- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158040
Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial
Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial
Study Overview
Status
Conditions
Detailed Description
Intrapartum maternal glycemic control in women suffering from pregestational diabetes mellitus type 1 will be evaluated and compared in the 3 study groups. Maternal and neonatal capillary blood glucose will be measured. All women suffering from diabetes mellitus and all neonates to hyperglycemic mothers are being tested for their blood glucose in our institute. Measurements' data will be collected. The primary outcome of the study is the number of neonatal hypoglycemic events (neonatal blood glucose < 40mg/dL). All women participating in the study will be treated according to the standard accepted protocol for "the treatment of pregestational diabetes during labor" in our institute. The research will not include new treatments or equipment.
The study is a cohort prospective and retrospective observational study in the tertiary center - Sheba medical center.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hagit Shani, MD
- Phone Number: 972-50-7509442
- Email: shani.hagit@gmail.com
Study Contact Backup
- Name: Rakefet Yoeli-Ulman, MD
- Phone Number: 972-54-6551819
- Email: rakefety@bezeqint.net
Study Locations
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-
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Contact:
- Hagit Shani, MD
- Phone Number: 972-50-7509442
- Email: shani.hagit@gmail.com
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Contact:
- Rakefet Yoeli-Ulman, MD
- Phone Number: 972-54-6551819
- Email: rakefety@bezeqint.net
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Principal Investigator:
- Hagit Shani, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women suffering from pregestational diabetes mellitus type-1,
- 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 compliant to treatment
- Women not planning their delivery in our institute
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Insulin pump
Women suffering from pregestational diabetes mellitus and being treated with insulin pump during pregnancy and delivery
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IV insulin
Women suffering from pregestational diabetes mellitus and being treated with insulin sub-cutan (SC) during pregnancy and IV insulin during delivery
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Healthy
Healthy women accepted for delivery in our institute
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal hypoglycemia (neonatal capillary blood glucose lowers then 40 mg/dL)
Time Frame: Up to 2 hours postpartum
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All neonates to mothers who suffer from diabetes mellitus are being routinely tested for neonatal hypoglycemia in our department.
Their capillary blood glucose level is being tested in the first 2 hours postpartum.
Data will be gathered and compared in women being treated with insulin pump during labor versus women being treated with IV insulin
|
Up to 2 hours postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean maternal blood glucose during labor
Time Frame: Over the course of delivery
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All women suffering from pregestational diabetes mellitus are being routinely tested for blood glucose levels during delivery in our department.
Their capillary blood glucose level is being tested every 1 hour throughout the active phase of delivery.
Mean maternal blood glucose during partum will be compared in women being treated with insulin pump during labor versus women being treated with IV insulin
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Over the course of delivery
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eyal Sivan, MD. PROF, Sheba Medical Center
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-10-8014-HS-CTIL
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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