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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

January 10, 2019

Last Update Submit

February 11, 2019

Conditions

PregnancyMental Health Wellness 1

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (2)

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

Behavioral: Integrated approach to pregnancy

Controls

NO INTERVENTION

200 woman with single spontaneous pregnancies recieving traditional obstetrical care

Interventions

Integrated approach to pregnancyBEHAVIORAL

Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancies
  • spontaneous pregnancies
  • no maternal medical conditions
  • no language barrier

You may not qualify if:

  • maternal or fetal medical conditions
  • age \<18 or \<45
  • ivf
  • language barrier
  • multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda

Milan, 20122, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34328141DERIVED

Study Officials

  • Niccolò Giovannini, MD

    IRCCS Clinica Mangiagalli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niccolo' Giovannini, Dr.

CONTACT

00393387026884niccolo.giovannini@policlinico.mi.it

Giulia Emily Cetera, Dr.

CONTACT

00393356583395giuliaemily.cetera@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

February 12, 2019

Study Start

January 8, 2019

Primary Completion

August 1, 2020

Study Completion

January 1, 2021

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

individual participant data will not be shared

Locations

IT(1)