Interest of a Short Early Psychological Care in Women With Miscarriage
ConditionMiscarriage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversité de Reims Champagne-Ardenne
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
ectopic pregnancy
molar pregnancy
women with recurrent miscarriages
women less than 18
Trial design
Design model
Parallel
Treatments tested in this trial
short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
Other intervention4 consultations with a psychologist over 2 months maximum
encouragement of early support consultation with generalist practitioner or midwife
Other interventionencouragement of early support consultation with generalist practitioner or midwife
Treatment groups
932 Participants
are divided into 2 treatment groupsGroup A: "short early psychological care" groupExperimental treatment 1 intervention
Group B: "control" groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Month 3Secondary outcomes
1
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.
Time frame
month 32
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.
Time frame
month 63
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.
Time frame
month 6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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