insulin-detemir has been researched along with Abortion--Spontaneous* in 3 studies
2 trial(s) available for insulin-detemir and Abortion--Spontaneous
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Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial.
Insulin detemir, being used increasingly during pregnancy, may have pharmacologic benefits compared with neutral protamine Hagedorn.. We evaluated the probability that compared with treatment with neutral protamine Hagedorn, treatment with insulin detemir reduces the risk for adverse neonatal outcome among individuals with type 2 or overt type 2 diabetes mellitus (gestational diabetes mellitus diagnosed at <20 weeks' gestation).. We performed a multiclinic randomized controlled trial (September 2018 to January 2020), which included women with singleton gestation with type 2 or overt type 2 diabetes mellitus who sought obstetrical care at ≤21 weeks' gestation. Participants were randomized to receive either insulin detemir or neutral protamine Hagedorn by a clinic-stratified scheme. The primary outcome was a composite of adverse neonatal outcomes, including shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need of at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia. The secondary neonatal outcomes included gestational age at delivery, small for gestational age, 5-minute Apgar score of <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay. The secondary maternal outcomes included hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications. We used the Bayesian statistics to estimate a sample size of 108 to have >75% probability of any reduction in the primary outcome, assuming 80% power and a hypothesized effect of 33% reduction with insulin detemir. All analyses were intent to treat under a Bayesian framework with neutral priors (a priori assumed a 50:50 likelihood of either intervention being better; National Clinical Trial identifier 03620890).. There were 108 women randomized in this trial (57 in insulin detemir and 51 in neutral protamine Hagedorn), and 103 women were available for analysis of the primary outcome (n=5 for pregnancy loss before 24 weeks' gestation). Bayesian analysis indicated an 87% posterior probability of reduced primary outcome with insulin detemir compared with neutral protamine Hagedorn (posterior adjusted relative risk, 0.88; 95% credible interval, 0.61-1.12). Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with the use of insulin detemir vs neutral protamine Hagedorn: for example, maternal hypoglycemic events (97% probability of benefit; posterior adjusted relative risk, 0.59; 95% credible interval, 0.29-1.08) and hypertensive disorders (88% probability of benefit; posterior adjusted relative risk, 0.81; 95% credible interval, 0.54-1.16).. In our comparative effectiveness trial involving individuals with type 2 or overt type 2 diabetes mellitus, use of insulin detemir resulted in lower rates of adverse neonatal and maternal outcomes compared with neutral protamine Hagedorn. Topics: Abortion, Spontaneous; Adult; Diabetes Mellitus, Type 2; Female; Fetal Macrosomia; Gestational Age; Humans; Hypoglycemia; Infant, Newborn; Insulin Detemir; Insulin, Isophane; Intensive Care, Neonatal; Pregnancy; Pregnancy Complications; Pregnancy in Diabetics; Pregnancy Outcome; Respiratory Distress Syndrome, Newborn; Shoulder Dystocia | 2021 |
A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes.
This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented.. Subjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks.. For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments.. IDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified. Topics: Abortion, Induced; Abortion, Spontaneous; Congenital Abnormalities; Diabetes Mellitus, Type 1; Drug Combinations; Female; Fetal Death; Gestational Age; Humans; Hypoglycemic Agents; Insulin Aspart; Insulin Detemir; Insulin, Isophane; Insulin, Long-Acting; Live Birth; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome; Pregnancy, Ectopic | 2014 |
1 other study(ies) available for insulin-detemir and Abortion--Spontaneous
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BENEFITS OF EARLY SCREENING AND PROPER TREATMENT IN PATIENT WITH SIGNIFICANT RISK FACTORS FOR GESTATIONAL DIABETES MELLITUS (CASE REPORT).
Gestational diabetes mellitus (GDM) occurs in 2-9% of all pregnancies. Evidence suggests that the use of insulin in treating hyperglycemia in GDM patients reduces the risk of perinatal morbidity. Pregnancy is an exciting time in a woman's life. However, once patient is diagnosed with GDM, she will be managed more intensively. GDM is managed using diet and exercise but one in six women with GDM requires insulin. A 35-year-old woman at the 14th gestational week of her tenth pregnancy was seen for routine prenatal care. She had the history of nine consecutive spontaneous abortions. Patient was hospitalized and based on the revealed glucose values insulin therapy was initiated with long-acting insulin analogue - Levemir and rapid-acting insulin analogue - NovoRapid. Patient's diabetes was compensated on insulin therapy. Follow-ups were planned at intervals of 1-2 weeks depending on the glucose levels. This is the case report of a GDM in a high-risk patient. She's at the 21st gestational weeks and has passed "delicate weeks". At her 21st week of gestation patient's glucose levels are compensated on insulin therapy and she is feeling well. In this unusual case report, no insulin therapy had been started during previous pregnancies, so we managed to achieve a good glycemic control with insulin treatment. This could be one of the factors that could help a normal pregnancy and delivery. The discussion should be focusing on early screening and proper treatment for GDM. Topics: Abortion, Spontaneous; Adult; Diabetes Mellitus, Type 2; Diabetes, Gestational; Drug Therapy, Combination; Female; Humans; Hypoglycemic Agents; Insulin Aspart; Insulin Detemir; Mutation; Pregnancy; Risk Factors | 2018 |