Spontaneous AbortionNCT07306676
Post-traumatic Stress Disorder in Spontaneous Abortion
An observational study of Spontaneous Abortion, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Spontaneous Abortion
- What is being tested?
- Impact of Event Scale - Revised (IES-R) questionnaire, Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaire and Trauma Recovery Measure (TRM) questionnaire
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 15 Dec 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- spontaneous abortion
- gestational age up to 14 weeks.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, Malopolska, 31-501
Iwona M Gawron, MD, PhD, +48 124248570, iwona.gawron@uj.edu.pl
Robert Jach, Prof., PhD, +48 124248571, jach@cm-uj.krakow.pl
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Spontaneous Abortion
- Being tested
- Impact of Event Scale - Revised (IES-R) questionnaire, Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaire, Trauma Recovery Measure (TRM) questionnaire
- Keywords
- Spontaneous Abortion, PTSD
- Medical subject headings
- Abortion, Spontaneous, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of Event Scale - Revised (IES-R) questionnaireDiagnostic 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) questionnaireDiagnostic 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) questionnaireDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Iwona Gawron, PhD, MD, Study director, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306676
- Sponsor's protocol ID
- 118.0043.1.343.2025
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms of Post-traumatic Stress Disorder Complicating Spontaneous Abortion
- ClinicalTrials.gov ID
- NCT07306676
- Acronym / sponsor ID
- 118.0043.1.343.2025
- Conditions
- Spontaneous Abortion
- Keywords
- Spontaneous Abortion, PTSD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who experienced a spontaneous miscarriage during the first trimester of pregnancy | – | 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) questionnaireRecruitment 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- spontaneous abortion
- gestational age up to 14 weeks.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of Event Scale - Revised (IES-R) questionnaireThe 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 | Women who experienced a spontaneous miscarriage during the first trimester of pregnancy |
| Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaireThis 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 | Women who experienced a spontaneous miscarriage during the first trimester of pregnancy |
| Trauma Recovery Measure (TRM) questionnaireThe 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). | Diagnostic test | Women who experienced a spontaneous miscarriage during the first trimester of pregnancy |
Primary outcome
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iwona Gawron, PhD, MD study director
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Abortion, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iwona Gawron, PhD, MD (+48 12424870, iwona.gawron@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Event Scale - Revised (IES-R) score (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.