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

May 11, 2023 updated by: Université de Reims Champagne-Ardenne

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

932

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
month 3
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.
month 6
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.
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Reims Champagne-Ardenne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2023

Primary Completion (Anticipated)

August 1, 2025

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_RIPH_003_MisTher

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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