At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 70 enrolled
Drug / intervention
Insulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial
In Brief
A Phase 4 clinical trial evaluating Insulin for Type 1 Diabetes and Pregnancy, High Risk. Completed, enrolled 70 participants across 1 site.
Detailed Summary
The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes, Pregnancy, High Risk
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartMar 2021
Primary CompletionMay 2023
Study CompletionMay 2023
TodayJul 2026
First PostedOct 22, 2020
Enrollment StartMar 15, 2021
Primary CompletionMay 1, 2023
Study CompletionMay 2, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.7 years ago
Interventions
Insulindrug
IV Insulin Infusion
Insulindrug
Continuous Subcutaneous Insulin Infusion (Pump)