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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,350
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.
UCLA
Los Angeles, California, United States
Georgia State University
Atlanta, Georgia, United States
Clemson University
Clemson, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Preterm birth
Delivery before 37 weeks gestation
Time frame: Measured at delivery
Birth weight
Infant weight (in grams) a birth
Time frame: Measured at delivery
APGAR score
Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration
Time frame: Measured at delivery
Gestational weight gain
Weight gained during pregnancy as compared to medical recommendation
Time frame: 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) 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)
Time frame: Measured during pregnancy
Gestational hypertension
Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart
Time frame: Measured during pregnancy
Patient activation measure
Based on self-reported questionnaire
Time frame: Measured at <20 week and 32-36 week of gestational age
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.