Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial

Pregestational Diabetes Clinical Trial

Official title:

Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01158040
• Other study ID #: SHEBA-10-8014-HS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 4, 2010
• Last updated: July 28, 2010
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: July 2010
• Source: Sheba Medical Center
• Contact: Hagit Shani, MD
• Phone: 972-50-7509442
• Email: shani.hagit[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare intrapartum glycemic control using insulin pump versus intravenous (IV) insulin administration.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Pregestational Diabetes

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Over the course of delivery	Yes

External Links

•   ACOG Committee practice bulletins