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A RCT of CenteringPregnancy on Birth Outcomes (CRADLE)

Primary Purpose

Pregnancy, Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CenteringPregnancy
Sponsored by
Clemson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Racial disparities

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA
  • Georgia State University
  • Clemson University
  • Prisma Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CenteringPregnancy group prenatal care

Traditional individual prenatal care

Arm Description

Pregnant women who were randomized to receive CenteringPregnancy group prenatal care

Pregnant women who were randomized to receive traditional individual prenatal care

Outcomes

Primary Outcome Measures

Preterm birth
Delivery before 37 weeks gestation

Secondary Outcome Measures

Birth weight
Infant weight (in grams) a birth
APGAR score
Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration
Gestational weight gain
Weight gained during pregnancy as compared to medical recommendation
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)
Gestational hypertension
Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart
Patient activation measure
Based on self-reported questionnaire

Full Information

First Posted
December 20, 2015
Last Updated
August 24, 2022
Sponsor
Clemson University
Collaborators
Prisma Health-Upstate, University of California, Los Angeles, Georgia State University
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1. Study Identification

Unique Protocol Identification Number
NCT02640638
Brief Title
A RCT of CenteringPregnancy on Birth Outcomes
Acronym
CRADLE
Official Title
Reducing Disparities in Birth Outcomes: a Randomized Controlled Trial of CenteringPregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clemson University
Collaborators
Prisma Health-Upstate, University of California, Los Angeles, Georgia State University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Preterm Birth
Keywords
Racial disparities

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CenteringPregnancy group prenatal care
Arm Type
Experimental
Arm Description
Pregnant women who were randomized to receive CenteringPregnancy group prenatal care
Arm Title
Traditional individual prenatal care
Arm Type
No Intervention
Arm Description
Pregnant women who were randomized to receive traditional individual prenatal care
Intervention Type
Behavioral
Intervention Name(s)
CenteringPregnancy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preterm birth
Description
Delivery before 37 weeks gestation
Time Frame
Measured at delivery
Secondary Outcome Measure Information:
Title
Birth weight
Description
Infant weight (in grams) a birth
Time Frame
Measured at delivery
Title
APGAR score
Description
Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration
Time Frame
Measured at delivery
Title
Gestational weight gain
Description
Weight gained during pregnancy as compared to medical recommendation
Time Frame
Measured at delivery
Title
Gestational diabetes incidence
Description
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)
Time Frame
Measured during pregnancy
Title
Gestational hypertension
Description
Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart
Time Frame
Measured during pregnancy
Title
Patient activation measure
Description
Based on self-reported questionnaire
Time Frame
Measured at <20 week and 32-36 week of gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Current incarceration Severe psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moonseong Heo, PhD
Organizational Affiliation
Clemson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Clemson University
City
Clemson
State/Province
South Carolina
ZIP/Postal Code
29634-0745
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31236826
Citation
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.
Results Reference
derived
PubMed Identifier
28403832
Citation
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.
Results Reference
derived

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A RCT of CenteringPregnancy on Birth Outcomes

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