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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.
The aim of the study will be to evaluate the interest of a short early psychological care in women with miscarriage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "short early psychological care" group | Experimental | Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife |
|
| "control" group | Active Comparator | Women with encouragement of early support consultation with generalist practitioner or midwife |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife | Other | 4 consultations with a psychologist over 2 months maximum |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aline Hurtaud, Dr | Contact | 0326918822 | +33 | aline.ohl-hurtaud@univ-reims.fr |
| CURRS CURRS | Contact | 0326918822 | +33 | currs@univ-reims.fr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37924101 | Derived | Barbe C, Boiteux-Chabrier M, Charillon E, Bouazzi L, Maheas C, Merabet F, Graesslin O, Auer J, Hammami S, Rolland AC, Hurtaud A. Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial. BMC Psychol. 2023 Nov 3;11(1):368. doi: 10.1186/s40359-023-01421-x. |
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| encouragement of early support consultation with generalist practitioner or midwife | Other | encouragement of early support consultation with generalist practitioner or midwife |
|
| 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 |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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