NCT05653414

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
932

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started May 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
May 2023Dec 2026

First Submitted

Initial submission to the registry

December 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

May 15, 2023

Status Verified

December 1, 2022

Enrollment Period

2.2 years

First QC Date

December 7, 2022

Last Update Submit

May 11, 2023

Conditions

Miscarriage

Keywords

MiscarriagePsychological careAnxietyDepressionPost traumatic stress disorder

Outcome Measures

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.

    Month 3

Secondary Outcomes (3)

  • depression

    month 3

  • anxiety

    month 6

  • depression

    month 6

Study Arms (2)

"short early psychological care" group

EXPERIMENTAL

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

"control" group

ACTIVE COMPARATOR

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

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

Interventions

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

4 consultations with a psychologist over 2 months maximum

"short early psychological care" group
encouragement of early support consultation with generalist practitioner or midwifeOTHER

encouragement of early support consultation with generalist practitioner or midwife

"control" group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • ectopic pregnancy
  • molar pregnancy
  • women with recurrent miscarriages
  • women less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37924101DERIVED

MeSH Terms

Conditions

Abortion, SpontaneousAnxiety DisordersDepressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Central Study Contacts

Aline Hurtaud, Dr

CONTACT

0326918822aline.ohl-hurtaud@univ-reims.fr

CURRS CURRS

CONTACT

0326918822currs@univ-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 16, 2022

Study Start

May 30, 2023

Primary Completion

August 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

May 15, 2023

Record last verified: 2022-12