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NCT03904979 · ClinicalTrials.gov registry record · NA
Therapeutic Writing to Reduce Stress
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT03904979 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 15 participants.
The verdict
NCT03904979, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Purpose: The investigators hypothesize that exposure to chronic environmental stress is a risk factor for adverse pregnancy outcomes related to preterm birth and preeclampsia among high-risk pregnant women. Additionally, the investigators hypothesize that women can be screened for high levels of environmental stress through the perceived stress scale, and therapeutic writing can be used as a low-resource intervention to help decrease maternal perceived stress and inflammation - measured through analysis of maternal serum and placental samples. Participants: Pregnant women at high risk for adverse pregnancy outcomes, including pre-eclampsia and preterm birth, enrolled in prenatal care at UNC will be recruited for participation Procedures: Using results from the perceived stress scale, the investigators will identify women who screen positive for high environmental stress. Women meeting inclusion criteria will be contacted for possible participation at regularly scheduled prenatal visits. Women who are enrolled will be randomized to generalized writing prompts, therapeutic writing prompts, or no writing during their pregnancy to be administered at each prenatal visit. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Delivery outcomes will be obtained through medical record review.
Interventions
- OTHER Writing exercises
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2022-02-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03904979
The ClinicalTrials.gov registry entry for NCT03904979 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Writing exercises is the first listed.
NCT03904979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03904979 about?
NCT03904979 is a clinical study titled "Therapeutic Writing to Reduce Stress". Purpose: The investigators hypothesize that exposure to chronic environmental stress is a risk factor for adverse pregnancy outcomes related to preterm birth and preeclampsia among high-risk pregnant women. Additionally, the investigators hypothesize that women can be screened for high levels of env...
What is the current status of trial NCT03904979?
This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2019-10-22. Estimated completion is 2022-02-17.
What interventions are being tested in trial NCT03904979?
The interventions under investigation include: Writing exercises (OTHER).
Who is sponsoring clinical trial NCT03904979?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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