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

NCT ID: NCT01158040

Last Updated: 2010-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregestational Diabetes

Keywords

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Maternal intrapartum glycemic control Pregestational diabetes

Study Design

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Observational Model Type

COHORT

Study Groups

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Insulin pump

Women suffering from pregestational diabetes mellitus and being treated with insulin pump during pregnancy and delivery

No interventions assigned to this group

IV insulin

Women suffering from pregestational diabetes mellitus and being treated with insulin sub-cutan (SC) during pregnancy and IV insulin during delivery

No interventions assigned to this group

Healthy

Healthy women accepted for delivery in our institute

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Eyal Sivan, MD. PROF

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Hagit Shani, MD

Role: CONTACT

Phone: 972-50-7509442

Email: [email protected]

Rakefet Yoeli-Ulman, MD

Role: CONTACT

Phone: 972-54-6551819

Email: [email protected]

Facility Contacts

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Hagit Shani, MD

Role: primary

Rakefet Yoeli-Ulman, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 12039106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18069031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15251639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10445833 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/sites/pubmed

ACOG Committee practice bulletins

Other Identifiers

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SHEBA-10-8014-HS-CTIL

Identifier Type: -

Identifier Source: org_study_id