MiscarriageMisTherNCT05653414
Interest of a Short Early Psychological Care in Women With Miscarriage
A study testing short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife and encouragement of early support consultation with generalist practitioner or midwife in people with Miscarriage, run by Université de Reims Champagne-Ardenne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Miscarriage
- What is being tested?
- short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife and encouragement of early support consultation with generalist practitioner or midwife
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 932 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- ectopic pregnancy
- molar pregnancy
- women with recurrent miscarriages
- women less than 18
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
The aim of the study will be to evaluate the interest of a short early psychological care in women with miscarriage.
- Conditions
- Miscarriage
- Being tested
- short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife, encouragement of early support consultation with generalist practitioner or midwife
- Keywords
- Miscarriage, Psychological care, Anxiety, Depression, Post traumatic stress disorder
- Medical subject headings
- Abortion, Spontaneous, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
encouragement of early support consultation with generalist practitioner or midwifeOther
encouragement of early support consultation with generalist practitioner or midwife
| Study group | Role | What they receive |
|---|---|---|
| "short early psychological care" group | Experimental | Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife Receives: 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 Receives: Other: encouragement of early support consultation with generalist practitioner or midwife |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3
Secondary outcomes (3)
depression
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.
Measured: month 3
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.
Measured: month 6
depression
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.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start30 May 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 932 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653414
- Sponsor's protocol ID
- 2022_RIPH_003_MisTher
- Acronym
- MisTher
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37924101
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Short Early Psychological Care in Women With Miscarriage: a Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT05653414
- Acronym / sponsor ID
- MisTher / 2022_RIPH_003_MisTher
- Conditions
- Miscarriage
- Keywords
- Miscarriage, Psychological care, Anxiety, Depression, Post traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 932 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "short early psychological care" group | Experimental | Other: short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwifeWomen with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife |
| "control" group | Active comparator | Other: encouragement of early support consultation with generalist practitioner or midwifeWomen with encouragement of early support consultation with generalist practitioner or midwife |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- ectopic pregnancy
- molar pregnancy
- women with recurrent miscarriages
- women less than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife4 consultations with a psychologist over 2 months maximum | Other | "short early psychological care" group |
| encouragement of early support consultation with generalist practitioner or midwifeencouragement of early support consultation with generalist practitioner or midwife | Other | "control" group |
Primary outcome
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.
3 secondary outcomes
depression
Time frame: month 3
anxiety
Time frame: month 6
depression
Time frame: month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 37924101Barbe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife and encouragement of early support consultation with generalist practitioner or midwife in people with Miscarriage, run by Université de Reims Champagne-Ardenne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline Hurtaud, Dr (0326918822 ext. +33, aline.ohl-hurtaud@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05653414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.