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Post-traumatic Stress Disorder in Spontaneous Abortion

NCT07306676 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Spontaneous Abortion

Interventions

DIAGNOSTIC_TEST

Impact of Event Scale - Revised (IES-R) questionnaire

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.

DIAGNOSTIC_TEST

Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaire

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.

DIAGNOSTIC_TEST

Trauma Recovery Measure (TRM) questionnaire

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).

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Iwona Gawron, PhD, MD · Jagiellonian University

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306676 on ClinicalTrials.gov