MisTher: Interest of a Short Early Psychological Care in Women With Miscarriage

Sponsor

Université de Reims Champagne-Ardenne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05653414

Collaborator

(none)

932

Enrollment

Arms

40.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Miscarriage	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	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

932 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "short early psychological care" group 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 4 consultations with a psychologist over 2 months maximum
Active Comparator: "control" group Women with encouragement of early support consultation with generalist practitioner or midwife	Other: encouragement of early support consultation with generalist practitioner or midwife encouragement of early support consultation with generalist practitioner or midwife

Arm

Intervention/Treatment

Experimental: "short early psychological care" group

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

4 consultations with a psychologist over 2 months maximum

Active Comparator: "control" group

Women with encouragement of early support consultation with generalist practitioner or midwife

Other: encouragement of early support consultation with generalist practitioner or midwife

encouragement of early support consultation with generalist practitioner or midwife

Outcome Measures

Primary Outcome Measures

anxiety [Month 3]
Anxiety will be evaluated using HADS (Hospital Anxiety and Depression Scale). HADS is a self-administered questionnaire with 7 items evaluating anxiety. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-21. A higher score indicates higher anxiety. Presence of anxiety will be defined by a score greater than or equal to 11.

Secondary Outcome Measures

depression [month 3]
depression will be evaluated using HADS (Hospital Anxiety and Depression Scale). HADS is a self-administered questionnaire with 7 items evaluating depression. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-21. A higher score indicates higher depression. Presence of depression will be defined by a score greater than or equal to 11.
anxiety [month 6]
Anxiety will be evaluated using HADS (Hospital Anxiety and Depression Scale). HADS is a self-administered questionnaire with 7 items evaluating anxiety. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-21. A higher score indicates higher anxiety. Presence of anxiety will be defined by a score greater than or equal to 11.
depression [month 6]
depression will be evaluated using HADS (Hospital Anxiety and Depression Scale). HADS is a self-administered questionnaire with 7 items evaluating depression. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-21. A higher score indicates higher depression. Presence of depression will be defined by a score greater than or equal to 11.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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).