Interest of a Short Early Psychological Care in Women With Miscarriage
NCT ID: NCT05653414
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
932 participants
INTERVENTIONAL
2023-05-30
2026-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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"short early psychological care" group
Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
4 consultations with a psychologist over 2 months maximum
"control" group
Women with encouragement of early support consultation with generalist practitioner or midwife
encouragement of early support consultation with generalist practitioner or midwife
encouragement of early support consultation with generalist practitioner or midwife
Interventions
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short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
4 consultations with a psychologist over 2 months maximum
encouragement of early support consultation with generalist practitioner or midwife
encouragement of early support consultation with generalist practitioner or midwife
Eligibility Criteria
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Inclusion Criteria
* women aged more than 18
* women agreeing to participate in the study (signing the informed consent form).
Exclusion Criteria
* molar pregnancy
* women with recurrent miscarriages
* women less than 18
18 Years
FEMALE
Yes
Sponsors
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Université de Reims Champagne-Ardenne
OTHER
Responsible Party
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Central Contacts
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References
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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.
Other Identifiers
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2022_RIPH_003_MisTher
Identifier Type: -
Identifier Source: org_study_id
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