Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial
NCT ID: NCT01158040
Last Updated: 2010-07-29
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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UNKNOWN
88 participants
OBSERVATIONAL
2010-08-31
2012-08-31
Brief Summary
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Detailed Description
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The study is a cohort prospective and retrospective observational study in the tertiary center - Sheba medical center.
Conditions
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Keywords
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Study Design
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COHORT
Study Groups
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Insulin pump
Women suffering from pregestational diabetes mellitus and being treated with insulin pump during pregnancy and delivery
No interventions assigned to this group
IV insulin
Women suffering from pregestational diabetes mellitus and being treated with insulin sub-cutan (SC) during pregnancy and IV insulin during delivery
No interventions assigned to this group
Healthy
Healthy women accepted for delivery in our institute
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Women are being treated for a minimum of 3 months in the high risk pregnancy clinic in Sheba medical center
* Women are being treated with either insulin pump or SC insulin (basal-bolus)
Exclusion Criteria
* Women not planning their delivery in our institute
18 Years
50 Years
FEMALE
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Sheba Medical Center
Principal Investigators
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Eyal Sivan, MD. PROF
Role: STUDY_DIRECTOR
Sheba Medical Center
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Hagit Shani, MD
Role: primary
Rakefet Yoeli-Ulman, MD
Role: backup
References
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Taylor R, Lee C, Kyne-Grzebalski D, Marshall SM, Davison JM. Clinical outcomes of pregnancy in women with type 1 diabetes(1). Obstet Gynecol. 2002 Apr;99(4):537-41. doi: 10.1016/s0029-7844(01)01790-2.
Lepercq J, Abbou H, Agostini C, Toubas F, Francoual C, Velho G, Dubois-Laforgue D, Timsit J. A standardized protocol to achieve normoglycaemia during labour and delivery in women with type 1 diabetes. Diabetes Metab. 2008 Feb;34(1):33-7. doi: 10.1016/j.diabet.2007.08.003.
Jovanovic L. Glucose and insulin requirements during labor and delivery: the case for normoglycemia in pregnancies complicated by diabetes. Endocr Pract. 2004 Mar-Apr;10 Suppl 2:40-5. doi: 10.4158/EP.10.S2.40.
Carron Brown S, Kyne-Grzebalski D, Mwangi B, Taylor R. Effect of management policy upon 120 Type 1 diabetic pregnancies: policy decisions in practice. Diabet Med. 1999 Jul;16(7):573-8. doi: 10.1046/j.1464-5491.1999.00124.x.
Related Links
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ACOG Committee practice bulletins
Other Identifiers
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SHEBA-10-8014-HS-CTIL
Identifier Type: -
Identifier Source: org_study_id