Clinical Trial: Motherhood With MOtor Impairment Due to MAlady (Rare Disease)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Parenthood and Motherhood in Women With Motor Impairment and Disability Related to a Rare Disease

Brief Summary:

Background Women with rare diseases resulting in motor disabilities wishing to become mother face a major challenge. The investigators hypothesize that provided with adequate support, they are able to achieve a successful pregnancy and to offer their child a safe family environment.

Methods To test this hypothesis, the investigators shall conduct a prospective observational prospective survey of a consecutive series of volunteer pregnant women or mothers of children less than 14 months, with motor impairment, participating in a program of parenting support developed in our institution.

Primary outcome: social environment, child development, mother-infant attachment, mother- infant interactions Secondary outcome: social and demographic characteristics, severity of motor impairment, associated impairment, perinatal morbidity for the mother and the infant (composite indicator), emotional status, and the needs expressed by women regarding the level of medical or social care.

Analysis The investigators shall describe the distribution of the primary outcome measurements in the subgroup of women with motor impairment related to a rare disease. The investigators shall compare this distribution to the expected distribution in the general population, and to that observed in women with motor impairment unrelated to a rare disease. The investigators shall also study primary outcome measurements as a function of the severity of maternal disability, of the mother's social characteristics and emotional status.

The investigators shall also describe the distribution the distribution of perinatal morbidity globally, and as a function of the potential explanatory variables mentioned above.

The

Detailed Summary:

Background Women with motor disabilities have the same well-founded desire to become a mother as other women. Despite dedicated aids and adapted supportive measures, they face social blame from persons who believe they are not apt to provide adequate care to their children. When a rare disease caused the disability, planning to become a mother is even more critical, since most perinatal care providers are unfamiliar with the condition, and specialists of the disease are unfamiliar with pregnancy. Unsurprisingly, data on motherhood in women with rare diseases resulting in motor impairment are scarce.

The institutions of the investigators run a joint care program dedicated to future parents and parents with disabilities, namely:

• Hôpital Universitaire Pitié Salpêtrière- Charles Foix (assistance Publique Hôpitaux de Paris and Université Paris 6), providing a gynecological and perinatal unit with care programs adapted to women with disabilities, plus a number of reference centers for rare neurologic and muscular diseases including research and clinical care.
• Service d'Aide à la Parentalité des Personnes en Situation de Handicap (SAPPH, Fondation Hospitalière Sainte Marie) providing training and support to parenthood to persons with motor or sensory disabilities. This training program aims at recognizing parental capacities, and if necessary enhancing them by information, training, adapting the environment, or seeking extra human help.

The investigators felt the need to evaluate the outcome of our program, in terms of quality of infant environment, development, attachment, and interactions with their disabled mother. The investigators focused on parenthood in wom
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome:

• Child development Mother infant attachment - Coding Interactive Behavior - Pirgas scale - Child protection legal decisions if applicable [ Time Frame: At least once before the age of 14 months. May be repeated twice. ]
  Child development assessed by Brunet Lézine score: based on standardized examination of the infant by a trained child psychologist
• Infant attachment [ Time Frame: At least once before the age of 14 months. May be repeated twice. ]
  Infant attachment assessed by Guedenet and Fermanian ADBB scale: scale assessed by investigator
• Social environment [ Time Frame: At least once before the age of 14 months. May be repeated twice. ]
  Social environment assessed by Cutrona scale: self-administered questionnaire
• Mother infant interaction [ Time Frame: At least once before the age of 14 months. May be repeated twice. ]

  assessed by:

  • Coding Interactive Behavior: mother infant interaction filmed in a standardized fashion, and analyzed by trained psychologists blinded to the dyad's history.
  • Pirgas scale: clinical diagnosis regarding mother to infant interactions Child protection legal decisions : type of decision if applicable.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Demographic and social characteristics [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  Demographic and social characteristics, qualitative variables (Questionnaire administered by investigator)
• Epices score of social deprivation [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  Epices score of social deprivation (Self-administered questionnaire)
• Disease or event causing impairment [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  Disease or event causing impairment: preset qualitative variables (Questionnaire administered by investigator)
• Obstetrical history [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  Obstetrical history: preset qualitative variables (Questionnaire administered by investigator)
• Somatic and psychic events before, during pregnancy, and post-partum (composite scores) [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
• History of access to care [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  History of access to care: standardized interview (Questionnaire administered by investigator)
• Barthel score of capacity in everyday life [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  Barthel score of capacity in everyday life (Self-administered questionnaire)
• Ad hoc ordinal score based on the number of body parts with motor impairment and additional non-motor impairment [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
• Maternal emotional status [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  Assessed by STAI / EPDS scales (Self-administered questionnaire)
• List of the needs expressed by women regarding medical care, psychological, social, and environmental support [ Time Frame: At lest once before the age of 14 months. May be repeated twice. ]
  Assessed self-administered questionnaire

Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 29, 2016
Date Started: November 2016
Date Completion: June 2019
Last Updated: December 12, 2016
Last Verified: December 2016