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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01158040
First received: July 4, 2010
Last updated: July 28, 2010
Last verified: July 2010
  Purpose

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


Condition
Pregestational Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Neonatal hypoglycemia (neonatal capillary blood glucose lowers then 40 mg/dL) [ Time Frame: Up to 2 hours postpartum ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Mean maternal blood glucose during labor [ Time Frame: Over the course of delivery ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 88
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158040

Contacts
Contact: Hagit Shani, MD 972-50-7509442 shani.hagit@gmail.com
Contact: Rakefet Yoeli-Ulman, MD 972-54-6551819 rakefety@bezeqint.net

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52621
Contact: Hagit Shani, MD    972-50-7509442    shani.hagit@gmail.com   
Contact: Rakefet Yoeli-Ulman, MD    972-54-6551819    rakefety@bezeqint.net   
Principal Investigator: Hagit Shani, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Eyal Sivan, MD. PROF Sheba Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Hagit Shani MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01158040     History of Changes
Other Study ID Numbers: SHEBA-10-8014-HS-CTIL
Study First Received: July 4, 2010
Last Updated: July 28, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Maternal intrapartum glycemic control
Pregestational diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014