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Pregnancy in Osteogenesis Imperfecta (OI) Registry

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ClinicalTrials.gov Identifier: NCT03072303
Recruitment Status : Active, not recruiting
First Posted : March 7, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
Rare Diseases Clinical Research Network
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment
Osteogenesis Imperfecta Brittle Bone Disorders Other: Web-based Survey

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregnancy in Osteogenesis Imperfecta (OI) Registry
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019



Intervention Details:
  • Other: Web-based Survey
    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.


Primary Outcome Measures :
  1. Pregnancy in OI Assessment [ Time Frame: 1 year ]
    The goal of this survey is to characterize the course and outcome of pregnancy in individuals with OI. This is a self-report survey that will review pregnancy outcomes (maternal and fetal). Measures of pregnancy outcome will include 1) length of gestation, 2) mode of delivery, 3) neonatal outcomes including birth weight and length, 4) history of back pain or hip pain and or fractures during pregnancy or postpartum 5) number of maternal hospital admissions 6) calcium and vitamin D intake, 7) neonatal complications and 8) OI status in the fetus. One survey will be completed for each gestation (pregnancy).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072303


Locations
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United States, Florida
RDCRN Data Management and Coordinating Center, University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Rare Diseases Clinical Research Network
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Jeffrey Krischer, Ph.D. University of South Florida
Principal Investigator: Deborah Krakow, M.D. University of California, Los Angeles

Publications:
Roberts, JM., August, PA., Bakris G. et al. American College of Obstetricians and Gynecologists. Task Force on Hypertension in Pregnancy, author. Hypertension in pregnancy / developed by the Task Force on Hypertension in Pregnancy. 1122-31 (2013).
National Vital Statistics Reports. Expanded Data From the New Birth Certificate. Center for Disease Control. Volume 59, Number 7 (2011).
Jebeile, H et al. A systematic review and meta-analysis of energy intake and weight gain in pregnancy. Institute of Medicine, Food and Nutrition Board, Committee on Nutritional Status During Pregnancy, part I: Nutritional Status and Weight Gain. National Academy Press, Washington, DC 2000. Am J Obstet Gynecol 12(2015).

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03072303     History of Changes
Other Study ID Numbers: BBD7705
U01TR001263 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of South Florida:
Brittle Bone
Osteogenesis Imperfecta
BBD
OI
Congenital Abnormalities
Congenital Bone Disorder
Lobstein Syndrome
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Bone Diseases
Osteochondrodysplasias
Bone Diseases, Developmental
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases