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Interest of a Short Early Psychological Care in Women With Miscarriage (MisTher)

Primary Purpose

Miscarriage

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
encouragement of early support consultation with generalist practitioner or midwife
Sponsored by
Université de Reims Champagne-Ardenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Miscarriage focused on measuring Miscarriage, Psychological care, Anxiety, Depression, Post traumatic stress disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: women with an early miscarriage (defined by a spontaneous termination of pregnancy before the 14th week of amenorrhea) women aged more than 18 women agreeing to participate in the study (signing the informed consent form). Exclusion Criteria: ectopic pregnancy molar pregnancy women with recurrent miscarriages women less than 18

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    "short early psychological care" group

    "control" group

    Arm Description

    Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife

    Women with encouragement of early support consultation with generalist practitioner or midwife

    Outcomes

    Primary Outcome Measures

    anxiety
    Anxiety will be evaluated using the Scale Trait Anxiety Inventory version Y (STAI-Y-A). The STAI Form Y-A consists of a set of twenty item sonly focus on the psychological and not the somatic aspects of anxiety. The STAI Form Y-A is a self-reported questionnaire. Each item is scored from 1 to 4 and a sum score of all items is computed. Higher score indicates greater anxiety. Presence of anxiety will be defined by a score greater than or equal to 46.

    Secondary Outcome Measures

    depression
    depression will be evaluated using Beck Depression Inventory - Second Edition (BDI-II). The BDI-II is a self-reported index of depressive symptoms experienced in the past 2 weeks. The questionnaire includes 21 items of depression symptoms and attitude that the subjects must answer on a 4-point scale from 0 to 3 (0 = not at all bothered; 3 = severely bothered). The minimum score in this questionnaire is 0 and the maximum is 63. Total score indicates that depression is minimal (from 0 to 11 points), mild (from 12 to 19 points), moderate (from 20 to 35 points), or severe (from 36 to 63 points). Presence of depression will be defined by a score greater than or equal to 19.
    anxiety
    Anxiety will be evaluated using the Scale Trait Anxiety Inventory version Y (STAI-Y-A). The STAI Form Y-A consists of a set of twenty item sonly focus on the psychological and not the somatic aspects of anxiety. The STAI Form Y-A is a self-reported questionnaire. Each item is scored from 1 to 4 and a sum score of all items is computed. Higher score indicates greater anxiety. Presence of anxiety will be defined by a score greater than or equal to 46.
    depression
    depression will be evaluated using Beck Depression Inventory - Second Edition (BDI-II). The BDI-II is a self-reported index of depressive symptoms experienced in the past 2 weeks. The questionnaire includes 21 items of depression symptoms and attitude that the subjects must answer on a 4-point scale from 0 to 3 (0 = not at all bothered; 3 = severely bothered). The minimum score in this questionnaire is 0 and the maximum is 63. Total score indicates that depression is minimal (from 0 to 11 points), mild (from 12 to 19 points), moderate (from 20 to 35 points), or severe (from 36 to 63 points). Presence of depression will be defined by a score greater than or equal to 19.

    Full Information

    First Posted
    December 7, 2022
    Last Updated
    May 11, 2023
    Sponsor
    Université de Reims Champagne-Ardenne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05653414
    Brief Title
    Interest of a Short Early Psychological Care in Women With Miscarriage
    Acronym
    MisTher
    Official Title
    Interest of a Short Early Psychological Care in Women With Miscarriage: a Controlled Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 30, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Université de Reims Champagne-Ardenne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Miscarriage is a very common complication of pregnancy, accounting for 15.3% (95% CI 12.5-18.7%) of diagnosed pregnancies. Miscarriage would affect one in ten women during her lifetime. Worldwide, 23 million miscarriages occur annually. Because of its frequency, miscarriage isoften considered as trivial event by caregivers. Still, miscarriage can be a traumatic event. Literature is consistent on the psychological morbidity associated with miscarriage. Anxiety, depression, post-traumatic stress have been studied in women after miscarriage. Cohort studies and clinical trials suggest that psychological and supportive interventions performed in women after miscarriage may improve women's psychological well-being and reduce miscarriage complications in subsequent pregnancies. However, to date, the literature is considered insufficient on the psychological care of women after a miscarriage.
    Detailed Description
    The aim of the study will be to evaluate the interest of a short early psychological care in women with miscarriage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Miscarriage
    Keywords
    Miscarriage, Psychological care, Anxiety, Depression, Post traumatic stress disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    932 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    "short early psychological care" group
    Arm Type
    Experimental
    Arm Description
    Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
    Arm Title
    "control" group
    Arm Type
    Active Comparator
    Arm Description
    Women with encouragement of early support consultation with generalist practitioner or midwife
    Intervention Type
    Other
    Intervention Name(s)
    short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
    Intervention Description
    4 consultations with a psychologist over 2 months maximum
    Intervention Type
    Other
    Intervention Name(s)
    encouragement of early support consultation with generalist practitioner or midwife
    Intervention Description
    encouragement of early support consultation with generalist practitioner or midwife
    Primary Outcome Measure Information:
    Title
    anxiety
    Description
    Anxiety will be evaluated using the Scale Trait Anxiety Inventory version Y (STAI-Y-A). The STAI Form Y-A consists of a set of twenty item sonly focus on the psychological and not the somatic aspects of anxiety. The STAI Form Y-A is a self-reported questionnaire. Each item is scored from 1 to 4 and a sum score of all items is computed. Higher score indicates greater anxiety. Presence of anxiety will be defined by a score greater than or equal to 46.
    Time Frame
    Month 3
    Secondary Outcome Measure Information:
    Title
    depression
    Description
    depression will be evaluated using Beck Depression Inventory - Second Edition (BDI-II). The BDI-II is a self-reported index of depressive symptoms experienced in the past 2 weeks. The questionnaire includes 21 items of depression symptoms and attitude that the subjects must answer on a 4-point scale from 0 to 3 (0 = not at all bothered; 3 = severely bothered). The minimum score in this questionnaire is 0 and the maximum is 63. Total score indicates that depression is minimal (from 0 to 11 points), mild (from 12 to 19 points), moderate (from 20 to 35 points), or severe (from 36 to 63 points). Presence of depression will be defined by a score greater than or equal to 19.
    Time Frame
    month 3
    Title
    anxiety
    Description
    Anxiety will be evaluated using the Scale Trait Anxiety Inventory version Y (STAI-Y-A). The STAI Form Y-A consists of a set of twenty item sonly focus on the psychological and not the somatic aspects of anxiety. The STAI Form Y-A is a self-reported questionnaire. Each item is scored from 1 to 4 and a sum score of all items is computed. Higher score indicates greater anxiety. Presence of anxiety will be defined by a score greater than or equal to 46.
    Time Frame
    month 6
    Title
    depression
    Description
    depression will be evaluated using Beck Depression Inventory - Second Edition (BDI-II). The BDI-II is a self-reported index of depressive symptoms experienced in the past 2 weeks. The questionnaire includes 21 items of depression symptoms and attitude that the subjects must answer on a 4-point scale from 0 to 3 (0 = not at all bothered; 3 = severely bothered). The minimum score in this questionnaire is 0 and the maximum is 63. Total score indicates that depression is minimal (from 0 to 11 points), mild (from 12 to 19 points), moderate (from 20 to 35 points), or severe (from 36 to 63 points). Presence of depression will be defined by a score greater than or equal to 19.
    Time Frame
    month 6

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: women with an early miscarriage (defined by a spontaneous termination of pregnancy before the 14th week of amenorrhea) women aged more than 18 women agreeing to participate in the study (signing the informed consent form). Exclusion Criteria: ectopic pregnancy molar pregnancy women with recurrent miscarriages women less than 18
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aline Hurtaud, Dr
    Phone
    0326918822
    Ext
    +33
    Email
    aline.ohl-hurtaud@univ-reims.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    CURRS CURRS
    Phone
    0326918822
    Ext
    +33
    Email
    currs@univ-reims.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Interest of a Short Early Psychological Care in Women With Miscarriage

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