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Completed

NCT Number: NCT01566058

Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BB Box available

Device

The BB Box video system is provided to the mother during the hospitalisation of her premature baby.

No BB Box

Other

The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.

Other names: Standard care

Primary outcomes

  1. Questionnaire HADS

    Time frame: Day 3 post-partum

    Score ranging from 0 - 21

Secondary outcomes

  1. Questionnaire HADS

    Time frame: baseline; day 0

    score ranging from 0 to 21

  2. Questionnaire HADS

    Time frame: Day 1 post partum

    score ranging from 0 to 21

  3. Questionnaire HADS

    Time frame: Day 7 post partum

    score ranging from 0 to 21

  4. Questionnaire HADS

    Time frame: Day of hospital discharge for the baby (expected average of 4 weeks)

    score ranging from 0 to 21

  5. Questionnaire PPQ (post traumatic stress disorder)

    Time frame: 6 months post partum

    score ranging from 0 to 14

  6. Questionnaire PPQ (post traumatic stress disorder)

    Time frame: 12 months post partum

    score ranging from 0 to 14

  7. Massie Campbell scale for mother-child relationships

    Time frame: Day of hospital discharge for the baby (expected average of 4 weeks)

  8. Massie Campbell scale for mother-child relationships

    Time frame: 6 months post partum

  9. Massie Campbell scale for mother-child relationships

    Time frame: 12 months post partum

  10. Number of infant cardiovascular events

    Time frame: base line to day of hospital discharge for the baby (expected average of 4 weeks)

    includes bradycardia < 100/min and O2 saturation < 60%

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: BBBox

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 29, 2012
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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