"MYND&CO: Studio Pilota Sull'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza Secondo Una modalità Multidisciplinare e Personalizzata"
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Quality of delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •singleton pregnancies
- •spontaneous pregnancies
- •no maternal medical conditions
- •no language barrier
Exclusion Criteria
- •maternal or fetal medical conditions
- •age <18 or <45
- •language barrier
- •multiple pregnancies
Arms & Interventions
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
Intervention: Integrated approach to pregnancy (Behavioral)
Controls
200 woman with single spontaneous pregnancies recieving traditional obstetrical care
Outcomes
Primary Outcomes
Quality of delivery
Time Frame: birth
number of operative deliveries/ cesarean sections
Newborn's weight
Time Frame: birth
weight at birth
Woman's physical health during pregnancy
Time Frame: from first trimester of pregnancy to day of delivery
weight gain in pregnancy
Diagnosis of pregnancy-related diabetes
Time Frame: from 24 weeks of pregnancy to the day of delivery
positive blood glucose curve or fasting glucose \>92 on 2 different measurements
Newborn's pH
Time Frame: birth
pH at birth
Evolution in women's mental health from t0( first trimester) to after birth (40 days after delivery)
Time Frame: from third month of pregnancy to 1 month after delivery
evaluated by the means of psychological questionaire SF12
Newborn's blood gas
Time Frame: birth
blood gas at birth
Diagnosis of pregnancy-related hypertension
Time Frame: 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
Time Frame: 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
Time Frame: birth
apgar
Secondary Outcomes
No secondary outcomes reported