Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05653414

Interest of a Short Early Psychological Care in Women With Miscarriage

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Miscarriage Abortion, Spontaneous Anxiety Disorders Behavior Behavioral Symptoms Depression Female Urogenital Diseases and Pregnancy Complications Mental Disorders Pregnancy Complications Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

4 consultations with a psychologist over 2 months maximum

encouragement of early support consultation with generalist practitioner or midwife

Other

encouragement of early support consultation with generalist practitioner or midwife

Primary outcomes

  1. anxiety

    Time frame: 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 outcomes

  1. depression

    Time frame: month 3

    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.

  2. anxiety

    Time frame: 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.

  3. depression

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aline Hurtaud, Dr

CONTACT

[email protected]

0326918822 ext. +33

CURRS CURRS

CONTACT

[email protected]

0326918822 ext. +33

Sponsors and collaborators

Lead sponsor

Université de Reims Champagne-Ardenne

Other

Registry information

Official study title

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

Acronym: MisTher

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 16, 2022
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.