Preeclampsia Research on Vitamin D, Inflammation, & Depression (PROVIDE)
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|ClinicalTrials.gov Identifier: NCT03018132|
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : February 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pre-Eclampsia Depression Inflammation Vitamin D Deficiency||Other: mental health screening, education and referral program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The PROVIDE Study; Preeclampsia Research on Vitamin D, Inflammation, & Depression|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||April 2020|
Mental Health Screening Education and Referral
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
I. Psychosocial assessments:
II. If women are above cutoff values the SCID will be conducted.
III. Education and referral information via Maternal Mental Health NOW:
IV. Follow up with a survey at 3 months postpartum: acceptability of screening, benefit of referral service, and outcome of this referral.
- Depressive symptoms [ Time Frame: 5 months ]as measured by reliable and validated screening tool (EPDS)
- Depression Diagnosis [ Time Frame: 5 months ]as measured by diagnostic interview (SCID)
- Anxiety symptoms [ Time Frame: 5 months ]as measured by the OASIS
- Post-traumatic stress symptoms [ Time Frame: 5 months ]as measured by the IES
- Perceived stress [ Time Frame: 5 months ]as measured by the PSS
- Acceptability of Mental Health Program [ Time Frame: 5 months ]Results will be based on data from structured (Likert-scale) surveys completed at 4 time points, from the patient perspective
- Benefits of Mental Health Program [ Time Frame: 5 months ]Results will be based on data from the follow-up structured (Likert-scale) survey
- Feasibility of Mental Health Program [ Time Frame: 5 months ]The program's feasibility and MMH-Now training will be rated by clinic staff according to structured surveys completed at multiple time points, e.g. pre/post training.
- Inflammation_IL6 [ Time Frame: 5 months ]as measured by serum Interleukin-6
- Inflammation_CRP [ Time Frame: 5 months ]as measured by serum hs_CRP
- Vitamin D deficiency [ Time Frame: 5 months ]as measured by serum 25(OH)D levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018132
|Contact: Eynav E Accortt, PhDfirstname.lastname@example.org|
|Contact: Sarah Kilpatrick, MD, PhDemail@example.com|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Eynav Accortt, PhD 310-423-8744 firstname.lastname@example.org|
|Principal Investigator:||Eynav Accortt, PhD||Cedars Sinai Medical Center Department of OBGYN|