Clinical trial NCT03839004: MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza
Official title: "MYND&CO: Studio Pilota Sull'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza Secondo Una modalità Multidisciplinare e Personalizzata"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Mental Health Wellness 1
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution in women's mental health from t0( first trimester) to after birth (40 days after delivery)
timeFrame: from third month of pregnancy to 1 month after delivery
measure: Woman's physical health during pregnancy
timeFrame: from first trimester of pregnancy to day of delivery
measure: Diagnosis of pregnancy-related diabetes
timeFrame: from 24 weeks of pregnancy to the day of delivery
measure: Diagnosis of pregnancy-related hypertension
timeFrame: from the 20th week of gestation to 40 days after delivery
measure: Woman's osteo-muscular health during pregnancy
timeFrame: from the 20th week of gestation to 40 days after delivery
measure: Quality of delivery
timeFrame: birth
measure: Newborn's health
timeFrame: birth
measure: Newborn's pH
timeFrame: birth
measure: Newborn's weight
timeFrame: birth
measure: Newborn's blood gas
timeFrame: birth
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda
Study officials:
affiliation: IRCCS Clinica Mangiagalli
name: Niccolò Giovannini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giovannini N, Cetera GE, Ercolino C, Miozzo MR, Parazzini F, Ferrazzi EM, Manzotti A, Colaceci S. MYNd&CO (Mindfulness, Yoga, Nutrition, development & Coaching, and Osteopathy) randomized controlled trial for a positive psychophysical experience in pregnancy and after birth: a study protocol. Acta Biomed. 2021 Jul 29;92(S2):e2021032. doi: 10.23750/abm.v92iS2.11259.