Post-traumatic Stress Disorder in Spontaneous Abortion

Symptoms of Post-traumatic Stress Disorder Complicating Spontaneous Abortion

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.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Abortion
• Intervention / Treatment: Diagnostic test: Impact of Event Scale - Revised (IES-R) questionnaire; Diagnostic test: Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaire; Diagnostic test: Trauma Recovery Measure (TRM) questionnaire

Detailed Description

A questionnaire-based study will be conducted with prospective inclusion of participants, based on the analysis of medical documentation and self-administered questionnaires. The following questionnaires are proposed for use:

i. Impact of Event Scale - Revised (IES-R) is a 22-item test that measures the level of stress and anxiety resulting from traumatic events. It is utilized as a screening tool in diagnosing post-traumatic stress disorder (PTSD). 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. The questionnaire will be completed during hospitalization.

ii. Posttraumatic Stress Disorder Checklist - Specific (PCL-S) is a 17-item test designed to detect symptoms of PTSD resulting from a specific traumatic event. 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 questionnaire will be completed during a routine follow-up visit at the outpatient clinic eight weeks post-discharge from the hospital.

iii. Trauma Recovery Measure (TRM) is a 15-item tool designed to assess trauma and the recovery process. It enables a structured evaluation of the multifaceted impact of trauma on an individual, facilitating the adjustment of support and intervention strategies.

The TRM provides a total score as well as three subscale scores that assess the cognitive aspects of the individual following the experience of traumatic events. The three subscales within the TRM include:

• Validation: This subscale measures the acceptance and self-acceptance of the trauma survivor as they are, despite the traumatic experience, and evaluates the development of internal worth and dignity.
• Liberation: This subscale assesses the survivor's ability to free themselves from control, entrapment, and/or oppression caused by the trauma, and their capacity to live in a way that allows them to feel empowered and confident in making positive decisions for themselves and others.
• Positive Self: This subscale measures the presence of positive cognitive aspects that generate feelings of care, compassion, and/or kindness.

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).

The questionnaire will be completed during a routine follow-up visit at the outpatient clinic eight weeks post-discharge from the hospital.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Iwona Gawron, PhD, MD; Phone Number: +48 12424870; Email: iwona.gawron@uj.edu.pl
• Study Contact Backup: Name: Robert Jach, Prof., PhD; Phone Number: +48 12424871; Email: jach@cm-uj.krakow.pl

Study Locations

• Poland
  • Malopolska
    • Krakow, Malopolska, Poland, 31-501
      • Recruiting
      • Jagiellonian University Medical College, Department of Gynecology and Obstetrics
      • Contact: Robert Jach, Prof., PhD; Phone Number: +48 124248571; Email: jach@cm-uj.krakow.pl
      • Contact: Iwona M Gawron, MD, PhD; Phone Number: +48 124248570; Email: iwona.gawron@uj.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• spontaneous abortion
• gestational age up to 14 weeks.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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; - A little; - Moderately; - Often; - 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Director: Iwona Gawron, PhD, MD, Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; Spontaneous Abortion
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Stress Disorders, Traumatic; Abortion, Spontaneous; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 118.0043.1.343.2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No