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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Mental Health Wellness 1

Intervention / Treatment
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* Behavioral: Integrated approach to pregnancy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy<br>|
| No Intervention: Controls<br>200 woman with single spontaneous pregnancies recieving traditional obstetrical care | |

What is the study measuring?
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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 |