Frequency of Glucose Monitoring in Labor

Mount Sinai Health System

Status: Completed

Conditions: Neonatal Hypoglycemia

Treatments: Other: Fingerstick

Study type: Interventional

Funder types: Other

Identifiers

NCT06373432

STUDY-22-01607

Details and patient eligibility

About

The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All female patients of reproductive age who have the diagnosis GDM
• Patient with singleton gestation presenting in labor or for induction

Exclusion criteria

• Patients below the age of 18
• Multiple gestation pregnancy
• Patients undergoing scheduled c-section

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

Infrequent testing

Experimental group

Description:

Finger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater)

Treatment:

Other: Fingerstick

Frequent testing

Placebo Comparator group

Description:

Finger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater)

Treatment:

Other: Fingerstick