 37642966 | Derived | 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. |
| 31236826 | Derived | 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. |
| 28403832 | Derived | 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. |
| D000091642 | Urogenital Diseases |