A RCT of CenteringPregnancy on Birth Outcomes (CRADLE)

Reducing Disparities in Birth Outcomes: a Randomized Controlled Trial of CenteringPregnancy

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Preterm Birth
• Intervention / Treatment: Behavioral: CenteringPregnancy

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 Type: Interventional
• Enrollment (Actual): 2350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Georgia State University
  • South Carolina
    • Clemson, South Carolina, United States, 29634-0745
      • Clemson University
    • Greenville, South Carolina, United States, 29605
      • Prisma Health

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth	Delivery before 37 weeks gestation	Measured at delivery

Secondary Outcome Measures

Outcome Measure	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	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); hr: 180 mg/dL or 190 mg/dL (10.0/10.6); hr: 155 mg/dL or 165 mg/dL (8.6/9.2); hr: 140 mg/dL or 145 mg/dL (7.8/8.0)	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

Collaborators and Investigators

• Sponsor: Clemson University
• Collaborators: University of California, Los Angeles; Prisma Health-Upstate; Georgia State University
• Investigators: Principal Investigator: Moonseong Heo, PhD, Clemson University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2016
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: December 20, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Racial disparities
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: R01HD082311 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF