Clinical trial NCT06643351: Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia
Official title: Intrapartum Maternal Glucose Control and Effect on Neonatal Hypoglycemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Pregestational Diabetes Mellitus
Neonatal Hypoglycemia
Keywords: Gestational Diabetes
Pregestational Diabetes
Neonatal Hypoglycemia
Intrapartum Glucose
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 218
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.

Detailed description: Neonatal hypoglycemia is a leading cause of admission to the neonatal ICU (NICU) and is associated with increased costs, separation from mothers, and when severe, long term neurological sequelae. Prior research has suggested an association between intrapartum maternal glucose and the risk of neonatal hypoglycemia, so current insulin administration protocols aimed to maintain the blood glucose close to 100mg/dl.

However, recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia, Furthermore, on review of previously established protocols, improved maternal glucose control came with an increased frequency of neonatal hypoglycemia. Thus, these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes.

Few randomized controlled trials (RCTs) exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control. Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life. While another recent RCT found that a permissive blood glucose (up to 180mg/dl) threshold was associated with equivalent neonatal blood glucose levels when compared to the standard, strict thresholds (up to 110mg/dl).

In this study, participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups, either Type 1 Diabetes or Gestational Diabetes(GDM)/Type 2 diabetes. They will then be randomized to one of two intervention groups. The liberalized treatment group will have a target Glucose Range 70 - 160mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound. The standard treatment Group will have a glucose target Glucose Range 70 - 110mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound.

The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients with Pre-gestational (Type 1 or Type 2) or Gestational Diabetes
* Singleton Gestations
* Greater than or equal to 35 weeks gestation
* Planned for vaginal delivery at the University of Pittsburgh Medical Center Magee-Womens Hospital (UPMC MWH)

Exclusion Criteria:

* Major fetal anomalies anticipated to require NICU admission
* Planned Cesarean delivery

Primary outcomes:
measure: Immediate postnatal Neonatal hypoglycemia
timeFrame: Within the first 24 hours after delivery.
Secondary outcomes:
measure: Any neonatal hypoglycemia
timeFrame: Prior to neonatal discharge, up to 42 days after delivery.
measure: Mean neonatal blood glucose
timeFrame: Prior to neonatal discharge, up to 42 days after delivery.
measure: Neonatal Hypoglycemia Requiring IV Treatment
timeFrame: Prior to neonatal discharge, up to 42 days after delivery.
measure: NICU admission
timeFrame: Prior to discharge, up to 42 days after delivery.
measure: Maternal Intrapartum Hyperglycemia
timeFrame: During labor( for up to 200 hours)
measure: Maternal intrapartum hypoglycemia
timeFrame: During labor( for up to 200 hours)
measure: Mean maternal intrapartum blood glucose
timeFrame: During labor( for up to 200 hours)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Praveen Ramesh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dude AM, Niznik C, Peaceman AM, Yee LM. Evaluation of an Intrapartum Insulin Regimen for Women With Diabetes. Obstet Gynecol. 2020 Aug;136(2):411-416. doi: 10.1097/AOG.0000000000003940.
citation: Yamamoto JM, Benham J, Mohammad K, Donovan LE, Wood S. Intrapartum glycaemic control and neonatal hypoglycaemia in pregnancies complicated by diabetes: a systematic review. Diabet Med. 2018 Feb;35(2):173-183. doi: 10.1111/dme.13546.
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: Dude A, Niznik CM, Szmuilowicz ED, Peaceman AM, Yee LM. Management of Diabetes in the Intrapartum and Postpartum Patient. Am J Perinatol. 2018 Sep;35(11):1119-1126. doi: 10.1055/s-0038-1629903. Epub 2018 Mar 13.
citation: Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822.