A RCT of CenteringPregnancy on Birth Outcomes

Pregnancy Clinical Trial

— CRADLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640638
• Other study ID #: R01HD082311
• Status: Completed
• Phase: N/A
• Start date: February 24, 2016
• Est. completion date: January 21, 2021

Study information

• Verified date: August 2022
• Source: Clemson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 prenatal care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2350
• Est. completion date: January 21, 2021
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy
• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia
United States	Clemson University	Clemson	South Carolina
United States	Prisma Health	Greenville	South Carolina
United States	UCLA	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Clemson University	Georgia State University, Prisma Health-Upstate, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth	Delivery before 37 weeks gestation	Measured at delivery
Secondary	Birth weight	Infant weight (in grams) a birth	Measured at delivery
Secondary	APGAR score	Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration	Measured at delivery
Secondary	Gestational weight gain	Weight gained during pregnancy as compared to medical recommendation	Measured at delivery
Secondary	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); 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)	Measured during pregnancy
Secondary	Gestational hypertension	Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart	Measured during pregnancy
Secondary	Patient activation measure	Based on self-reported questionnaire	Measured at <20 week and 32-36 week of gestational age