Interest of a Short Early Psychological Care in Women With Miscarriage

NCT ID: NCT05653414

Last Updated: 2023-05-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

932 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2026-12-01

Brief Summary

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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

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

Conditions

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Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife

Intervention Type OTHER

4 consultations with a psychologist over 2 months maximum

"control" group

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

Group Type ACTIVE_COMPARATOR

encouragement of early support consultation with generalist practitioner or midwife

Intervention Type OTHER

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

Intervention Type OTHER

encouragement of early support consultation with generalist practitioner or midwife

encouragement of early support consultation with generalist practitioner or midwife

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Reims Champagne-Ardenne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Aline Hurtaud, Dr

Role: CONTACT

0326918822 ext. +33

CURRS CURRS

Role: CONTACT

0326918822 ext. +33

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.

Reference Type DERIVED
PMID: 37924101 (View on PubMed)

Other Identifiers

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2022_RIPH_003_MisTher

Identifier Type: -

Identifier Source: org_study_id

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