Post-traumatic Stress Disorder in Spontaneous Abortion
Symptoms of Post-traumatic Stress Disorder Complicating Spontaneous Abortion
1 other identifier
observational
200
1 country
1
Brief Summary
The objective of this questionnaire-based study is to prospectively assess the prevalence of post-traumatic stress disorder (PTSD) symptoms in a population of women who have experienced a spontaneous miscarriage during the first trimester of pregnancy. The investigation into the prevalence of PTSD symptoms will assist in better identifying women who may benefit from early psychological intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
December 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
December 29, 2025
December 1, 2025
2 years
December 14, 2025
December 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Impact of Event Scale - Revised (IES-R) score
The score obtained from the Impact of Event Scale - Revised (IES-R) questionnaire has a scoring range of 0 to 88 points, with symptom classification according to the following scheme: - 0-23 points: No or mild symptoms - 24-32 points: A significant number of symptoms - 33 points or more: Most symptoms characteristic of PTSD.
up to 3 months
Posttraumatic Stress Disorder Checklist - Specific (PCL-S) score
The score obtained from Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaire has a scoring range of 17-85 points, with symptom classification according to the following scheme: - 17-29 points: No or few PTSD symptoms - 30-44 points: Moderate to moderately high PTSD symptoms - 45-85 points: Numerous PTSD symptoms.
up to 3 months
Trauma Recovery Measure (TRM) score
The stage of recovery is presented based on the distance of the score from the mean. There are three possible stages of recovery: - Early Stage of Recovery: Less than 1 standard deviation below the mean (total score of 31 or fewer). - Middle Stage of Recovery: Total score ranging from 32 to 61. - Late Stage of Recovery: More than 1 standard deviation above the mean (total score of 62 or more).
up to 3 months
Study Arms (1)
Women who experienced a spontaneous miscarriage during the first trimester of pregnancy
Recruitment will take place at the Department of Endocrinology and Gynecology at the University Hospital in Kraków, located at ul. Kopernika 23, 31-501 Kraków, and at the Department of Gynecology and Gynecological Oncology NSSU, located at Jakubowskiego 2, 30-688 Kraków. The study plans to enroll 200 women aged 18 to 45 years who have been hospitalized due to a spontaneous miscarriage.
Interventions
The test consists of 22 questions that relate to the respondent's feelings, behaviors, and thoughts concerning the traumatic event over the past seven days. For each question, respondents will indicate one of five responses that best reflects their experience: 0 - Not at all 1. \- A little 2. \- Moderately 3. \- Often 4. \- Very often Upon completion of all questions and totaling the points, the scale for symptoms is classified as follows: 0-23 points: No or mild symptoms 24-32 points: A significant number of symptoms 33 points or more: Most symptoms characteristic of PTSD.
This test includes 17 questions related to the behaviors and feelings of the respondent over the past month. Each question is answered using a 5-point scale with assigned points: Not at all - 1 point Sometimes - 2 points Moderately often - 3 points Often - 4 points Very often - 5 points After totaling the points, they are classified as follows: 17-29 points: No or few PTSD symptoms 30-44 points: Moderate to moderately high PTSD symptoms 45-85 points: Numerous PTSD symptoms.
The stage of recovery is presented based on the distance of the score from the mean. There are three possible stages of recovery: * Early Stage of Recovery: Less than 1 standard deviation below the mean (total score of 31 or fewer). * Middle Stage of Recovery: Total score ranging from 32 to 61. * Late Stage of Recovery: More than 1 standard deviation above the mean (total score of 62 or more).
Eligibility Criteria
The prospective survey study will include women receiving treatment in the Department of Endocrinology and Gynecology, as well as the Department of Gynecology and Gynecological Oncology at the University Hospital in Kraków, due to spontaneous abortion diagnosed by the 14th week of gestation. The study plans to enroll 200 women aged 18 to 45 years.
You may qualify if:
- spontaneous abortion
- gestational age up to 14 weeks.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, Malopolska, 31-501, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iwona Gawron, PhD, MD
Jagiellonian University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
December 14, 2025
First Posted
December 29, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
December 29, 2025
Record last verified: 2025-12