ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT00850135 के लिए गर्भकालीन मधुमेह वर्तमान में पूर्ण है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes चरण I, चरण II 57 गर्भावस्था
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT00850135 का मुख्य उद्देश्य निदान का अध्ययन करना था। यह चिकित्सकीय अध्ययन गर्भकालीन मधुमेह से जुड़ा हुआ था और यह एक चरण I चरण II हस्तक्रियात्मक परीक्षण था। परीक्षण अब पूर्ण हो चुका है। इसकी शुरुआत 1 फ़रवरी 2009 को हुई थी और इसमें कुल 57 प्रतिभागियों को शामिल किया गया था। स्टैनफोर्ड विश्वविद्यालय ने इस परीक्षण का नेतृत्व किया और यह 1 सितंबर 2015 को पूरा हुआ। ClinicalTrials.gov वेबसाइट पर यह जानकारी 19 मई 2016 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour later. We wish to compare 7-day continuous glucose monit...और दिखाएँ
विस्तृत विवरण
All pregnant patients without pre-existing diabetes will be eligible for the study. Interest in participation will be determined at their initial prenatal visit. Those that are interested will be consented. Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instruc...और दिखाएँ
आधिकारिक शीर्षक
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
स्वास्थ्य स्थितियां
गर्भकालीन मधुमेहप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- SU-02052009-1738
- IRB #12335 (अन्य पहचानकर्ता) (Stanford University Medical Center IRB)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2009-02
अंतिम अद्यतन प्रकाशित
2016-05-19
अध्ययन की समाप्ति तिथि (अनुमानित)
2015-09
नामांकन (अनुमानित)
57
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
चरण II
चरण II
स्थिति
पूर्ण
प्राथमिक उद्देश्य
निदानात्मक
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
अन्यContinuous Glucose Monitor in pregnancy The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data...और दिखाएँ | The Seven Continuous Glucose Monitoring System Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by...और दिखाएँ |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Correlation Between Glucose AUC and Birth Weight. | For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values "AUC-110," "AUC-120," "AUC-130," "AUC-140," and "AUC-180," and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result. | CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000 | For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile.
Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into "high" and "low" at a cutoff of 22,000, which was the 90th percentile of AUC-130 values. | CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
महिला
- Pregnant patients
- Age 18-50
- Gestational age less than 28 weeks
- Minors less than 18 years of age
- Multiple gestation
- Known fetal anomalies
अध्ययन उत्तरदायी पक्ष
Yasser Yehia El-Sayed, मुख्य अन्वेषक, Professor of Obstetrics and Gynecology, Stanford University
कोई संपर्क डेटा नहीं।
2 1 देशों में अध्ययन स्थान
California
Santa Clara Valley Medical Center, San Jose, California, 95128, United States
Stanford University School of Medicine, Stanford, California, 94305, United States