Preeclampsia Research on Vitamin D, Inflammation, & Depression

NCT03018132 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-07

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018132 on ClinicalTrials.gov