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NCT03664128 · ClinicalTrials.gov registry record
Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 157
- Enrollment target
NCT03664128: Completed study, sponsored by Johns Hopkins University.
NCT03664128 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 157 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664128 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 157 participants
- Enrollment target
Study Summary
The aim of the proposed research is to identify the clinical and biological phenotypes that define perinatal anxiety. The importance of this research to public health is that it will help to identify women at high risk, and will also serve as the basis for further studies that would identify genetic and epigenetic markers of risk and lead to research to identify novel treatment targets. The research is based upon preliminary data demonstrating a relationship between inflammatory cytokines and Trait anxiety in pregnancy; between progesterone and postpartum anxiety; and between allopregnanolone and obsessive symptoms in pregnancy. The proposed research will build upon these preliminary findings by prospectively examining the clinical features of anxiety in a cohort of pregnant women and healthy matched controls, and by analyzing blood samples from the same cohort for inflammatory cytokines, reproductive hormones, and immune cell types. The proposed study will therefore identify the clinical and biological phenotypes that characterize perinatal anxiety and will identify potential novel targets for treatment.
Primary Outcome
The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of IL-6 in pg/mL. Concentration will be log-transformed.
Interventions
- OTHER Coping with Anxiety through Living Mindfully (CALM) Pregnancy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2016-06-24 |
| Est. Completion | 2022-11-28 |
What the finished NCT03664128 record still lists
NCT03664128 is an observational study that tracks outcomes without assigning an intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Coping with Anxiety through Living Mindfully (CALM) Pregnancy is the first listed.
NCT03664128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03664128 about?
NCT03664128 is a clinical study titled "Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems". The aim of the proposed research is to identify the clinical and biological phenotypes that define perinatal anxiety. The importance of this research to public health is that it will help to identify women at high risk, and will also serve as the basis for further studies that would identify genetic...
What is the current status of trial NCT03664128?
This trial is currently completed. The enrollment target is 157 participants. The study started on 2016-06-24. Estimated completion is 2022-11-28.
What interventions are being tested in trial NCT03664128?
The interventions under investigation include: Coping with Anxiety through Living Mindfully (CALM) Pregnancy (OTHER).
Who is sponsoring clinical trial NCT03664128?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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