MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Mental Health Wellness 1; Pregnancy

Treatments: Behavioral: Integrated approach to pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT03839004

MYND&CO

Details and patient eligibility

About

To evaluate an integral approach to the maternal-fetal diad.

A randomized non farmacological monocentric trial.

400 women with single spontaneous pregnancies are randomized.

200 recieve standardized traditional obstetrical care

200 recieve nutritional advice, osteopathic treatment, yoga classes, mindfulness classes and coaching as well as regular obstetrical care.

We evaluate the psychological status at recruitment, at the end of pregnancy and 40 days after birth.

Full description

The first international scientific research project focusing on a holistic approach to pregnancy is starting now at the Clinica Mangiagalli in Milan.

This innovative model aims to the gold standard of a "positive pregnancy", which supports both the somatic and psychological component of the mother-newborn unit, and thus organically and proactively prevents the main issues arising during pregnancy and delivery due to unhealthy lifestyles.

A team of experts will take comprehensive care of the mother, first by means of an accurate evaluation of her nutritional profile, and then of her biomechanic (osteo-skeletal) state.

Then, the experts will lead an "academic" path, which will initiate a development of her biochemistry (through nutrition), respiration (through yoga), physical wellbeing (through osteopathy and yoga); and strengthen her sense of self, removing her self-doubt (through mindfulness and yoga).

The women will be supported up until childbirth, so as to attempt to prevent the main complications of pregnancy and of delivery.

This model does not aim to substitute the allopathic one which is currently in place (ultrasounds, ob-gyn appointments, tests, etc.), but to enhance its nature in a more effectively THERAPEUTIC manner, increasing the mother-newborn unit's potential of health.

In summary:

• Weekly mindfulness meet-ups
• Weekly yoga meet-ups
• Nutritional screening and further check-ups, if needed
• Osteopathic screening
• Five motivational meetings with a coach
• Four obstetrical appointments
• Obstetrical screening and check-ups up until childbirth

The team in charge of the project is made up of gynaecologists, midwives, psychologists, osteopaths, nutritionists and yoga teachers, who all collaborate on a regular basis with the Clinica Mangiagalli.

The project is offered to women free of charge.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton pregnancies
• spontaneous pregnancies
• no maternal medical conditions
• no language barrier

Exclusion criteria

• maternal or fetal medical conditions
• age <18 or <45
• ivf
• language barrier
• multiple pregnancies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Intervention group

Experimental group

Description:

200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment

Treatment:

Behavioral: Integrated approach to pregnancy

Controls

No Intervention group

Description:

200 woman with single spontaneous pregnancies recieving traditional obstetrical care