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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03839004
Study type	Interventional
Source	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact	Niccolo' Giovannini, Dr.
Phone	00393387026884
Email	niccolo.giovannini@policlinico.mi.it
Status	Recruiting
Phase	N/A
Start date	January 8, 2019
Completion date	January 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms