Interest of a Short Early Psychological Care in Women With Miscarriage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Miscarriage. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Interest of a Short Early Psychological Care in Women With Miscarriage: a Controlled Randomized Study
Overview
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.
Interventions
- 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 - Other encouragement of early support consultation with generalist practitioner or midwife
encouragement of early support consultation with generalist practitioner or midwife
Primary outcome measures
- anxiety [Time frame: Month 3]
Secondary outcome measures (3)
- depression [Time frame: month 3]
- anxiety [Time frame: month 6]
- depression [Time frame: month 6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 37924101
Identifiers
NCT: NCT05653414 · 2022_RIPH_003_MisTher