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治験 NCT06874907 (GLUCO-GCM)（対象：妊娠中の妊娠糖尿病）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring. (GLUCO-GCM) 1,000
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06874907 (GLUCO-GCM) は 観察研究 臨床試験 で、妊娠中の妊娠糖尿病 に関するものです。現在は 募集中 で、2025年3月1日 から開始しています。1,000 名の参加者 の募集が計画されています。この試験は Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia によって主導され、2026年7月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年3月13日 です。
概要
Gestational diabetes mellitus (GDM) is the most common complication of pregnancy, with an incidence rate of 10-15% \[1\]. Common risk factors for GDM are increased maternal age and weight and as a consequence of women delaying childbirth and increasing incidence of obesity, there is a corresponding increase in the rate of GDM. GDM is associated with an increased risk of maternal and perinatal short and long-term comp...もっと見る
公式タイトル
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
疾患名
妊娠中の妊娠糖尿病その他の研究識別子
- GLUCO-GCM
- IMIB-GLC-2023-03
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Continuous glucose monitoring First trimester prediction of gestational diabetes mellitus by continuous glucose monitoring | Glucose monitoring Glucose monitoring |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus ) | GDM is defined by abnormal results of 75mg OGTT(Oral Glucose Tolerance Test) at 28 weeks' gestation | Up to 28 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of patients with Gestational hypertension | blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has no proteinuria (excess protein in the urine) | Up to 28 weeks |
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of patients with Delivery by caesarean section | Up to 28 weeks |
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of patients with Stillbirth, neonatal death, perinatal death | Up to 28 weeks |
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of patients with Large for gestational age neonate (\>90th and 95th percentile for gestation) | Up to 28 weeks |
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of patients with Neonatal hyperglycaemia | Up to 28 weeks |
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of patients with Neonatal hyperbilirubinemia | Up to 28 weeks |
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of patients with Neonatal unit (NNU) admission for ≥48 hours | Up to 28 weeks |
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of days (Length of stay) in the Neonatal Intensive Unit. | Up to 28 weeks |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
女性
- Maternal age ≥ 18 years
- Planned antenatal care at the same centre (i.e. not planning to move before delivery).
- Singleton pregnancy.
- Informed and written consent.
Age <18 years;
Multiple pregnancy in current pregnancy;
- Unconscious or very ill; · Serious mental illness;
- Learning difficulties;
- Not fluent in local language and absence of interpreter;
- Severe congenital anomaly on ultrasound;
- Pre-existing diabetes mellitus type 1 or 2;
- Patients undergoing metformin therapy for infertility.
- Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (<1 year);
- Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR <60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results;
- Participating in another intervention study that influences outcomes of this study;
- Allergy to adhesive materials;
- Allergy to any of the components of the glucose test:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaKing's College Hospital NHS Trust試験中央連絡先
連絡先: Catalina de Paco Matallana, MD, 968369500, [email protected]
1 1カ国の場所
Murcia
HCUVA, El Palmar, Murcia, 30120, Spain
募集中