Premature Birthmother's traumNCT03345641
Emotional Reactions of Mothers Facing Premature Births
An observational study of Premature Birth and Mother's Post-traumatic Reaction, run by CHU de Reims at 1 site in France.
Trial summary
Our intervention in the maternity and neonatal wards helped our sensibility to the immediate parental reaction to the premature birth. Among these reactions, what is called "stress" by the parents occurs most often and is at the origin of trauma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Birth, Mother's Post-traumatic Reaction, Mother-infant Interactions
- What is being tested?
- describe precocious maternal impressions when confronting the premature birth of her infant
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2007to 1 Aug 2011
- 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: Dyads were recruited from maternity or neonatology services.
Who may be able to join
- premature birth (term ≤ to 32 weeks of amenorrhea),
- a mother with niether psychotic troubles- either acute or chronic- nor presenting an addiction (alcohol, narcotic drugs),
- a newborn with no unfavourable vital prognosis, no organic malformation and/or no genetic anomaly diagnosed,
- a mother's age ≥ 18 years,
- a native French speaker.
Who cannot join
- no premature birth (term > to 32 weeks of amenorrhea),
- a mother with psychotic troubles- acute or chronic- presenting an addiction (alcohol, narcotic drugs),
- a newborn with unfavourable vital prognosis, organic malformation and/or genetic anomaly diagnosed,
- a mother's age < 18 years,
- a no native French speaker.
Trial locations and contacts
1 site in 1 country.
About this study
Our intervention in the maternity and neonatal wards helped our sensibility to the immediate parental reaction to the premature birth. Among these reactions, what is called "stress" by the parents occurs most often and is at the origin of trauma. The investigators can cite the unexpected confrontation with a baby is far from corresponding to what the parents had anticipated; the stunned feeling while experiencing a chain of events rapidly taking place, an experience of emptiness when the baby is placed in the intensive care unit, the feeling of powerlessness when facing the real risk of the infant's death, the striking spectacle of invasive treatments, etc. The parents worry about the viability and future of their premature infant. Their parental impressions and more specifically those of the mother facing the premature birth could in and of themselves have repercussions on the development of the infant, by betting on a complex meeting and atypical interactions.
These observations have driven us to elaborate on a hypothesis that finds itself separate from the lesion model commonly applied to premature infants, and shifts the psychopathological approach to the post-traumatic reaction of the mother following the premature birth and repositions the question of behavioral disorders of the child in the interaction mother-infant field. The investigators think that the premature birth can bring about in a second phase and notably in the mother, post-traumatic symptoms as described in the post-traumatic stress state, and that this reaction could have effects on the mother-infant interactions. The investigators have carried out the current study to clarify the relationship between the mother's post-traumatic reaction triggered by the premature birth and the mother-infant interactions.
Read the detailed description
2.1 Design A multicenter prospective study was performed in three French hospitals (Reims, Nancy and Besançon) between January 2008 and January 2011. The follow-up period was 18 months for each dyad.
2.2 Population
In practice, our study will be carried out in five sessions and at three visits:
The first visit in maternity service, following the birth of the child, the second visit, in the neonatology service, right before the discharge. The third time will be repeated at 6, 12 and 18 months, within the framework of the systematic tracking of premature babies within the early medico-social actions' center (CAMSP).
2.3 Data collection 2.3.1 Sociodemographic and clinical data Sociodemographic variables recorded during the study were age, marital status, level of education and profession.
For the mothers, clinical data were: number of childbirths, number of pregnancies, medical history of the pregnancy (threatened premature labor, hospitalization,...), obstetric history (miscarriage, medical interruption of pregnancy, termination of pregnancy, in vitro fertilization, threatened premature labor, prematurity, hospitalizations,…), delivery conditions (C-section or vaginal), multiple pregnancy (number of babies), anesthesia type (none, epidural, total), personal histories (medical, surgical, psychiatric, family).
For the infants, clinical data were: date of birth, term of birth, weight, size, cranial perimeter, Apgar score at five and ten minutes, necessity or not of a neonatal resuscitation, method of feeding (breast-, bottle-, mixed-feeding).
For the dyads, clinical data were the presence or absence of a specific coping (psychologist, psychomotor therapist, …).
2.3.2 Evaluation scales 2.3.2.1 For the mother Evaluation of trauma of the mother using " Perinatal Posttraumatic Stress Disorder " or PPQ.
It consists of a self--questionnaire made up of 14 items, specially adapted to the parents of perinatal high-risk children, in order to evaluate the presence of traumatic elements concerning the birth.
In order to neutralize identified biases, the investigators also evaluate the maternal co morbidity while using:
The HADS scale (Hospital Anxiety and Depression Scale) which is a self-questionnaire frequently used in international literature. Fast and easy to use, it makes it possible to evaluate anxious and depressive symptomatology of the people having somatic diseases. It makes it possible to evaluate the episodes of recent anxiety and depression and to attribute an overall score to each one. The result is expressed in a score.
The EPDS scale (Edinburgh Post-natal Depression Scale) consists of a self-questionnaire that tracks postnatal depression and includes 10 items, which the investigators offer to the mother as of the 4th week of postpartum.
The maternal social support self-evaluation by the Support Social Questionnaire (SSQ) of Sarason, proposes the measure of the number of people available and the perceived quality of this support, using 6 items.
2.3.2.2 For the child The investigators evaluate the perinatal risk of the infant with the scale Perinatal Risk Inventory (PRI). This scale uses 18 items to describe the gravity of the perinatal problems and the severity of the perinatal risk while being based on perinatal factors such as the Apgar score, the gestational age, the weight or the cranial perimeter.
The developmental evaluation of the child is done using DDST, Denver Developmental Screening Test. This assessment makes it possible to evaluate the level of the child between 0 to 6 years of age in the various fields of the development (global motricity, language, fine motricity, social contact).
The perceived temperament of the child is evaluated by the self-questionnaire filled out by the mother on the temperament of her infant QT6, translation of Bates' "Infant Characteristics Questionnaire". The mother ranks each item indicating the level of perceived difficulty in dealing with the described behavior. Four subscales have been identified through principal components analyses: Fussy/Difficult, Unadaptable, Dull, and Unpredictable.
2.3.2.3 For the interactions in the dyad Censullo's DMC (Dyadic Mutuality Code) Scale can be used for the first 6 months of the baby's life. After a 5-minute observation of the dyad interacting the observer codes 6 items (mutual attention, positive affect, reciprocity, maternal pauses, clearness of the signals of the baby, receptivity/maternal sensitivity). The score makes it possible to define a low or high interactional synchrony.
Fiese's PIPE (Pediatric Infant Parent Exam) can be used from 0 to 18 months. The mother is invited to play for a short time, games like "peek-a-boo" with her baby. The observer of the interaction grants a grade to the degree of interactional reciprocity and positive affects at the beginning, during and at the end of the play.
- Being tested
- describe precocious maternal impressions when confronting the premature birth of her infant
- Keywords
- premature birth, mother's post-traumatic reaction, mother-infant interactions
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
describe precocious maternal impressions when confronting the premature birth of her infantOther
| Study group | Role | What they receive |
|---|---|---|
| dyads | dyads with babies and their mothers Receives: Other: describe precocious maternal impressions when confronting the premature birth of her infant |
What is being measured
The primary outcome is the main question the study is designed to answer.
mother's post-traumatic reaction
relationship between the mother's post-traumatic reaction triggered by the premature birth (PPQ: Perinatal PostTraumatic Stress Disorder) and the mother-infant interactions (DMC : Dyadic Mutuality Code)
Measured: Month 6
Secondary outcomes (11)
relationship between the post-traumatic response of the mother in the perinatal period (PPQ: Perinatal PostTraumatic Stress Disorder) and that which is always evaluated in the mother
Measured: Month 6
relationship between perinatal risk (PRI : Perinatal Risk Inventory) and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Measured: Month 6
relationship between pediatric assessment of the child and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Measured: Month 6
mother's post-traumatic reaction
relationship between the mother's post-traumatic reaction triggered by the premature birth (PPQ: Perinatal PostTraumatic Stress Disorder) and the mother-infant interactions (PIPE : Pediatric Infant Parent Exam)
Measured: Month 12
relationship between the post-traumatic response of the mother in the perinatal period (PPQ: Perinatal PostTraumatic Stress Disorder) and that which is always evaluated in the mother
Measured: Month 12
relationship between perinatal risk (PRI : Perinatal Risk Inventory) and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Measured: Month 12
relationship between pediatric assessment of the child and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Measured: Month 12
mother's post-traumatic reaction
relationship between the mother's post-traumatic reaction triggered by the premature birth (PPQ: Perinatal PostTraumatic Stress Disorder) and the mother-infant interactions (PIPE :Pediatric Infant Parent Exam)
Measured: Month 18
relationship between the post-traumatic response of the mother in the perinatal period (PPQ: Perinatal PostTraumatic Stress Disorder) and that which is always evaluated in the mother
Measured: Month 18
relationship between perinatal risk (PRI : Perinatal Risk Inventory) and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Measured: Month 18
relationship between pediatric assessment of the child and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2007
- Primary completion1 Dec 2010
- Study completion1 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345641
- Sponsor's protocol ID
- PR06002
- Acronym
- mother's traum
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Reactions of Mothers Facing Premature Births
- ClinicalTrials.gov ID
- NCT03345641
- Acronym / sponsor ID
- mother's traum / PR06002
- Keywords
- premature birth, mother's post-traumatic reaction, mother-infant interactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 1 Aug 2011 (actual)
- First posted
- 17 Nov 2017 (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.
Our intervention in the maternity and neonatal wards helped our sensibility to the immediate parental reaction to the premature birth. Among these reactions, what is called "stress" by the parents occurs most often and is at the origin of trauma. The investigators can cite the unexpected confrontation with a baby is far from corresponding to what the parents had anticipated; the stunned feeling while experiencing a chain of events rapidly taking place, an experience of emptiness when the baby is placed in the intensive care unit, the feeling of powerlessness when facing the real risk of the infant's death, the striking spectacle of invasive treatments, etc. The parents worry about the viability and future of their premature infant. Their parental impressions and more specifically those of the mother facing the premature birth could in and of themselves have repercussions on the development of the infant, by betting on a complex meeting and atypical interactions.
These observations have driven us to elaborate on a hypothesis that finds itself separate from the lesion model commonly applied to premature infants, and shifts the psychopathological approach to the post-traumatic reaction of the mother following the premature birth and repositions the question of behavioral disorders of the child in the interaction mother-infant field. The investigators think that the premature birth can bring about in a second phase and notably in the mother, post-traumatic symptoms as described in the post-traumatic stress state, and that this reaction could have effects on the mother-infant interactions. The investigators have carried out the current study to clarify the relationship between the mother's post-traumatic reaction triggered by the premature birth and the mother-infant interactions.
Detailed description
2.1 Design A multicenter prospective study was performed in three French hospitals (Reims, Nancy and Besançon) between January 2008 and January 2011. The follow-up period was 18 months for each dyad.
2.2 Population
In practice, our study will be carried out in five sessions and at three visits:
The first visit in maternity service, following the birth of the child, the second visit, in the neonatology service, right before the discharge. The third time will be repeated at 6, 12 and 18 months, within the framework of the systematic tracking of premature babies within the early medico-social actions' center (CAMSP).
2.3 Data collection 2.3.1 Sociodemographic and clinical data Sociodemographic variables recorded during the study were age, marital status, level of education and profession.
For the mothers, clinical data were: number of childbirths, number of pregnancies, medical history of the pregnancy (threatened premature labor, hospitalization,...), obstetric history (miscarriage, medical interruption of pregnancy, termination of pregnancy, in vitro fertilization, threatened premature labor, prematurity, hospitalizations,…), delivery conditions (C-section or vaginal), multiple pregnancy (number of babies), anesthesia type (none, epidural, total), personal histories (medical, surgical, psychiatric, family).
For the infants, clinical data were: date of birth, term of birth, weight, size, cranial perimeter, Apgar score at five and ten minutes, necessity or not of a neonatal resuscitation, method of feeding (breast-, bottle-, mixed-feeding).
For the dyads, clinical data were the presence or absence of a specific coping (psychologist, psychomotor therapist, …).
2.3.2 Evaluation scales 2.3.2.1 For the mother Evaluation of trauma of the mother using " Perinatal Posttraumatic Stress Disorder " or PPQ.
It consists of a self--questionnaire made up of 14 items, specially adapted to the parents of perinatal high-risk children, in order to evaluate the presence of traumatic elements concerning the birth.
In order to neutralize identified biases, the investigators also evaluate the maternal co morbidity while using:
The HADS scale (Hospital Anxiety and Depression Scale) which is a self-questionnaire frequently used in international literature. Fast and easy to use, it makes it possible to evaluate anxious and depressive symptomatology of the people having somatic diseases. It makes it possible to evaluate the episodes of recent anxiety and depression and to attribute an overall score to each one. The result is expressed in a score.
The EPDS scale (Edinburgh Post-natal Depression Scale) consists of a self-questionnaire that tracks postnatal depression and includes 10 items, which the investigators offer to the mother as of the 4th week of postpartum.
The maternal social support self-evaluation by the Support Social Questionnaire (SSQ) of Sarason, proposes the measure of the number of people available and the perceived quality of this support, using 6 items.
2.3.2.2 For the child The investigators evaluate the perinatal risk of the infant with the scale Perinatal Risk Inventory (PRI). This scale uses 18 items to describe the gravity of the perinatal problems and the severity of the perinatal risk while being based on perinatal factors such as the Apgar score, the gestational age, the weight or the cranial perimeter.
The developmental evaluation of the child is done using DDST, Denver Developmental Screening Test. This assessment makes it possible to evaluate the level of the child between 0 to 6 years of age in the various fields of the development (global motricity, language, fine motricity, social contact).
The perceived temperament of the child is evaluated by the self-questionnaire filled out by the mother on the temperament of her infant QT6, translation of Bates' "Infant Characteristics Questionnaire". The mother ranks each item indicating the level of perceived difficulty in dealing with the described behavior. Four subscales have been identified through principal components analyses: Fussy/Difficult, Unadaptable, Dull, and Unpredictable.
2.3.2.3 For the interactions in the dyad Censullo's DMC (Dyadic Mutuality Code) Scale can be used for the first 6 months of the baby's life. After a 5-minute observation of the dyad interacting the observer codes 6 items (mutual attention, positive affect, reciprocity, maternal pauses, clearness of the signals of the baby, receptivity/maternal sensitivity). The score makes it possible to define a low or high interactional synchrony.
Fiese's PIPE (Pediatric Infant Parent Exam) can be used from 0 to 18 months. The mother is invited to play for a short time, games like "peek-a-boo" with her baby. The observer of the interaction grants a grade to the degree of interactional reciprocity and positive affects at the beginning, during and at the end of the play.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dyads | – | Other: describe precocious maternal impressions when confronting the premature birth of her infantdyads with babies and their mothers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dyads were recruited from maternity or neonatology services.
Key inclusion criteria (5 listed)
- premature birth (term ≤ to 32 weeks of amenorrhea),
- a mother with niether psychotic troubles- either acute or chronic- nor presenting an addiction (alcohol, narcotic drugs),
- a newborn with no unfavourable vital prognosis, no organic malformation and/or no genetic anomaly diagnosed,
- a mother's age ≥ 18 years,
- a native French speaker.
Key exclusion criteria (5 listed)
- no premature birth (term > to 32 weeks of amenorrhea),
- a mother with psychotic troubles- acute or chronic- presenting an addiction (alcohol, narcotic drugs),
- a newborn with unfavourable vital prognosis, organic malformation and/or genetic anomaly diagnosed,
- a mother's age < 18 years,
- a no native French speaker.
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 |
|---|---|---|
| describe precocious maternal impressions when confronting the premature birth of her infant | Other | dyads |
Primary outcome
mother's post-traumatic reaction
Time frame: Month 6
relationship between the mother's post-traumatic reaction triggered by the premature birth (PPQ: Perinatal PostTraumatic Stress Disorder) and the mother-infant interactions (DMC : Dyadic Mutuality Code)
11 secondary outcomes
relationship between the post-traumatic response of the mother in the perinatal period (PPQ: Perinatal PostTraumatic Stress Disorder) and that which is always evaluated in the mother
Time frame: Month 6
relationship between perinatal risk (PRI : Perinatal Risk Inventory) and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Time frame: Month 6
relationship between pediatric assessment of the child and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Time frame: Month 6
mother's post-traumatic reaction
Time frame: Month 12
relationship between the post-traumatic response of the mother in the perinatal period (PPQ: Perinatal PostTraumatic Stress Disorder) and that which is always evaluated in the mother
Time frame: Month 12
relationship between perinatal risk (PRI : Perinatal Risk Inventory) and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Time frame: Month 12
relationship between pediatric assessment of the child and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Time frame: Month 12
mother's post-traumatic reaction
Time frame: Month 18
relationship between the post-traumatic response of the mother in the perinatal period (PPQ: Perinatal PostTraumatic Stress Disorder) and that which is always evaluated in the mother
Time frame: Month 18
relationship between perinatal risk (PRI : Perinatal Risk Inventory) and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Time frame: Month 18
relationship between pediatric assessment of the child and trauma (PPQ: Perinatal PostTraumatic Stress Disorder)
Time frame: Month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Mother's Post-traumatic Reaction, run by CHU de Reims at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 17 Nov 2017. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mother's post-traumatic reaction (time frame: Month 6). 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 17 Nov 2017.