Health TrialsbyHealthPanel

Post-traumatic Stress Disorder in Spontaneous Abortion

ConditionSpontaneous Abortion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorJagiellonian University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

spontaneous abortion

gestational age up to 14 weeks.

Disqualifiers

none

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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 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.

  • 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).

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Women who experienced a spontaneous miscarriage during the first trimester of pregnancy3 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jagiellonian University

Lead sponsor

Source ClinicalTrials.gov
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