NCT03072303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 16, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

January 25, 2017

Last Update Submit

October 15, 2019

Conditions

Osteogenesis ImperfectaBrittle Bone Disorders

Keywords

Brittle BoneOsteogenesis ImperfectaBBDOICongenital AbnormalitiesCongenital Bone DisorderLobstein Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Web-based SurveyOTHER

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

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RDCRN Data Management and Coordinating Center, University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (21)

  • 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.

    PMID: 12521699BACKGROUND

  • 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.

    PMID: 23904227BACKGROUND

  • Khovidhunkit W, Epstein S. Osteoporosis in pregnancy. Osteoporos Int. 1996;6(5):345-54. doi: 10.1007/BF01623007.

    PMID: 8931028BACKGROUND

  • 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.

    PMID: 22579778BACKGROUND

  • 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.

    PMID: 22105654BACKGROUND

  • 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.

    PMID: 24424622BACKGROUND

  • 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.

    PMID: 24150027BACKGROUND

  • 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.

    PMID: 15760246BACKGROUND

  • National Vital Statistics Reports. Center for Disease Control. Volume 64, Number 1. (2015).

    BACKGROUND

  • 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.

    PMID: 16125041BACKGROUND

  • 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.

    PMID: 20350642BACKGROUND

  • 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.

    PMID: 21553556BACKGROUND

  • 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.

    PMID: 21848043BACKGROUND

  • 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.

    PMID: 18185492BACKGROUND

  • 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.

    PMID: 3393170BACKGROUND

  • 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.

    PMID: 24494995BACKGROUND

  • 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.

    PMID: 23876531BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    PMID: 8680626BACKGROUND

  • 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.

    PMID: 15229002BACKGROUND

  • 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.

    PMID: 21514558BACKGROUND

MeSH Terms

Conditions

Osteogenesis ImperfectaCongenital Abnormalities

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeffrey Krischer, Ph.D.

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Deborah Krakow, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

March 7, 2017

Study Start

June 16, 2017

Primary Completion

March 13, 2019

Study Completion

September 13, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)