CRADLE: A RCT of CenteringPregnancy on Birth Outcomes
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CenteringPregnancy group prenatal care Pregnant women who were randomized to receive CenteringPregnancy group prenatal care |
Behavioral: CenteringPregnancy
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.
|
| No Intervention: Traditional individual prenatal care Pregnant women who were randomized to receive traditional individual prenatal care |
Outcome Measures
Primary Outcome Measures
- Preterm birth [Measured at delivery]
Delivery before 37 weeks gestation
Secondary Outcome Measures
- Birth weight [Measured at delivery]
Infant weight (in grams) a birth
- APGAR score [Measured at delivery]
Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration
- Gestational weight gain [Measured at delivery]
Weight gained during pregnancy as compared to medical recommendation
- Gestational diabetes incidence [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)
- Gestational hypertension [Measured during pregnancy]
Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart
- Patient activation measure [Measured at <20 week and 32-36 week of gestational age]
Based on self-reported questionnaire
Eligibility Criteria
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,
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Severe chronic hypertension requiring medication,
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Morbid Obesity with BMI >49.99
-
Renal disease with baseline proteinuria >1g/24 hours
-
Any disease requiring chronic immunosuppression (SLE, solid organ transplant)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA | Los Angeles | California | United States | 90095 |
| 2 | Georgia State University | Atlanta | Georgia | United States | 30303 |
| 3 | Clemson University | Clemson | South Carolina | United States | 29634-0745 |
| 4 | Prisma Health | Greenville | South Carolina | United States | 29605 |
Sponsors and Collaborators
- Clemson University
- Prisma Health-Upstate
- University of California, Los Angeles
- Georgia State University
Investigators
- Principal Investigator: Moonseong Heo, PhD, Clemson University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01HD082311