PostpartumESTAQUENCT03521284
Health Education in the Perinatal Period
An observational study of Postpartum, run by Assistance Publique Hopitaux De Marseille.
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.
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 group | Role | What they receive |
|---|---|---|
| Mothers with education program during their mat | Not described Receives: Other: Parental educational program; Other: Questionnaires | |
| Mothers without education program during their mat | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effectiveness of an early parental education program in maternity
knowledge questionnaires completed by mothers
Measured: 6 months
Secondary outcomes (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.
- First posted11 May 2018
- Study startMay 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hopitaux De Marseille
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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education : Teaching, Support and Questioning of Young Parents in Maternity
- ClinicalTrials.gov ID
- NCT03521284
- Acronym / sponsor ID
- ESTAQUE / 2017-60
- Conditions
- Postpartum
- Keywords
- perinatal period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 11 May 2018 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers with education program during their mat | – | Other: Parental educational program, Other: Questionnaires |
| Mothers without education program during their mat | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Young parents in the perinatal and neonatal period
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient with newborn child requiring home medical care
- Patient donnant naissance à un nouveau-né présentant un faible poids à la naissance
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 |
|---|---|---|
| Parental educational programBehavior: psychotherapy, life hygiene advice | Other | Mothers with education program during their mat |
| Questionnairesknowledge questionnaire + parental anxiety questionnaire | Other | Mothers with education program during their mat, Mothers without education program during their mat |
Primary outcome
Evaluation of the effectiveness of an early parental education program in maternity
Time frame: 6 months
knowledge questionnaires completed by mothers
1 secondary outcome
Evaluation of the impact of the educational program on maternal anxiety
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
Urielle DESALBRES study director
Assistance Publique Hopitaux De Marseille
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.