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ACTIVE NOT RECRUITING
NCT03018132
NA

Preeclampsia Research on Vitamin D, Inflammation, & Depression

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

This study is designed to comprehensively investigate the anti-inflammatory role of vitamin D in reproductive aged women, and its association with preeclampsia and depression. Findings will have substantial impact providing new information implicated in the development of preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive fluid, and kidney stress) and postpartum depression (after birth). Additionally, the study is designed to understand how early mental health screening and evaluation can help pregnant women reduce their risk of developing postpartum depression. Testing the acceptability and effectiveness of this mental health screening, education and referral program at Cedars-Sinai Medical Center will provide valuable patient centered qualitative and quantitative data that can be used in future services planning. The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.

Official title: The PROVIDE Study; Preeclampsia Research on Vitamin D, Inflammation, & Depression

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2017-04-01

Completion Date

2027-07

Last Updated

2026-10-21

Healthy Volunteers

Yes

Interventions

OTHER

mental health screening, education and referral program

I. Psychosocial assessments: 1. Mental health screening for: (1) depressive symptoms with the EPDS, (2) post-traumatic stress symptoms with the IES, (3) for perceived stress with the PSS (4) for anxiety with the OASIS. 2. Exercise, smoking \& substance use, sleep and nutrition. II. If women are above cutoff values the SCID will be conducted. III. Education and referral information via Maternal Mental Health NOW: 1. All receive a brochure entitled, Speak Up When You Are Down 2. If above cutoffs, participants will also receive referral information; and will be scheduled for a SCID 3. Trained study staff will review the brochure and show the woman how to use the MMHN online referral system to input their zip code and find preferred maternal mental health practitioners. IV. Follow up with a survey at 3 months postpartum: acceptability of screening, benefit of referral service, and outcome of this referral.

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States