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This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.
Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Adverse neonatal outcomes include birth injuries, respiratory distress, and metabolic derangements such as hypoglycemia. The incidence of neonatal hypoglycemia is higher in pregnancies complicated by pre-existing DM (24-48%) when compared to patients with GDM (16-19%).
Neonatal hypoglycemia causes immediate and long-term morbidity. Treatment of hypoglycemia may require admission to the Neonatal Intensive Care Unit (NICU). The severity and duration of neonatal hypoglycemia raises concern for permanent neurologic damage to the neonate. Even transient episodes of neonatal hypoglycemia have been associated with neurodevelopmental impairment. It is imperative that measures be taken in diabetic mothers (both pre-existing and gestational) to minimize the risk of neonatal hypoglycemia. While antepartum maternal glucose control remains an important factor in preventing neonatal complications, prevention of maternal hyperglycemia during the intrapartum period has been shown to reduce the risk of neonatal hypoglycemia.
Therapies utilized for maternal intrapartum glycemic control across academic centers in the United States include the use of insulin and rotation of intravenous (IV) fluids. Although used in clinical practice for intrapartum glycemic control, the impact of rotating IV fluids on neonatal blood glucose is unknown. The potential for using rotating IV fluids to control intrapartum blood glucose has several advantages over using insulin for optimization of blood glucose. There is minimal risk of maternal hypoglycemia using IV fluids when compared to insulin therapy. There is also less risk of medication error. IV fluids are easily administered as they do not require separate peripheral access and are easily accessible on a Labor and Delivery (L&D) unit.
The investigators propose a randomized controlled trial (RCT) to assess the effect of maternal intrapartum glycemic control with rotating IV fluids compared to insulin infusion on neonatal blood glucose levels within two hours of birth. The investigators hypothesize neonates born to mothers managed by rotating fluids will have higher neonatal blood glucose levels (closer to normal range) within two hours of birth compared to neonates born to mothers managed by insulin infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotating fluids | Active Comparator | Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery. |
|
| Insulin infusion | Active Comparator | Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotating fluids protocol | Other | IV fluids at a rate of 100-150 ml/hr will be administered:
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal blood glucose value | Neonatal blood glucose value from birth to 2 hours of life | Within 2 hours of life |
| Measure | Description | Time Frame |
|---|---|---|
| Mean neonatal blood glucose value | Average of neonatal blood glucose values from birth to 24 hours of life | First 24 hours of life |
| Incidence of maternal hypoglycemia | Blood glucose value < 50 mg/dL without symptoms OR Blood glucose value < 70 mg/dL with symptoms such as perspiration, palpitations, tremor, weakness, anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Paglia, MD, PhD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger | Danville | Pennsylvania | 17822 | United States | ||
| Geisinger Wyoming Valley |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24945238 | Background | DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415. | |
| 30461693 | Background | American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Randomized controlled trial
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|
| Insulin infusion protocol | Other | Regular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered:
|
|
| During labor (average time 24 hours) |
| Mean intrapartum maternal blood glucose value | Average of maternal blood glucose values during labor | During labor (average time 24 hours) |
| Maternal blood glucose value before delivery | Blood glucose value | Within one hour of delivery |
| Incidence of composite neonatal outcome | Neonatal hypoglycemia, NICU admission, neonatal hyperbilirubinemia, and neonatal respiratory distress syndrome | First 24 hours of life until discharge (average time 21 days) |
| Wilkes-Barre |
| Pennsylvania |
| 18711 |
| United States |
| 18463375 | Background | HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943. |
| 16893507 | Background | Rosenberg VA, Eglinton GS, Rauch ER, Skupski DW. Intrapartum maternal glycemic control in women with insulin requiring diabetes: a randomized clinical trial of rotating fluids versus insulin drip. Am J Obstet Gynecol. 2006 Oct;195(4):1095-9. doi: 10.1016/j.ajog.2006.05.051. Epub 2006 Aug 8. |
| 6753588 | Background | Golde SH, Good-Anderson B, Montoro M, Artal R. Insulin requirements during labor: a reappraisal. Am J Obstet Gynecol. 1982 Nov 1;144(5):556-9. doi: 10.1016/0002-9378(82)90227-7. |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006946 | Hyperinsulinism |