Clinical trial NCT02640638: A RCT of CenteringPregnancy on Birth Outcomes
Official title: Reducing Disparities in Birth Outcomes: a Randomized Controlled Trial of CenteringPregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Preterm Birth
Keywords: Racial disparities
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: Prisma Health-Upstate
name: University of California, Los Angeles
name: Georgia State University
First posted: 2015-12-29
Enrollment: 2350
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Preterm birth
timeFrame: Measured at delivery
Secondary outcomes:
measure: Birth weight
timeFrame: Measured at delivery
measure: APGAR score
timeFrame: Measured at delivery
measure: Gestational weight gain
timeFrame: Measured at delivery
measure: Gestational diabetes incidence
timeFrame: Measured during pregnancy
measure: Gestational hypertension
timeFrame: Measured during pregnancy
measure: Patient activation measure
timeFrame: Measured at <20 week and 32-36 week of gestational age
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Clemson University
name: Moonseong Heo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.