Preeclampsia Research on Vitamin D, Inflammation, & Depression
NCT03018132 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-02-07
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.
Conditions
- Pre-Eclampsia
- Depression
- Inflammation
- Vitamin D Deficiency
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.
Sponsors & Collaborators
-
Maternal Mental Health NOW
collaborator UNKNOWN -
Cedars-Sinai Medical Center
lead OTHER
Principal Investigators
-
Eynav Accortt, PhD · Cedars Sinai Medical Center Department of OBGYN
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-04-01
- Primary Completion
- 2021-07-01
- Completion
- 2025-07-31
Countries
- United States
Study Locations
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