- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03521284
Health Education in the Perinatal Period (ESTAQUE)
Health Education : Teaching, Support and Questioning of Young Parents in Maternity
Health education is now a major public health issue. In the field of perinatal care, the interests involved are the upgrading of the role of mother / father in the health education of their child and the disengagement of inappropriate pediatric consultations and emergency services in front of mothers who " fail know how to ". A recent review of the literature (Cochrane Library) on the effectiveness of parenting programs in the first 2 months of life of the newborn shows that parental education programs focusing on the explanation of newborn rhythms to young parents increased sleeping time to 6 weeks of life or a significant improvement in the prevention of domestic accidents (checking the water temperature and reducing the risk of burning, sleeping in the bed and preventing unexpected sudden death of the infant, position and respect of instructions during transport by car and prevention of road accidents). However, the authors of this meta-analysis concluded that new studies were needed to confirm the results already published.
The main objective of this study is to evaluate the effectiveness of an early parental education program in maternity both in terms of parental acquisitions and their implementation after leaving the service. These parental acquisitions relate, on the one hand, to the care to be given to the newborn child and, on the other hand, on the possible pathologies that he or she could have, and the best action to be taken by the parents to respond to them. The secondary objective is to evaluate the impact of this program on maternal anxiety in this special period of transition to the role of a parent.
It is a prospective, monocentric, comparative, randomized, controlled, open study. The comparison will be made between two experimental groups. The first experimental group corresponds to the mothers who attended the education program during their maternity stay. The second control group corresponds to mothers who did not attend the training. The primary endpoint for measuring this effectiveness is maternal knowledge assessment using knowledge questionnaires that will be completed by mothers before (pre-test) and after (post-test) the educational program in the maternity unit. The secondary endpoints for assessing the primary objective of measuring this effectiveness are the maternal knowledge assessment 1 month after leaving the maternity, using a questionnaire (Recall-Test) and the assessment of the appeal to a medical consultation for the newborn child in the first month of life and the analysis of the relevance of this recourse to the care. The criterion of evaluation of the secondary objective to measure the impact of the educational program on maternal anxiety will be based on questionnaires tested regarding parental anxiety in the perinatal period (STAI-Etat) before and after the educational program.
The investigators believe that this improvement in parental knowledge will have a positive impact on maternal anxiety in the first month of life and will lead to an improvement in the appropriateness of the use of care during the first month of life. If these results are confirmed, this educational program will have a real medico-economic impact (relieving emergency departments and improving the prognosis of newborns with severe pathologies and taken into care earlier by decreasing in parallel the duration of hospitalization).
The impact of these results will allow to promote more widely the health education in the perinatal and neonatal period by generalizing this educational program in other maternities which could be interested. Also, it will allow to propose this educational program in prenatal (within the framework of session of preparation for the birth), after the release from the service, within the framework of structure of health such as the PMI, the community centers and medical structures, even the distribution of these educational program on a larger scale by means of media such as dedicated web site or smartphone applications.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Véronique BREVAUT MALATY
- Phone Number: 0491968300
- Email: veronique.brevaut@ap-hm.fr
Study Contact Backup
- Name: Claire MORANDO
- Phone Number: 0491382183
- Email: claire.morando@ap-hm.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient giving birth after 37 weeks of amenorrhoea
- Patient giving birth to a newborn child without infectious, malformative or genetic pathology.
- Patient with newborn child hospitalized in Department of Suites de couches, Maternité du pole Femmes-Parents-Enfants, Hopital Nord Marseille
Exclusion Criteria:
- Patient with newborn child requiring home medical care
- Patient donnant naissance à un nouveau-né présentant un faible poids à la naissance
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mothers with education program during their mat
|
Behavior: psychotherapy, life hygiene advice
knowledge questionnaire + parental anxiety questionnaire
|
Mothers without education program during their mat
|
knowledge questionnaire + parental anxiety questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the effectiveness of an early parental education program in maternity
Time Frame: 6 months
|
knowledge questionnaires completed by mothers
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the impact of the educational program on maternal anxiety
Time Frame: 6 months
|
questionnaires tested regarding parental anxiety in the perinatal period (STAI-Etat)
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-60
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
University Hospital, Clermont-FerrandUnknownPostpartum Depression | Postpartum Hemorrhage | Postpartum Women | Postpartum Stress | Postpartum AnxietyFrance
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPostpartumUnited States, Guatemala
-
The Jones InstituteUnknownPostpartum Depressive Mood | Postpartum Sexual FunctionUnited States
-
University of PittsburghAmerican Psychological Foundation; The Pittsburgh FoundationRecruitingPostpartum Depression | Pregnancy Related | Psychological Distress | Postpartum Sadness | Postpartum Anxiety | Postpartum BluesUnited States
-
Cairo UniversityRecruiting
-
London School of Hygiene and Tropical MedicineDepartment for International Development, United Kingdom; Economic and Social... and other collaboratorsCompleted
-
University of North Carolina, Chapel HillSociety of Family PlanningCompletedPostpartum ContraceptionUnited States
-
FHI 360Ghana Health Services; Ministry of Health, ZambiaCompleted
Clinical Trials on Parental educational program
-
Taipei Medical UniversityCompleted
-
University Hospital, MontpellierCompletedInfant DevelopmentFrance
-
Baylor College of MedicineWashington State University; Colorado State UniversityCompletedObesity, ChildhoodUnited States
-
Norwegian University of Science and TechnologyCompletedFecal Incontinence | Staffs' AttitudesNorway
-
Assistance Publique Hopitaux De MarseilleUnknownAutism Spectrum DisorderFrance
-
Universidade Nova de LisboaCompletedAnxiety | Prescription Drug Abuse and DependencyPortugal
-
Medical University of GrazCompleted
-
University of BarcelonaFundació La Marató de TV3; SHE Foundation; Centro Nacional de Investigaciones... and other collaboratorsActive, not recruitingObesity | Diabetes Mellitus | Cardiovascular HealthSpain
-
Universitaire Ziekenhuizen KU LeuvenFund for Scientific Research, Flanders, BelgiumCompletedPain | Breast NeoplasmBelgium
-
Cairo UniversityUnknown