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NCT01912833 · ClinicalTrials.gov registry record
Study of Exposure to Stress, Postpartum Mood, Adverse Life Events, and Hormonal Function Among Latinas (SEPAH Latina)
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 34
- Enrollment target
NCT01912833: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT01912833 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01912833 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
Study Summary
The purpose of the funded study is to determine a) examine associations among OT levels, stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess whether there are differences between immigrant women and non-immigrant Latina women on these measures; b) quantify whether there is a correlation between ACTH, cortisol, and PPD and whether there are differences between immigrant and non-immigrant Latina women; and c) assess the feasibility of enrolling Latinas into a laboratory-based study that includes the collection of venous blood for measurement of oxytocin, ACTH, and cortisol. Sixty prenatal (34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are between the ages of 18 and 45 will be enrolled. Women with a singleton pregnancy who are Latina, who intend to breastfeed for more than 2 months, who have or do not have a history of depression, and who are willing to be followed for 8 weeks after delivery will be enrolled in the study. Latinas who report maternal or infant disorder that may interfere with breastfeeding; those who endorse substance use, and/or who have or have had a psychiatric disorder (e.g., psychosis or serious personality disorders) other than depression or anxiety will be excluded to minimize risk and confounds with the outcomes of interest.
Primary Outcome
Postpartum depression will be assessed using the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire that helps to identify women who have postpartum depression.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-09 |
What the finished NCT01912833 record still lists
NCT01912833 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01912833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01912833 about?
NCT01912833 is a clinical study titled "Study of Exposure to Stress, Postpartum Mood, Adverse Life Events, and Hormonal Function Among Latinas (SEPAH Latina)". The purpose of the funded study is to determine a) examine associations among OT levels, stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess whether there are differences between immigrant women and non-immigrant Latina women on these measures; b) quantify whe...
What is the current status of trial NCT01912833?
This trial is currently completed. The enrollment target is 34 participants. The study started on 2013-08. Estimated completion is 2014-09.
Who is sponsoring clinical trial NCT01912833?
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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