Save this study. Warning You have reached the maximum number of saved studies Comparison of Glucovance to Insulin for Diabetes During Pregnancy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Recruitment status was: Recruiting First Posted : September 4, Last Update Posted : April 20, Study Description.
Pregnant women with gestational or Type 2 diabetes who require medication are placed in one of two groups: Insulin injections or Glucovance oral administration. Blood glucose is checked 5 times per day, and medication adjusted by perinatologist according to glucose levels.
The hypothesis is that patients will have similar or improved blood glucose control on an oral agent as compared to control on insulin. Detailed Description:. According to ACOG guidelines, patients between 24 and 28 weeks gestation will be screened with a 1 hour glucose tolerance test GTT by their obstetrician.
Those with elevated glucose levels will undergo a 3 hour GTT. Type 2 diabetics who have been diagnosed prior to pregnancy will also be included. These patients may enroll in the study prior to 24 weeks gestation, entering at the time of referral. Patients who give consent for participation will be randomly assigned to either insulin therapy the usual standard of care , or to oral Glucovance therapy the experimental group. Glucovance will be started at 1. Both groups will receive care according to the current standard for gestational diabetics and pregnant Type 2 diabetics.
The perinatologist and diabetes educator will evaluate the blood glucose record and assess the patient's adherence to the ADA diet weekly and will determine when the insulin or Glucovance needs to be increased. Statistical analysis will compare the two groups for myriad factors including vaginal versus operative deliveries, hemoglobin A1C, fructosamine, and glucose at delivery, infant birth weight, infant complications, initial infant blood glucose.
FDA Resources. Arms and Interventions. Outcome Measures. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. However, you may need to stop taking glyburide and metformin for a short time just before your due date. Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. If you also take colesevelam, avoid taking it within 4 hours after you take glyburide and metformin. Use Glucovance Glyburide And Metformin exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Call your doctor if you are sick with vomiting, diarrhea, or a fever. These conditions can lead to severe dehydration, which could be dangerous while you are taking glyburide and metformin. You may have low blood sugar hypoglycemia and feel very hungry, dizzy, irritable, confused, anxious, or shaky.
To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar fruit juice, hard candy, crackers, raisins, or non-diet soda. Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar hyperglycemia such as increased thirst or urination. Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
Glyburide and metformin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely. Your doctor may have you take extra vitamin B12 while you are taking glyburide and metformin. Take only the amount of vitamin B12 that your doctor has prescribed. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.
Do not take two doses at one time. Health Topics. Health Tools.
0コメント