Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, Malopolska, 31-501, Poland
Location status: Recruiting
Location contact
Iwona M Gawron, MD, PhD
CONTACT
Robert Jach, Prof., PhD
CONTACT
NCT Number: NCT07306676
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.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Krakow, Malopolska, 31-501, Poland
Location status: Recruiting
Iwona M Gawron, MD, PhD
CONTACT
Robert Jach, Prof., PhD
CONTACT
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
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:
The stage of recovery is presented based on the distance of the score from the mean. There are three possible stages of recovery:
The questionnaire will be completed during a routine follow-up visit at the outpatient clinic eight weeks post-discharge from the hospital.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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:
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.
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.
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).
Contact information is provided by the study sponsor or research team.
Iwona Gawron, PhD, MD
CONTACT
Robert Jach, Prof., PhD
CONTACT
Jagiellonian University
Other
Symptoms of Post-traumatic Stress Disorder Complicating Spontaneous Abortion
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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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