Preeclampsia Research on Vitamin D, Inflammation, & Depression

NCT03018132 | Active Not Recruiting

• 1 other identifier: Pro00044664
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

perinatal mental health

Outcome Measures

Primary Outcomes (2)

• Depressive symptoms

  as measured by reliable and validated screening tool (EPDS)

  5 months

• Depression Diagnosis

  as measured by diagnostic interview (SCID)

  5 months

Secondary Outcomes (9)

• Anxiety symptoms

  5 months

• Post-traumatic stress symptoms

  5 months

• Perceived stress

  5 months

• Acceptability of Mental Health Program

  5 months

• Benefits of Mental Health Program

  5 months

Study Arms (1)

Mental Health Screening Education and Referral

OTHER

Investigators will prospectively assign all 200 women to this screening, education and referral intervention, without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. The health-related intervention, in this case, is an educational program and related process-of-care changes.

Other: mental health screening, education and referral program

Interventions

mental health screening, education and referral program OTHER

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.

Mental Health Screening Education and Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Minimum 18 years of age
• Patient at Cedars Sinai Medical Center, Los Angeles, CA
• Between 20 and 40 weeks gestation (majority recruited at start of 3rd trimester between 26-32 weeks)
• English or Spanish language preference

You may not qualify if:

• Any diagnosis of psychosis, past or current (evident by either meds taken via medical intake, or in clinical assessment - SCID)
• Current substance abuse (evident either via medical intake, or in clinical assessment - SCID)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Maternal Mental Health NOW: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (56)

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Related Links

• Maternal Mental Health NOW Referral Directory

MeSH Terms

Conditions

Pre-Eclampsia; Depression; Inflammation; Vitamin D Deficiency

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Eynav Accortt, PhD

  Cedars Sinai Medical Center Department of OBGYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: January 11, 2017
• Study Start: April 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)