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The purpose of this study is to compare intrapartum glycemic control using insulin pump versus intravenous (IV) insulin administration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin pump | Women suffering from pregestational diabetes mellitus and being treated with insulin pump during pregnancy and delivery | ||
| IV insulin | Women suffering from pregestational diabetes mellitus and being treated with insulin sub-cutan (SC) during pregnancy and IV insulin during delivery | ||
| Healthy | Healthy women accepted for delivery in our institute |
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| Measure | Description | Time Frame |
|---|---|---|
| Neonatal hypoglycemia (neonatal capillary blood glucose lowers then 40 mg/dL) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean maternal blood glucose during labor | 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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Inclusion Criteria:
Exclusion Criteria:
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Women suffering from pregestational diabetes mellitus type-1, and are being treated for a minimum of 3 months in the high risk pregnancy clinic in Sheba medical center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagit Shani, MD | Contact | 972-50-7509442 | shani.hagit@gmail.com | |
| Rakefet Yoeli-Ulman, MD | Contact | 972-54-6551819 | rakefety@bezeqint.net |
| Name | Affiliation | Role |
|---|---|---|
| Eyal Sivan, MD. PROF | Sheba Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12039106 | Background | 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. | |
| 18069031 | Background | 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. |
| Label | URL |
|---|---|
| ACOG Committee practice bulletins | View source |
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| Over the course of delivery |
| 15251639 | Background | 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. |
| 10445833 | Background | 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. |