MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza
- Conditions
- Mental Health Wellness 1Pregnancy
- Interventions
- Behavioral: Integrated approach to pregnancy
- Registration Number
- NCT03839004
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 400
- singleton pregnancies
- spontaneous pregnancies
- no maternal medical conditions
- no language barrier
- maternal or fetal medical conditions
- age <18 or <45
- ivf
- language barrier
- multiple pregnancies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention group Integrated approach to pregnancy 200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment
- Primary Outcome Measures
Name Time Method Quality of delivery birth number of operative deliveries/ cesarean sections
Newborn's pH birth pH at birth
Woman's physical health during pregnancy from first trimester of pregnancy to day of delivery weight gain in pregnancy
Diagnosis of pregnancy-related diabetes from 24 weeks of pregnancy to the day of delivery positive blood glucose curve or fasting glucose \>92 on 2 different measurements
Newborn's weight birth weight at birth
Evolution in women's mental health from t0( first trimester) to after birth (40 days after delivery) from third month of pregnancy to 1 month after delivery evaluated by the means of psychological questionaire SF12
Newborn's blood gas birth blood gas at birth
Diagnosis of pregnancy-related hypertension from the 20th week of gestation to 40 days after delivery diagnosis of hypertension from the 20th week of gestation to 40 days after delivery
Woman's osteo-muscular health during pregnancy from the 20th week of gestation to 40 days after delivery diagnosis of low back pain and sciatic nerve pain during pregnancy
Newborn's health birth apgar
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione IRCCS Ca' Granda
🇮🇹Milano, Italy