A RCT of CenteringPregnancy on Birth Outcomes (CRADLE)

• ClinicalTrials.gov Identifier: NCT02640638
• Recruitment Status: Completed
• First Posted: December 29, 2015
• Last Update Posted: August 26, 2022
• Sponsor: Clemson University
• Collaborators: Prisma Health-Upstate; University of California, Los Angeles; Georgia State University
• Information provided by (Responsible Party): Moonseong Heo, Clemson University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; Preterm Birth	Behavioral: CenteringPregnancy	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Reducing Disparities in Birth Outcomes: a Randomized Controlled Trial of CenteringPregnancy
• Actual Study Start Date: February 24, 2016
• Actual Primary Completion Date: October 14, 2020
• Actual Study Completion Date: January 21, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: CenteringPregnancy group prenatal care; Pregnant women who were randomized to receive CenteringPregnancy group prenatal care	Behavioral: CenteringPregnancy; 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.
No Intervention: Traditional individual prenatal care; Pregnant women who were randomized to receive traditional individual prenatal care

Outcome Measures

Primary Outcome Measures :

1. Preterm birth [ Time Frame: Measured at delivery ]
   Delivery before 37 weeks gestation

Secondary Outcome Measures :

1. Birth weight [ Time Frame: Measured at delivery ]
   Infant weight (in grams) a birth
2. APGAR score [ Time Frame: Measured at delivery ]
   Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration
3. Gestational weight gain [ Time Frame: Measured at delivery ]
   Weight gained during pregnancy as compared to medical recommendation
4. Gestational diabetes incidence [ Time Frame: Measured during pregnancy ]

   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)

   1. hr: 180 mg/dL or 190 mg/dL (10.0/10.6)
   2. hr: 155 mg/dL or 165 mg/dL (8.6/9.2)
   3. hr: 140 mg/dL or 145 mg/dL (7.8/8.0)
5. Gestational hypertension [ Time Frame: Measured during pregnancy ]
   Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart
6. Patient activation measure [ Time Frame: Measured at <20 week and 32-36 week of gestational age ]
   Based on self-reported questionnaire

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Pregnant women aged between 14-45 years
2. 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.

Exclusion Criteria:

1. 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

2. 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

3. Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care

   • Current incarceration
   • Severe psychiatric illness

Contacts and Locations

Locations

United States, California

UCLA

Los Angeles, California, United States, 90095

United States, Georgia

Georgia State University

Atlanta, Georgia, United States, 30303

United States, South Carolina

Clemson University

Clemson, South Carolina, United States, 29634-0745

Prisma Health

Greenville, South Carolina, United States, 29605

Sponsors and Collaborators

Clemson University

Prisma Health-Upstate

University of California, Los Angeles

Georgia State University

Investigators

• Principal Investigator: Moonseong Heo, PhD; Clemson University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Moonseong Heo, Contact Principal Investigator, Clemson University
• ClinicalTrials.gov Identifier: NCT02640638
• Other Study ID Numbers: R01HD082311 ( U.S. NIH Grant/Contract )
• First Posted: December 29, 2015
• Last Update Posted: August 26, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (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.

Keywords provided by Moonseong Heo, Clemson University:

Racial disparities

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases