Premature Birth Clinical Trial
— EMBRACEOfficial title:
Comparing Approaches to Enhanced Prenatal Care to Improve Maternal and Child Health in Central CA
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 2,600 Medi-Cal eligible pregnant women in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in lower rates of preterm birth, less depression and anxiety, and more respectful and greater satisfaction with prenatal care.
Status | Recruiting |
Enrollment | 2600 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Between 8 and 20 weeks gestation at enrollment - Eligible for Medi-Cal (at or below 213% of the federal poverty level) - Speak English or Spanish Exclusion Criteria: - Unavailable to attend group prenatal care sessions - Not planning to continue prenatal care with site provider - Cannot legally consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
United States | Central Valley Health Policy Institute | Fresno | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | California State University, Fresno Foundation, Patient-Centered Outcomes Research Institute |
United States,
Krieger N, Smith K, Naishadham D, Hartman C, Barbeau EM. Experiences of discrimination: validity and reliability of a self-report measure for population health research on racism and health. Soc Sci Med. 2005 Oct;61(7):1576-96. doi: 10.1016/j.socscimed.2005.03.006. Epub 2005 Apr 21. — View Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation
Peek ME, Nunez-Smith M, Drum M, Lewis TT. Adapting the everyday discrimination scale to medical settings: reliability and validity testing in a sample of African American patients. Ethn Dis. 2011 Autumn;21(4):502-9. — View Citation
Raube K, Handler A, Rosenberg D. Measuring satisfaction among low-income women: a prenatal care questionnaire. Matern Child Health J. 1998 Mar;2(1):25-33. doi: 10.1023/a:1021841508698. — View Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation
Vedam S, Stoll K, Rubashkin N, Martin K, Miller-Vedam Z, Hayes-Klein H, Jolicoeur G; CCinBC Steering Council. The Mothers on Respect (MOR) index: measuring quality, safety, and human rights in childbirth. SSM Popul Health. 2017 Jan 19;3:201-210. doi: 10.1016/j.ssmph.2017.01.005. eCollection 2017 Dec. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preterm birth | Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record. | 0-12 weeks after delivery | |
Primary | Changes in depressive symptom severity | Changes in depressive symptom severity from baseline to postpartum. Assessed using the Patient Health Questionnaire (PHQ-9) developed by Kroenke et al. (2001), administered in-person at baseline and during telephone interview at three months postpartum. | Collected from study enrollment to three months postpartum | |
Primary | Perceptions of respectful/disrespectful care | Extent to which the participant feels that the prenatal care they received was respectful. Assessed using the Mothers on Respect Index (MORi) developed by Vedam et al. (2017), administered during telephone interview or in-person at third trimester and three months postpartum. | Collected during third trimester and at three months postpartum | |
Secondary | Gestational age at delivery | The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record. | 0-12 weeks after delivery | |
Secondary | Changes in anxiety symptom severity | Changes in anxiety symptom severity from baseline to postpartum. Assessed using the 7-item Generalized Anxiety Disorder (GAD-7) scale developed by Spitzer et al. (2006), administered in-person at baseline and during telephone interview at three months postpartum. | Collected from study enrollment to three months postpartum | |
Secondary | Satisfaction with prenatal care | Extent to which the participant feels satisfied with the prenatal care they received. Assessed using the Prenatal Care Satisfaction (PSQ) Scale developed by Raube et al. (1998), administered during telephone interview or in-person interview at third trimester and three months postpartum. | Collected during third trimester and at three months postpartum |
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