Clinical trial NCT03912363: Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids
Official title: Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes Mellitus
Gestational Diabetes Mellitus
Keywords: intrapartum
glycemic control
diabetes
insulin
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 114
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2)
* Singleton pregnancies
* Gestational age between 37 0/7 weeks and 40 0/7 weeks
* Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV)
* English or Spanish speaking
* Anticipated delivery at ≥ 4 hours from randomization (e.g., cervical dilation at ≤ 7 cm at time of randomization)

Exclusion Criteria:

* Women with Type 1 diabetes mellitus or use of insulin pump
* Evidence of diabetic ketoacidosis at time of admission for delivery
* Multifetal gestation
* Gestational age \< 37 0/7 weeks or \> 40 0/7 weeks
* Non-English or Non-Spanish speaking
* Anticipated delivery \< 4 hours from randomization (e.g., cervical dilation \> 7 cm at time of randomization, first cesarean delivery of the day)
* Oral corticosteroid use within 48 hours of planned delivery
* Antenatal corticosteroid use within 7 days of admission for delivery
* Delivery planned outside of GMC or GWV
* Fetal demise
* Prenatal diagnosis of lethal fetal anomaly
* Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery

Primary outcomes:
measure: Neonatal blood glucose value
timeFrame: Within 2 hours of life
Secondary outcomes:
measure: Mean neonatal blood glucose value
timeFrame: First 24 hours of life
measure: Incidence of maternal hypoglycemia
timeFrame: During labor (average time 24 hours)
measure: Mean intrapartum maternal blood glucose value
timeFrame: During labor (average time 24 hours)
measure: Maternal blood glucose value before delivery
timeFrame: Within one hour of delivery
measure: Incidence of composite neonatal outcome
timeFrame: First 24 hours of life until discharge (average time 21 days)
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Michael J Paglia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.