Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
170 participants
OBSERVATIONAL
2017-06-16
2019-09-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Participant in the BBD Contact Registry
Exclusion Criteria
* Males
* Women with OI who have not delivered children and gestations associated with higher order multiples
FEMALE
No
Sponsors
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Rare Diseases Clinical Research Network
NETWORK
National Institutes of Health (NIH)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Krischer, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Deborah Krakow, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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RDCRN Data Management and Coordinating Center, University of South Florida
Tampa, Florida, United States
Countries
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References
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McAllion SJ, Paterson CR. Musculo-skeletal problems associated with pregnancy in women with osteogenesis imperfecta. J Obstet Gynaecol. 2002 Mar;22(2):169-72. doi: 10.1080/01443610120113328.
Pennick V, Liddle SD. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2013 Aug 1;(8):CD001139. doi: 10.1002/14651858.CD001139.pub3.
Khovidhunkit W, Epstein S. Osteoporosis in pregnancy. Osteoporos Int. 1996;6(5):345-54. doi: 10.1007/BF01623007.
Pabinger C, Heu C, Frohner A, Dimai HP. Pregnancy- and lactation-associated transient osteoporosis of both hips in a 32 year old patient with osteogenesis imperfecta. Bone. 2012 Jul;51(1):142-4. doi: 10.1016/j.bone.2012.04.013. Epub 2012 May 3.
Choe EY, Song JE, Park KH, Seok H, Lee EJ, Lim SK, Rhee Y. Effect of teriparatide on pregnancy and lactation-associated osteoporosis with multiple vertebral fractures. J Bone Miner Metab. 2012 Sep;30(5):596-601. doi: 10.1007/s00774-011-0334-0. Epub 2011 Nov 23.
Moyer VA; U.S. Preventive Services Task Force. Screening for gestational diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 18;160(6):414-20. doi: 10.7326/M13-2905.
Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.
National Vital Statistics Reports. Center for Disease Control. Volume 64, Number 1. (2015).
Mercer BM. Preterm premature rupture of the membranes: current approaches to evaluation and management. Obstet Gynecol Clin North Am. 2005 Sep;32(3):411-28. doi: 10.1016/j.ogc.2005.03.003.
Callaghan WM, Kuklina EV, Berg CJ. Trends in postpartum hemorrhage: United States, 1994-2006. Am J Obstet Gynecol. 2010 Apr;202(4):353.e1-6. doi: 10.1016/j.ajog.2010.01.011.
Osterman MJ, Martin JA. Epidural and spinal anesthesia use during labor: 27-state reporting area, 2008. Natl Vital Stat Rep. 2011 Apr 6;59(5):1-13, 16.
Osterman MJ, Martin JA, Mathews TJ, Hamilton BE. Expanded data from the new birth certificate, 2008. Natl Vital Stat Rep. 2011 Jul 27;59(7):1-28.
Centers for Disease Control and Prevention (CDC). Update on overall prevalence of major birth defects--Atlanta, Georgia, 1978-2005. MMWR Morb Mortal Wkly Rep. 2008 Jan 11;57(1):1-5.
Wilcox AJ, Weinberg CR, O'Connor JF, Baird DD, Schlatterer JP, Canfield RE, Armstrong EG, Nisula BC. Incidence of early loss of pregnancy. N Engl J Med. 1988 Jul 28;319(4):189-94. doi: 10.1056/NEJM198807283190401.
Jones RK, Jerman J. Abortion incidence and service availability in the United States, 2011. Perspect Sex Reprod Health. 2014 Mar;46(1):3-14. doi: 10.1363/46e0414. Epub 2014 Feb 3.
Ory SJ. The national epidemic of multiple pregnancy and the contribution of assisted reproductive technology. Fertil Steril. 2013 Oct;100(4):929-30. doi: 10.1016/j.fertnstert.2013.06.004. Epub 2013 Jul 19. No abstract available.
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).
Zhang J, Savitz DA. Exercise during pregnancy among US women. Ann Epidemiol. 1996 Jan;6(1):53-9. doi: 10.1016/1047-2797(95)00093-3.
Wang SM, Dezinno P, Maranets I, Berman MR, Caldwell-Andrews AA, Kain ZN. Low back pain during pregnancy: prevalence, risk factors, and outcomes. Obstet Gynecol. 2004 Jul;104(1):65-70. doi: 10.1097/01.AOG.0000129403.54061.0e.
Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernandez-Diaz S; National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol. 2011 Jul;205(1):51.e1-8. doi: 10.1016/j.ajog.2011.02.029. Epub 2011 Apr 22.
Other Identifiers
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BBD7705
Identifier Type: -
Identifier Source: org_study_id
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