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

Université de Reims Champagne-Ardenne

Status: Not yet enrolling

Conditions: Miscarriage

Treatments: Other: short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife; Other: encouragement of early support consultation with generalist practitioner or midwife

Study type: Interventional

Funder types: Other

Identifiers

NCT05653414

2022_RIPH_003_MisTher

Details and patient eligibility

About

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.

Full description

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

Enrollment: 932 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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932 participants in 2 patient groups

"short early psychological care" group

Experimental group

Description:

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

Treatment:

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

"control" group

Active Comparator group

Description:

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

Treatment:

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