Miscarriage
Conditions
Keywords
Miscarriage, Psychological care, Anxiety, Depression, Post traumatic stress disorder
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.
Interventions
OTHERshort early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
4 consultations with a psychologist over 2 months maximum
OTHERencouragement of early support consultation with generalist practitioner or midwife
encouragement of early support consultation with generalist practitioner or midwife
Sponsors
Université de Reims Champagne-Ardenne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anxiety | Month 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| depression | month 3 | 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 | month 6 | 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. |
Contacts
Primary ContactAline Hurtaud, Dr
Backup ContactCURRS CURRS
Outcome results
None listed