Motherhood With MOtor Impairment Due to MAlady (Rare Disease)

NCT02727010 | Completed

• 1 other identifier: NI16003
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Disability Evaluation; Child of Impaired Parents

Keywords

Motor disability; Motor impairment; Pregnancy; Parenthood; Child psychology

Outcome Measures

Primary Outcomes (4)

• Child development Mother infant attachment - Coding Interactive Behavior - Pirgas scale - Child protection legal decisions if applicable

  Child development assessed by Brunet Lézine score: based on standardized examination of the infant by a trained child psychologist

  At least once before the age of 14 months. May be repeated twice.

• Infant attachment

  Infant attachment assessed by Guedenet and Fermanian ADBB scale: scale assessed by investigator

  At least once before the age of 14 months. May be repeated twice.

• Social environment

  Social environment assessed by Cutrona scale: self-administered questionnaire

  At least once before the age of 14 months. May be repeated twice.

• Mother infant interaction

  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.

  At least once before the age of 14 months. May be repeated twice.

Secondary Outcomes (10)

• Demographic and social characteristics

  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.

• Disease or event causing impairment

  At lest once before the age of 14 months. May be repeated twice.

• Obstetrical history

  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.

Study Arms (2)

mothers with motor impairment due to a rare disease

20 Women with motor impairment due to a rare disease

mothers with motor impairment not related to a rare disease

controls, 20 women with motor impairment not related to a rare disease

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women or mothers to children \< 14 months, with motor impairment, visiting the inclusion center and willing to participate in the study. Any motor impairment available, regardless of its cause.

You may qualify if:

• 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

You may not qualify if:

• Know mental retardation
• Known psychiatric disorder
• Not fluent in French

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Service d'Aide à la Parentalité des Personnes en Situation de Handicap (SAPPH): collaborator

Study Sites (1)

SAPPH

Paris, 75014, France

Location

Study Officials

• Drina Candilis, PhD

  SAPPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 4, 2016
• Study Start: March 2, 2016
• Primary Completion: August 28, 2017
• Study Completion: November 28, 2017
• Last Updated: May 29, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)