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PregnancyCRADLENCT02640638

A RCT of CenteringPregnancy on Birth Outcomes

A study testing CenteringPregnancy in people with Pregnancy and Preterm Birth, run by Clemson University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 45 years, women only
Conditions the study is for
Pregnancy, Preterm Birth
What is being tested?
CenteringPregnancy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,350 participants
Where
4 sitesUnited States
Study dates
24 Feb 2016to 21 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Georgia State University

    Atlanta, Georgia, 30303

  • Clemson University

    Clemson, South Carolina, 29634-0745

  • Prisma Health

    Greenville, South Carolina, 29605

  • UCLA

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
CenteringPregnancy
Keywords
Racial disparities
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CenteringPregnancyBehavioural

    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.

Study groups in NCT02640638
Study groupRoleWhat they receive
CenteringPregnancy group prenatal careExperimentalPregnant women who were randomized to receive CenteringPregnancy group prenatal care
Receives: Behavioral: CenteringPregnancy
Traditional individual prenatal careNo interventionPregnant women who were randomized to receive traditional individual prenatal care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preterm birth

    Delivery before 37 weeks gestation

    Measured: Measured at delivery

Secondary outcomes (6)

  1. Birth weight

    Infant weight (in grams) a birth

    Measured: Measured at delivery

  2. APGAR score

    Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration

    Measured: Measured at delivery

  3. Gestational weight gain

    Weight gained during pregnancy as compared to medical recommendation

    Measured: Measured at delivery

  4. 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)

    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)

    Measured: Measured during pregnancy

  5. Gestational hypertension

    Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart

    Measured: Measured during pregnancy

  6. Patient activation measure

    Based on self-reported questionnaire

    Measured: Measured at <20 week and 32-36 week of gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study start24 Feb 2016
  3. Primary completion14 Oct 2020
  4. Study completion21 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02640638
Sponsor's protocol ID
R01HD082311
Acronym
CRADLE
Status last verified
Aug 2022
First submitted
20 Dec 2015
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41947416

  • 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.

    PubMed 40813652

  • 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.

    PubMed 39419550

  • 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.

    PubMed 37917614

  • 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.

    PubMed 37875178

  • 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.

    PubMed 37642966

  • 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.

    PubMed 31236826

  • 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.

    PubMed 28403832

Questions about this trial

What is this clinical trial studying?

A study testing CenteringPregnancy in people with Pregnancy and Preterm Birth, run by Clemson University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preterm birth (time frame: Measured at delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02640638, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.

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