Frequency of Glucose Monitoring in Labor
Not Applicable
Recruiting
- Conditions
- Neonatal Hypoglycemia
- Interventions
- Other: Fingerstick
- Registration Number
- NCT06373432
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infrequent testing Fingerstick Finger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater) Frequent testing Fingerstick Finger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater)
- Primary Outcome Measures
Name Time Method Neonatal Hypoglycemia end of study at 6 months Glucose values of neonate measured in mg/dL
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai West Hospital
🇺🇸New york, New York, United States