Clinical trial NCT01566058: Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships
Official title: Pilot Study Evaluating the Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and the Establishment of a Mother-child Relationship in the Context of a Premature Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Anxiety
Keywords: Post partum
mother-child relationships
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.

Detailed description: The secondary objectives of the study are to compare the following between the two arms of the study:

A. The degree of postpartum maternal anxiety at day 1, day 7 and at hospital discharge. Anxiety will be compared point by point but also via kinetics.

B. The incidence maternal post traumatic stress disorder at 6 and 12 months.

C. The incidence of mother-child relationship disorders at 6 and 12 months.

D. Infant vital signs during the hospital stay.

Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow up
* The patient has given birth this day to a premature child (\< 36 weeks of gestation and/or \< 2 kg birthweight)
* Separation of child and mother since birth

Exclusion Criteria:

* The patient or baby is participating in another study, excepting the studies "OASIS" or "PROM8736"
* The patient or baby is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient or father refuses to sign the consent
* It is impossible to correctly inform the patient
* Preexisting maternal psychiatric pathology
* Major or lethal poly-malformation syndrome
* Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain
* Any emergency situation preventing patient involvement
* Mother and/or child not hospitalized at the Nîmes University Hospital
* Death of the patient or child during the study

Primary outcomes:
measure: Questionnaire HADS
timeFrame: Day 3 post-partum
Secondary outcomes:
measure: Questionnaire HADS
timeFrame: baseline; day 0
measure: Questionnaire HADS
timeFrame: Day 1 post partum
measure: Questionnaire HADS
timeFrame: Day 7 post partum
measure: Questionnaire HADS
timeFrame: Day of hospital discharge for the baby (expected average of 4 weeks)
measure: Questionnaire PPQ (post traumatic stress disorder)
timeFrame: 6 months post partum
measure: Questionnaire PPQ (post traumatic stress disorder)
timeFrame: 12 months post partum
measure: Massie Campbell scale for mother-child relationships
timeFrame: Day of hospital discharge for the baby (expected average of 4 weeks)
measure: Massie Campbell scale for mother-child relationships
timeFrame: 6 months post partum
measure: Massie Campbell scale for mother-child relationships
timeFrame: 12 months post partum
measure: Number of infant cardiovascular events
timeFrame: base line to day of hospital discharge for the baby (expected average of 4 weeks)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Fernando Benito-Castro, MD
role: PRINCIPAL_INVESTIGATOR
References: