University of California, Los Angeles
Los Angeles, California, 90069, United States
Location status: Recruiting
NCT Number: NCT05124457
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Los Angeles, California, 90069, United States
Location status: Recruiting
Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are to receive insulin detemir
Patients are to receive insulin NPH
Time frame: Within the first 24 hours of life
Rate (%) of neonatal hypoglycemia
Time frame: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge
Rate (%) of prolonged neonatal hypoglycemia
Time frame: At birth
Sample form cord blood
Time frame: At birth
Sample from cord blood
Time frame: At birth
Sample from cord blood
Time frame: At birth
Sample from cord blood
Time frame: 1 year
Maternal rates of preeclampsia, eclampsia, or gestational hypertension
Time frame: At delivery
Spontaneous vaginal, operative vaginal, cesarean
Time frame: At delivery
Gestational Age at delivery
Time frame: 1 year
Rate (%) of in range maternal blood glucose control in antepartum period
Time frame: 1 year
Total daily insulin dose in patient
Time frame: At birth
Rate (%) of fetal anomolies
Time frame: At birth
Rate (%) of macrosomia
Time frame: At birth
Rate (%) of polyhydramnios
Time frame: At birth
Neonatal weight
Time frame: 1 year
Rate of supplemental oxygen use (%) in neonate
Time frame: 1 year
Rate of dextrose infusion use (%) in neonate
Time frame: 1 year
Rate of RDS (%) in neonate
Time frame: At birth
5 Minute APGAR
Contact information is provided by the study sponsor or research team.
Christina Han, MD
CONTACT
Michael Richley, MD
CONTACT
University of California, Los Angeles
Other
A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
Acronym: DETERMINE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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