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PostpartumESTAQUENCT03521284

Health Education in the Perinatal Period

An observational study of Postpartum, run by Assistance Publique Hopitaux De Marseille.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postpartum
What is being tested?
Parental educational program and Questionnaires
How many people
100 participants
Where
No sites listed yet
Study dates
May 2018to Nov 2019
Phase
Observational
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Young parents in the perinatal and neonatal period

Who may be able to join

  • 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

Who cannot join

  • Patient with newborn child requiring home medical care
  • Patient donnant naissance à un nouveau-né présentant un faible poids à la naissance

Trial locations and contacts

No sites are listed yet.

Véronique BREVAUT MALATY contact

0491968300

veronique.brevaut@ap-hm.fr

Claire MORANDO contact

0491382183

claire.morando@ap-hm.fr

About this study

Official title: 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.

Read more

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.

Conditions
Postpartum
Being tested
Parental educational program, Questionnaires
Keywords
perinatal period

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parental educational programOther

    Behavior: psychotherapy, life hygiene advice

  • QuestionnairesOther

    knowledge questionnaire + parental anxiety questionnaire

Study groups in NCT03521284
Study groupRoleWhat they receive
Mothers with education program during their matNot described
Receives: Other: Parental educational program; Other: Questionnaires
Mothers without education program during their matNot described
Receives: Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the effectiveness of an early parental education program in maternity

    knowledge questionnaires completed by mothers

    Measured: 6 months

Secondary outcomes (1)
  1. Evaluation of the impact of the educational program on maternal anxiety

    questionnaires tested regarding parental anxiety in the perinatal period (STAI-Etat)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study startMay 2018 (estimated)
  3. Primary completionNov 2018 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03521284
Sponsor's protocol ID
2017-60
Acronym
ESTAQUE
Status last verified
Mar 2018
First submitted
2 Mar 2018
Last updated
11 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum, run by Assistance Publique Hopitaux De Marseille.

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 3 inclusion and 2 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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 Véronique BREVAUT MALATY (0491968300, veronique.brevaut@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the effectiveness of an early parental education program in maternity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 May 2018.

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