Interest of a Short Early Psychological Care in Women With Miscarriage

Study Overview
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Brief Summary
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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
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The aim of the study will be to evaluate the interest of a short early psychological care in women with miscarriage.

Official Title
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Interest of a Short Early Psychological Care in Women With Miscarriage: a Controlled Randomized Study

Conditions
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Miscarriage

Intervention / Treatment
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* Other: short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
* Other: encouragement of early support consultation with generalist practitioner or midwife


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: short early psychological care group<br>Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife | Other: short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife<br>* 4 consultations with a psychologist over 2 months maximum<br>|
| Active Comparator: control group<br>Women with encouragement of early support consultation with generalist practitioner or midwife | Other: encouragement of early support consultation with generalist practitioner or midwife<br>* encouragement of early support consultation with generalist practitioner or midwife<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | month 3 | 
| 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. | month 6 | 
| 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. | month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Miscarriage, Psychological care, Anxiety, Depression, Post traumatic stress disorder