Vitamin D for Preeclampsia

(PROVIDE Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Antipsychotics, others

Disqualifiers: Psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how vitamin D might reduce inflammation linked to preeclampsia (a condition during pregnancy marked by high blood pressure and swelling) and postpartum depression (depression after childbirth). It also examines how early mental health screening and education can help pregnant women lower the risk of postpartum depression. The study is open to pregnant women in their third trimester who are patients at Cedars-Sinai Medical Center in Los Angeles. Participants will engage in a mental health screening and education program.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance maternal health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mental health screening, education, and referral program is safe?

Research shows that vitamin D is generally safe for people. Most studies find serious side effects to be rare. Some individuals might experience minor issues like a mild stomach upset, but this is uncommon. The FDA has approved vitamin D for other uses, indicating its safety for most people.

The mental health program in this trial does not involve medication, so participants will not experience physical side effects. They will learn about mental health, which can be beneficial.

Overall, current research and past studies consider the treatments in this trial safe.

Why are researchers excited about this trial?

Unlike traditional treatments for preeclampsia, which often involve medication to manage blood pressure and prevent seizures, this approach focuses on a mental health screening, education, and referral program. Researchers are excited about this trial because it explores the potential impact of mental health and education interventions on pregnancy outcomes. By addressing mental health and providing education, this approach aims to improve overall maternal health, potentially reducing the incidence or severity of preeclampsia. This could lead to a broader understanding of how holistic care impacts pregnancy, offering new pathways for managing the condition beyond just medication.

What evidence suggests that this mental health screening program is effective for reducing postpartum depression?

Studies have shown that education and counseling programs can positively affect pregnant women at risk of preeclampsia. Research indicates that these programs help women adopt healthier lifestyle habits, even if they don't directly lower the risk of preeclampsia. One study found that counseling improved women's knowledge and awareness about preeclampsia. In this trial, all participants will receive a mental health screening, education, and referral intervention. These findings suggest that such programs might support healthier pregnancies and could also help with related conditions, like postpartum depression. ^{1 2 3 4 5}

Who Is on the Research Team?

Eynav Accortt, PhD

Principal Investigator

Cedars Sinai Medical Center Department of OBGYN

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 or older, patients at Cedars Sinai Medical Center in Los Angeles, between 20-40 weeks of gestation (mainly recruited at the start of the third trimester), who prefer English or Spanish.

Inclusion Criteria

I am pregnant and between 20 to 40 weeks along, mostly in my third trimester.

Patient at Cedars Sinai Medical Center, Los Angeles, CA

I am female.

Exclusion Criteria

I have never been diagnosed with psychosis.

Current substance abuse (evident either via medical intake, or in clinical assessment - SCID)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mental health screening, education, and referral intervention

5 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum assessments at 4 weeks and 3 months

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mental Health Screening, Education and Referral Program

Trial Overview The study investigates vitamin D's anti-inflammatory effects on preeclampsia and depression during pregnancy. It also tests a mental health screening, education, and referral program to prevent postpartum depression.

How Is the Trial Designed?

Group I: Mental Health Screening Education and Referral Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Maternal Mental Health NOW

Collaborator

Trials

2

Recruited

350+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9335477/

The effectiveness of psycho-educational counseling in ... The purpose of this study was to review the effectiveness of psycho-educational counseling in pregnant women with preeclampsia. The methods of this study were ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34792926/

The Effect of an Education and Counseling Program on ... Results: Education and counseling about preeclampsia had a statistically significant effect on healthy lifestyle behaviors (P < .008). However, we found no ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/22799036221104161

The effectiveness of psycho-educational counseling in ... The purpose of this study was to review the effectiveness of psycho-educational counseling in pregnant women with preeclampsia. The methods of ...

4. researchgate.net researchgate.net/publication/354794536_The_Effect_of_an_Education_and_Counseling_Program_on_MaternalNeonatal_Outcomes_in_Pregnant_Women_at_Risk_of_Preeclampsia

The Effect of an Education and Counseling Program on ... A preeclampsia education and counseling program could help to develop healthy lifestyle behaviors in pregnant women at risk of preeclampsia.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06373367

Preeclampsia Educational Program Study (PrEPS) This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.