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NCT03480477 · ClinicalTrials.gov registry record
Adverse Childhood Experiences in Urogynecologic Patients
A clinical trial, sponsored by University of New Mexico.
- Terminated
- Registry status
- 356
- Enrollment target
NCT03480477: Clinical Trial study, sponsored by University of New Mexico.
NCT03480477 is a clinical trial that was terminated before completion, run by University of New Mexico. The registered enrollment target is 356 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03480477 was terminated before completion, sponsored by University of New Mexico.
- TERMINATED
- Registry status
- 356 participants
- Enrollment target
Study Summary
Adverse Childhood Experiences (ACEs) have been associated with negative health outcomes, yet scant information exists regarding the relationship between ACEs, Pelvic floor disorders, and Chronic Pelvic Pain. Pelvic floor disorders (dysfunction of pelvic floor structures) are increasingly common in women, negatively affect their quality of life, and certain of these are refractory to treatment. Despite scattered reports suggesting an association between childhood abuse and specific pelvic floor disorders, the overall association between ACEs \& the spectrum of pelvic floor disorders is unknown. The investigators' previous work suggests that ACEs may be associated with urgency incontinence and work by others suggest ACEs may be associated with Interstitial Cystitis/Bladder Pain Syndrome. These reports are few in number and comprehensive evaluations of ACEs relative to pelvic floor disorders are lacking. The investigators long-term objective is to investigate the relationship between ACEs in patients in the Urogynecologic and Chronic Pelvic Pain population by understanding the contributions to the development of their symptomatology. The current Urogynecology study's Primary Aims are to--1a) Describe the overall prevalence of ACEs, frequency and type of ACEs in a population of women with pelvic floor disorders 1b) Describe differences in ACE prevalence compared to the general population. Secondary Aims are to-2a) Describe ACE types/domains of controls relative to specific pelvic floor diagnoses 2b) Describe their relationship with pelvic floor disorder symptom severity. The investigators central hypothesis is that ACEs are common in women with pelvic floor disorders, that ACE frequency varies by pelvic floor diagnoses, and that ACEs may have profound effects on adult women's quality of life and responsiveness to treatment. The Chronic Pelvic Pain aims, are to 1a) describe the prevalence of ACEs in women with chronic pelvic pain. 1b) To compare the prevalence of ACEs in
Primary Outcome
Report the overall prevalence of ACEs in women with pelvic floor disorders and chronic pelvic pain patients and compare the prevalence of ACEs to a control group
Interventions
- OTHER ACE questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2018-04-09 |
| Est. Completion | 2019-02-01 |
Why NCT03480477 stopped before completion
NCT03480477 is an observational study that tracks outcomes without assigning an intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which ACE questionnaire is the first listed.
NCT03480477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03480477 about?
NCT03480477 is a clinical study titled "Adverse Childhood Experiences in Urogynecologic Patients". Adverse Childhood Experiences (ACEs) have been associated with negative health outcomes, yet scant information exists regarding the relationship between ACEs, Pelvic floor disorders, and Chronic Pelvic Pain. Pelvic floor disorders (dysfunction of pelvic floor structures) are increasingly common in w...
What is the current status of trial NCT03480477?
This trial is currently terminated. The enrollment target is 356 participants. The study started on 2018-04-09. Estimated completion is 2019-02-01.
What interventions are being tested in trial NCT03480477?
The interventions under investigation include: ACE questionnaire (OTHER).
Who is sponsoring clinical trial NCT03480477?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
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