An observational study in Ectopic Pregnancy, sponsored by Jagiellonian University. Recruiting at 2 sites in Poland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Jagiellonian University · Observational
The objective of the study is to prospectively assess the prevalence of post-traumatic stress disorder (PTSD) symptoms in a population of women who have experienced a diagnosis of ectopic pregnancy. The investigation into the prevalence of PTSD symptoms will aid in better identifying women who may benefit from early psychological intervention.
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.
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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 an ectopic pregnancy diagnosed by the 14th week of gestation. The study plans to enroll 200 women aged 18 to 45 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 an ectopic pregnancy diagnosed by the 14th week of gestation. The study plans to enroll 200 women aged 18 to 45 years.
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
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.
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.
15-item tool designed to assess trauma and the recovery process. 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).
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.
Time frame: 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.
Time frame: 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).
Time frame: up to 3 months
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