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

NCT01158040 | Unknown

• 1 other identifier: SHEBA-10-8014-HS-CTIL
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregestational Diabetes

Keywords

Maternal intrapartum glycemic control; Pregestational diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mean maternal blood glucose during labor

  Over the course of delivery

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• Women not compliant to treatment
• Women not planning their delivery in our institute

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Publications (4)

• 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.

  PMID: 12039106 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.

  PMID: 18069031 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.

  PMID: 15251639 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.

  PMID: 10445833 BACKGROUND

Related Links

• ACOG Committee practice bulletins

Study Officials

• Eyal Sivan, MD. PROF

  Sheba Medical Center

  STUDY DIRECTOR

Central Study Contacts

Hagit Shani, MD

CONTACT

972-50-7509442; shani.hagit@gmail.com

Rakefet Yoeli-Ulman, MD

CONTACT

972-54-6551819; rakefety@bezeqint.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 4, 2010
• First Posted: July 8, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 29, 2010

Record last verified: 2010-07

Locations

IL (1)