Parenthood and Motherhood in Women With Motor Impairment and Disability Related to a Rare Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Mother infant interaction
研究概览
简要总结
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 investigators shall also report on the opinion of women regarding the support they were offered so far, and the support they declare they should benefit from.
详细描述
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 women with a rare disease resulting in motor impairment, a research field remaining largely unexplored so far.
Hypothesis Our hypothesis is that when provided with a specific care program, mothers with motor impairment due to a rare disease and their partners have the capacity to offer their children appropriate social environment and care, resulting in child development, mother-infant attachment, and mother- infant interactions being similar to what one would expect in women without motor impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 or older
- •Either pregnant > 14 weeks, or mother of a child < 1 year
- •With disability resulting from motor impairment
- •Giving informed consent
- •With social insurance
排除标准
- •Know mental retardation
- •Known psychiatric disorder
- •Not fluent in French
结局指标
主要结局
Mother infant interaction
时间窗: 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.
Infant attachment
时间窗: 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
时间窗: At least once before the age of 14 months. May be repeated twice.
Social environment assessed by Cutrona scale: self-administered questionnaire
Child development Mother infant attachment - Coding Interactive Behavior - Pirgas scale - Child protection legal decisions if applicable
时间窗: 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
次要结局
- Obstetrical history(At lest once before the age of 14 months. May be repeated twice.)
- Demographic and social characteristics(At lest once before the age of 14 months. May be repeated twice.)
- Somatic and psychic events before, during pregnancy, and post-partum (composite scores)(At lest once before the age of 14 months. May be repeated twice.)
- History of access to care(At lest once before the age of 14 months. May be repeated twice.)
- Disease or event causing impairment(At lest once before the age of 14 months. May be repeated twice.)
- Ad hoc ordinal score based on the number of body parts with motor impairment and additional non-motor impairment(At lest once before the age of 14 months. May be repeated twice.)
- Epices score of social deprivation(At lest once before the age of 14 months. May be repeated twice.)
- List of the needs expressed by women regarding medical care, psychological, social, and environmental support(At lest once before the age of 14 months. May be repeated twice.)
- Barthel score of capacity in everyday life(At lest once before the age of 14 months. May be repeated twice.)
- Maternal emotional status(At lest once before the age of 14 months. May be repeated twice.)