NCT03912363Completed
Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids
Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)
Source: ClinicalTrials.gov · Last updated 12 Jun 2025
Brief summary (registry, in English)
This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 9 Apr 2019
- Start date
- 1 Nov 2019
- Primary completion date
- 30 May 2024
- Lead sponsor
- Geisinger Clinic
- Diseases
- Type 2 diabetes
- NCT number
- NCT03912363
What you commit to
- Study type: Interventional
- Participants enrolled: 114
- From 1 Nov 2019 to the primary completion date, 30 May 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Oral corticosteroid use within 48 hours of planned delivery
- Antenatal corticosteroid use within 7 days of admission for delivery
Other illness
- Women with Type 1 diabetes mellitus or use of insulin pump
- Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery
Age
- Gestational age \< 37 0/7 weeks or \> 40 0/7 weeks
Other
- Evidence of diabetic ketoacidosis at time of admission for delivery
- Multifetal gestation
- Non-English or Non-Spanish speaking
- Anticipated delivery \< 4 hours from randomization (e.g., cervical dilation \> 7 cm at time of randomization, first cesarean delivery of the day)
- Delivery planned outside of GMC or GWV
- Fetal demise
- Prenatal diagnosis of lethal fetal anomaly
Who the study is looking for
- Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2)
- Singleton pregnancies
- Gestational age between 37 0/7 weeks and 40 0/7 weeks
- Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV)
- English or Spanish speaking
- Anticipated delivery at ≥ 4 hours from randomization (e.g., cervical dilation at ≤ 7 cm at time of randomization)
Age in the registry: 14 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Geisinger Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Geisinger Wyoming Valley Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.