PregnancyMYND&CONCT03839004
MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza
A study testing Integrated approach to pregnancy in people with Pregnancy and Mental Health Wellness 1, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Mental Health Wellness 1
- What is being tested?
- Integrated approach to pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2019to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancies
- spontaneous pregnancies
- no maternal medical conditions
- no language barrier
Who cannot join
- maternal or fetal medical conditions
- age <18 or <45
- ivf
- language barrier
- multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda
Milan, 20122
Clinica Mangiagalli, 02.5503, comunicazione@policlinico.mi.it
About this study
Official title: "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.
Read the 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.
- Conditions
- Pregnancy, Mental Health Wellness 1
- Being tested
- Integrated approach to pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated approach to pregnancyBehavioural
Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment Receives: Behavioral: Integrated approach to pregnancy |
| Controls | No intervention | 200 woman with single spontaneous pregnancies recieving traditional obstetrical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from third month of pregnancy to 1 month after delivery
Woman's physical health during pregnancy
weight gain in pregnancy
Measured: 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
Measured: 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
Measured: 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
Measured: from the 20th week of gestation to 40 days after delivery
Quality of delivery
number of operative deliveries/ cesarean sections
Measured: birth
Newborn's health
apgar
Measured: birth
Newborn's pH
pH at birth
Measured: birth
Newborn's weight
weight at birth
Measured: birth
Newborn's blood gas
blood gas at birth
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start8 Jan 2019
- Primary completionAug 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niccolò Giovannini, MD, Principal investigator, IRCCS Clinica Mangiagalli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839004
- Sponsor's protocol ID
- MYND&CO
- Acronym
- MYND&CO
- Status last verified
- Feb 2019
- First submitted
- 10 Jan 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared
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.
PubMed 34328141
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "MYND&CO: Studio Pilota Sull'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza Secondo Una modalità Multidisciplinare e Personalizzata"
- ClinicalTrials.gov ID
- NCT03839004
- Acronym / sponsor ID
- MYND&CO / MYND&CO
- Conditions
- Pregnancy, Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Integrated approach to pregnancy200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment |
| Controls | No intervention | –200 woman with single spontaneous pregnancies recieving traditional obstetrical care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnancies
- spontaneous pregnancies
- no maternal medical conditions
- no language barrier
Key exclusion criteria (5 listed)
- maternal or fetal medical conditions
- age <18 or <45
- ivf
- language barrier
- multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated approach to pregnancyYoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy | Behavioural | Intervention group |
Primary outcome
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
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
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
Quality of delivery
Time frame: birth
number of operative deliveries/ cesarean sections
Newborn's health
Time frame: birth
apgar
Newborn's pH
Time frame: birth
pH at birth
Newborn's weight
Time frame: birth
weight at birth
Newborn's blood gas
Time frame: birth
blood gas at birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Derived from this study: PubMed 34328141Giovannini 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.
- Individual participant dataSharing planned: No. individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niccolò Giovannini, MD principal investigator
IRCCS Clinica Mangiagalli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated approach to pregnancy in people with Pregnancy and Mental Health Wellness 1, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niccolo' Giovannini, Dr. (00393387026884, niccolo.giovannini@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.