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

Pregnancy Clinical Trial

— MYND&CO  

Official title:

"MYND&CO: Studio Pilota Sull'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza Secondo Una modalità Multidisciplinare e Personalizzata"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839004
• Other study ID #: MYND&CO
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: January 2021

Study information

• Verified date: February 2019
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Niccolo' Giovannini, Dr.
• Phone: 00393387026884
• Email: niccolo.giovannini[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1
• Pregnancy

Intervention

Behavioral:
• Integrated approach to pregnancy
Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution in women's mental health from t0( first trimester) to after birth (40 days after delivery)	evaluated by the means of psychological questionaire SF12	from third month of pregnancy to 1 month after delivery
Primary	Woman's physical health during pregnancy	weight gain in pregnancy	from first trimester of pregnancy to day of delivery
Primary	Diagnosis of pregnancy-related diabetes	positive blood glucose curve or fasting glucose >92 on 2 different measurements	from 24 weeks of pregnancy to the day of delivery
Primary	Diagnosis of pregnancy-related hypertension	diagnosis of hypertension from the 20th week of gestation to 40 days after delivery	from the 20th week of gestation to 40 days after delivery
Primary	Woman's osteo-muscular health during pregnancy	diagnosis of low back pain and sciatic nerve pain during pregnancy	from the 20th week of gestation to 40 days after delivery
Primary	Quality of delivery	number of operative deliveries/ cesarean sections	birth
Primary	Newborn's health	apgar	birth
Primary	Newborn's pH	pH at birth	birth
Primary	Newborn's weight	weight at birth	birth
Primary	Newborn's blood gas	blood gas at birth	birth