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NCT Number: NCT07306676

Post-traumatic Stress Disorder in 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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

  • - 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • spontaneous abortion
  • gestational age up to 14 weeks.

Exclusion criteria

  • none

Treatment and study plan

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

Diagnostic Test

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.

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

Diagnostic Test

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.

Trauma Recovery Measure (TRM) questionnaire

Diagnostic Test

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).

Primary outcomes

  1. Impact of Event Scale - Revised (IES-R) score

    Time frame: up to 3 months

    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.

  2. Posttraumatic Stress Disorder Checklist - Specific (PCL-S) score

    Time frame: up to 3 months

    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.

  3. Trauma Recovery Measure (TRM) score

    Time frame: up to 3 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Iwona Gawron, PhD, MD

CONTACT

[email protected]

+48 12424870

Robert Jach, Prof., PhD

CONTACT

[email protected]

+48 12424871

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Symptoms of Post-traumatic Stress Disorder Complicating Spontaneous Abortion

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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