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OpenTrials
Completed

NCT Number: NCT02640638

A RCT of CenteringPregnancy on Birth Outcomes

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.

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Key information

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCLA, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Preterm birth

    Time frame: Measured at delivery

    Delivery before 37 weeks gestation

Secondary outcomes

  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)

    • 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)
  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

Sponsors and collaborators

Lead sponsor

Clemson University

Other

Collaborators

  • Georgia State University
  • Prisma Health-Upstate
  • University of California, Los Angeles

Registry information

Official study title

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

Acronym: CRADLE

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Dec 29, 2015
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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