Managing blood sugar levels during labor to reduce newborn hypoglycemia
Intrapartum Maternal Glucose Control and Effect on Neonatal Hypoglycemia
This study is testing if letting blood sugar levels be a bit higher during labor for pregnant women with diabetes can help reduce low blood sugar in their newborns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06643351 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether a more relaxed approach to controlling blood sugar levels during labor in pregnant patients with diabetes can reduce the incidence of neonatal hypoglycemia compared to standard care. It aims to determine if allowing higher blood glucose levels during labor can lead to better outcomes for newborns, who are at risk of hypoglycemia. Participants will be recruited from outpatient visits or upon admission to labor and delivery at Magee-Women's Hospital. The study will compare two different intrapartum glucose target ranges: a standard range and a liberalized range.
Who should consider this trial
Good fit: Ideal candidates include pregnant patients with pregestational or gestational diabetes who are at least 35 weeks gestation and planning a vaginal delivery.
Not a fit: Patients with major fetal anomalies or those planning a cesarean delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of neonatal hypoglycemia and its associated complications.
How similar studies have performed: While some recent studies have explored similar approaches, this specific comparison of liberal versus tight glycemic control during labor is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- Magee-Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Praveen Ramesh, M.D. — University of Pittsburgh
- Study coordinator: Praveen Ramesh, M.D.
- Email: rameshp2@upmc.edu
- Phone: 412-641-4455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.