Clinical trial NCT01158040: Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial
Official title: Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregestational Diabetes
Keywords: Maternal intrapartum glycemic control
Pregestational diabetes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-08
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
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.

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

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 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

Primary outcomes:
measure: Neonatal hypoglycemia (neonatal capillary blood glucose lowers then 40 mg/dL)
timeFrame: Up to 2 hours postpartum
Secondary outcomes:
measure: Mean maternal blood glucose during labor
timeFrame: Over the course of delivery
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Eyal Sivan, MD. PROF
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/s0029-7844(01)01790-2.
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. doi: 10.1016/j.diabet.2007.08.003.
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. doi: 10.4158/EP.10.S2.40.
citation: 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.