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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04154423
Other study ID # AD-2018C2-13227
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 7, 2019
Est. completion date November 1, 2024

Study information

Verified date June 2024
Source University of California, San Francisco
Contact Miriam Kuppermann, PhD, MPH
Phone (415) 502-4089
Email miriam.kuppermann@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 657 Medi-Cal eligible pregnant individuals 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 less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth.


Recruitment information / eligibility

Status Recruiting
Enrollment 657
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Between 8 and 24 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

Study Design


Intervention

Other:
Glow! Group Prenatal Care
Glow! is an enhanced group prenatal care model that offers co-located social services provided by established community programs with independent funding streams targeting low-income families. The Glow! group prenatal care model pairs a trained facilitator with a licensed prenatal care practitioner from a practice site to provide billable prenatal care to the practice's own patients. Over the course of 8-10 sessions, 10-12 women (within a 6- week gestational age range) receive prenatal medical care, risk assessments, and social support, and gain knowledge and skills related to pregnancy, birth, and parenting.
Individual Prenatal Care with CPSP
Comprehensive Perinatal Services Program (CPSP) is a state-funded program for Medi-Cal eligible families to receive enhanced care and service coordination. Participants assigned to CPSP individual care may participate in the CPSP assessments with a Comprehensive Perinatal Health Worker at their prenatal care site, where individual prenatal care will be provided

Locations

Country Name City State
United States Central Valley Health Policy Institute Fresno California
United States UCSF San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco California State University, Fresno Foundation, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Patient Health Questionnaire (PHQ-9) Score Changes in depressive symptom severity from baseline to postpartum. Assessed using the Patient Health Questionnaire (PHQ-9), administered in-person at baseline and during telephone interview at three months postpartum. Total score ranges from 0-27 with higher scores indicating more severe depression. Collected from study enrollment to three months postpartum
Primary Person-centered prenatal care This outcome focuses on the extent to which the participants feels their prenatal care was person centered.
The title of the measure is Person Centered Prenatal Care (primary). This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages.
The total scores range from 0-100 with higher scores indicating the receipt of more person centered care.
Collected during third trimester
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
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, administered in-person at baseline and during telephone interview at three months postpartum.
The total scores range from 0-21 with higher scores indicating more severe anxiety.
Collected from study enrollment to three months postpartum
Secondary Perceptions of respectful/disrespectful maternity care Extent to which the participant feels that the maternity care they received was respectful. Assessed using the Mothers on Respect Index (MORi), administered during telephone interview or in-person at third trimester and three months postpartum.
The total scores range from 14-84 with higher scores indicating a higher level of respect.
Collected at 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 Scale, administered during telephone interview or in-person interview at third trimester and three months postpartum.
The total scores range from 0-100 with higher scores indicating higher levels of satisfaction.
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 Person Centered Maternity Care as measured at 3 months postpartum. Extent to which birthing person feels their prenatal and birthing experience was person centered, as measured by the Person-Centered Maternity Care scale.
This measure focuses on the extent to which the participants feels their prenatal and maternity/birthing care was person centered.
The title of the measure is Person Centered Maternity Care. This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages.
The total scores range from 0-100 with higher scores indicating the receipt of more person centered care.
3 months postpartum
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