Clinical trial NCT03072303: Pregnancy in Osteogenesis Imperfecta (OI) Registry
Official title: Pregnancy in Osteogenesis Imperfecta (OI) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteogenesis Imperfecta
Brittle Bone Disorders
Keywords: Brittle Bone
Osteogenesis Imperfecta
BBD
OI
Congenital Abnormalities
Congenital Bone Disorder
Lobstein Syndrome
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Rare Diseases Clinical Research Network
name: National Institutes of Health (NIH)
First posted: 2017-03-07
Enrollment: 170
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The RDCRN BBD Contact Registry helps researchers identify and recruit patients who are eligible for participation in future research studies. People eligible for enrollment in the RDCRN BBD Contact Registry include patients and parents of patients with Brittle Bone Disorders. All patients with BBD from the United States and around the world are encouraged to join.

Brief summary: The purpose of this study is to learn about pregnancy outcomes in osteogenesis imperfecta (OI). Patients enrolled in the Brittle Bone Disorders (BBD) Contact Registry (CR) will be invited via email to participate in this study.

Detailed description: Population: The RDCRN BBD Contact Registry helps researchers identify and recruit patients who are eligible for participation in future research studies. People eligible for enrollment in the RDCRN BBD Contact Registry include patients and parents of patients with Brittle Bone Disorders. All patients with BBD from the United States and around the world are encouraged to join.

Survey Administration: The investigators will administer a review of pregnancy outcomes survey and delineate the outcomes in pregnancies complicated by varying forms of OI. Patients will be sent an email invitation describing the study. If the participant wants to participate and is eligible, she will follow the survey link in the email message, which directs her to an IRB-approved online consent form. A unique survey link will be generated for each participant and included in the survey invitation, which is a customized email message. This link will allow the investigators to determine who completed the survey. The investigators will send repeat email invitations every two months (total of 3 invitations) to those invitees who have not yet participated. The investigators will allow approximately 6 months for enrollment and survey completion and expect that the study will close soon thereafter.

Data: The survey data will be collected and stored at the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely.

Eligibility criteria: Inclusion Criteria:

* Female with OI who has delivered an infant of at least 24 weeks' gestation
* Participant in the BBD Contact Registry

Exclusion Criteria:

* Inability to provide informed consent and complete survey
* Males
* Women with OI who have not delivered children and gestations associated with higher order multiples

Primary outcomes:
measure: Pregnancy in OI Assessment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: RDCRN Data Management and Coordinating Center, University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Jeffrey Krischer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Deborah Krakow, M.D.
role: PRINCIPAL_INVESTIGATOR
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