Pregnancy in Osteogenesis Imperfecta (OI) Registry

October 15, 2019 updated by: University of South Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • RDCRN Data Management and Coordinating Center, University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Institutes of Health (NIH)
Rare Diseases Clinical Research Network

Investigators

  • Principal Investigator: Jeffrey Krischer, Ph.D., University Of South Florida
  • Principal Investigator: Deborah Krakow, M.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2017

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

September 13, 2019

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBD7705
  • U01TR001263 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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