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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Mental Health Wellness 1
• Intervention / Treatment: Behavioral: Integrated approach to pregnancy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niccolo' Giovannini, Dr.; Phone Number: 00393387026884; Email: niccolo.giovannini@policlinico.mi.it
• Study Contact Backup: Name: Giulia Emily Cetera, Dr.; Phone Number: 00393356583395; Email: giuliaemily.cetera@gmail.com

Study Locations

• Italy
  • Milano, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda
    • Contact: Clinica Mangiagalli; Phone Number: 02.5503; Email: comunicazione@policlinico.mi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment	Behavioral: Integrated approach to pregnancy; Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy
No Intervention: Controls; 200 woman with single spontaneous pregnancies recieving traditional obstetrical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Woman's physical health during pregnancy	weight gain in pregnancy	from first trimester of pregnancy to day of delivery
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
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
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
Quality of delivery	number of operative deliveries/ cesarean sections	birth
Newborn's health	apgar	birth
Newborn's pH	pH at birth	birth
Newborn's weight	weight at birth	birth
Newborn's blood gas	blood gas at birth	birth

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Niccolò Giovannini, MD, IRCCS Clinica Mangiagalli

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MYND&CO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No