NCT03912363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

4.6 years

First QC Date

April 9, 2019

Last Update Submit

June 10, 2025

Conditions

Type II Diabetes MellitusGestational Diabetes Mellitus

Keywords

intrapartumglycemic controldiabetesinsulin

Outcome Measures

Primary Outcomes (1)

  • Neonatal blood glucose value

    Neonatal blood glucose value from birth to 2 hours of life

    Within 2 hours of life

Secondary Outcomes (5)

  • Mean neonatal blood glucose value

    First 24 hours of life

  • Incidence of maternal hypoglycemia

    During labor (average time 24 hours)

  • Mean intrapartum maternal blood glucose value

    During labor (average time 24 hours)

  • Maternal blood glucose value before delivery

    Within one hour of delivery

  • Incidence of composite neonatal outcome

    First 24 hours of life until discharge (average time 21 days)

Study Arms (2)

Rotating fluids

ACTIVE COMPARATOR

Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery.

Other: Rotating fluids protocol

Insulin infusion

ACTIVE COMPARATOR

Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery.

Other: Insulin infusion protocol

Interventions

Rotating fluids protocolOTHER

IV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose \< 100 mg/dL or less: IV fluids with 5% dextrose * For blood glucose between 101-140 mg/dL: IV fluids without 5% dextrose * For blood glucose \> 140 mg/dL on two consecutive occasions: insulin infusion protocol (Study arm 2)

Rotating fluids
Insulin infusion protocolOTHER

Regular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose \< 80 mg/dL: No insulin AND IV fluids with 5% dextrose * For blood glucose 80-100 mg/dL: Insulin at 0.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 101-140 mg/dL: Insulin at 1.0 U/hr AND IV fluids with 5% dextrose * For blood glucose 141-180 mg/dL: Insulin at 1.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 181-220 mg/dL: Insulin at 2.0 U/hr AND IV fluid without dextrose * For blood glucose \> 220 mg/dL: Insulin at 2.5 U/hr AND IV fluids without dextrose

Insulin infusion

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (5)

  • 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.

    PMID: 24945238BACKGROUND

  • 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.

    PMID: 30461693BACKGROUND

  • 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.

    PMID: 18463375BACKGROUND

  • 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.

    PMID: 16893507BACKGROUND

  • 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.

    PMID: 6753588BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes, GestationalDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHyperinsulinism

Study Officials

  • Michael J Paglia, MD, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 11, 2019

Study Start

November 1, 2019

Primary Completion

May 30, 2024

Study Completion

March 1, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations

US(2)