Interest of a Short Early Psychological Care in Women With Miscarriage

Not Applicable

Not yet recruiting

• Conditions: Miscarriage
• Interventions: 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

• Registration Number: NCT05653414
• Lead Sponsor: Université de Reims Champagne-Ardenne

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.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15
• Study Start: 2023-05-30
• Primary Completion: 2025-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 932

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"short early psychological care" group	short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife	Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife
"control" group	encouragement of early support consultation with generalist practitioner or midwife	Women with encouragement of early support consultation with generalist practitioner or midwife

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
depression	month 6	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.