Intrapartum Glycemic Control in GDMA2

Inova Health Care Services

Status: Terminated

Conditions: Neonatal Hypoglycemia; Gestational Diabetes Mellitus, Class A2; Pregnancy

Treatments: Other: Blood sugar check every 2 hours; Other: Blood sugar check every 4 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT05647798

U22-01-4642

Protocol #20222678 U22-01-4642 (Other Identifier)

Details and patient eligibility

About

This is a randomized, parallel, controlled, non-inferiority trial to assess the impact of a tight versus a more liberalized intrapartum glycemic control in gestational diabetic mothers on neonatal glycemia. National guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to the scarcity of high-quality data on the topic.

Full description

Gestational diabetes mellitus (GDM) remains a common pregnancy complication, affecting 6-15% of pregnancies worldwide. The incidence of GDM is expected to continue its global upward trend in light of the growing obesity epidemic and delayed childbearing. GDM is associated with adverse short- and long-term maternal and offspring outcomes. Neonatal hypoglycemia, as a result of fetal hyperinsulinemia, occurs in up to 35% of pregnancies complicated by GDM with potential long-term neurodevelopmental sequelae. In that regard, significant emphasis has been placed on the prevention of neonatal hypoglycemia through optimal maternal glycemic control. Available data are conflicting as to the contribution of intrapartum glycemia to neonatal glycemia.

Moreover, national guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to a lack of high-quality data on the topic. As far as we are aware, only one single center randomized controlled trial has been published on the topic. That study's findings suggest that an approach to a more liberalized intrapartum glycemic management was not associated with a higher rate of neonatal hypoglycemia compared to a tight glycemic control regimen. We propose to replicate these findings in a different population at our institution. If this more relaxed approach to intrapartum glycemic management is confirmed to be safe to women and their babies, its clinical application has the potential to decrease the inconvenience of frequent finger pricks for our patients during labor and allow more efficient allocation of resources for the nursing staff on an already labor-intensive unit.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women 18 years or older
• Non-anomalous singleton gestation
• Gestational diabetes type A2 diagnosed at 24 weeks' gestation or beyond
• Planned vaginal delivery at term at Inova Fairfax Women's Hospital

Exclusion criteria

• Women < 18 years
• Fetus with major congenital malformations
• Twin or higher order gestation
• Pre-existing diabetes mellitus
• Exposure to antenatal or any systemic steroids 14 days or less prior to delivery
• Preterm delivery
• Scheduled cesarean birth
• Intrapartum cesarean birth prior to 4-5 cm of cervical dilatation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Usual care glycemic management arm

Active Comparator group

Description:

Blood glucose will be checked every 2 hours during labor and glucose target will be 75-110 mg/dl

Treatment:

Other: Blood sugar check every 2 hours

More liberalized glycemic management arm

Active Comparator group

Description:

Blood glucose will be checked every 4 hours during labor and glucose target will be 70-126 mg/dl

Treatment:

Other: Blood sugar check every 4 hours