Pregnancy in Osteogenesis Imperfecta (OI) Registry

Osteogenesis Imperfecta Clinical Trial

Official title:

Pregnancy in Osteogenesis Imperfecta (OI) Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072303
• Other study ID #: BBD7705
• Secondary ID: U01TR001263
• Status: Completed
• Start date: June 16, 2017
• Est. completion date: September 13, 2019

Study information

• Verified date: October 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Brittle Bone Disorders
• Osteogenesis Imperfecta

Intervention

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.

Locations

Country	Name	City	State
United States	RDCRN Data Management and Coordinating Center, University of South Florida	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of South Florida	National Institutes of Health (NIH), Rare Diseases Clinical Research Network

Country where clinical trial is conducted

United States, 

References & Publications (21)

Arias E. United States Life Tables, 2011. Natl Vital Stat Rep. 2015 Sep 22;64(11):1-63. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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).

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. — View Citation

Khovidhunkit W, Epstein S. Osteoporosis in pregnancy. Osteoporos Int. 1996;6(5):345-54. Review. — View Citation

McAllion SJ, Paterson CR. Musculo-skeletal problems associated with pregnancy in women with osteogenesis imperfecta. J Obstet Gynaecol. 2002 Mar;22(2):169-72. — View Citation

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. Review. — View Citation

Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernández-Díaz 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. — View Citation

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. — View Citation

National Vital Statistics Reports. Expanded Data From the New Birth Certificate. Center for Disease Control. Volume 59, Number 7 (2011).

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;(9):CD001139. — View Citation

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).

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. — View Citation

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. — View Citation

Zhang J, Savitz DA. Exercise during pregnancy among US women. Ann Epidemiol. 1996 Jan;6(1):53-9. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy in OI Assessment	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