Comparing glucose and insulin treatment to glucose alone for diabetic women during labor
Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial
This study tests if giving diabetic women both glucose and insulin during labor can help prevent low blood sugar in their newborns better than giving glucose alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Trial ID | NCT03273881 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of administering intravenous glucose combined with constant insulin infusion versus glucose alone in diabetic women during labor. Pregnant women diagnosed with gestational or pregestational diabetes will be randomly assigned to one of two groups: one receiving both glucose and insulin, and the other receiving glucose only. The primary focus is to assess the incidence of neonatal hypoglycemia, a common complication in these pregnancies. The study aims to provide clearer guidelines for managing glycemic control during labor to improve neonatal outcomes.
Who should consider this trial
Good fit: Ideal candidates include pregnant women over 37 weeks gestation with gestational or pregestational diabetes.
Not a fit: Patients with intrauterine fetal death, low estimated fetal weight, multiple gestations, or major fetal malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of neonatal hypoglycemia in diabetic pregnancies.
How similar studies have performed: Previous studies have suggested various intravenous treatment protocols, but this specific comparison of glucose with and without insulin during labor is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>37 weeks gestation * gestational diabetes mellitus according to Carpenter and Coustan * pregestational diabetes mellitus Exclusion Criteria: * Intrauterine fetal death * estimated fetal weight\<10p * multiple gestation * major fetal malformations
Where this trial is running
Afula
- HaEmek medical center — Afula, Israel (Recruiting)
Study contacts
- Principal investigator: Gali Gali, MD — HaEmemk Medical Center, Afula, Israel.
- Study coordinator: Gali Gali, MD
- Email: galit_ga@clalit.org.il
- Phone: 972-4-6494035
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.