التفاصيل البيبلوغرافية
| العنوان: |
SUGAR-DIP trial:oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial |
| المؤلفون: |
Wit, Leon de, Rademaker, Doortje, Voormolen, Daphne N, Akerboom, Bettina MC, Kiewiet-Kemper, Rosalie M, Soeters, Maarten R, Verwij-Didden, Marion AL, Assouiki, Fahima, Schippers, D H, Vermeulen, Mechteld AR, Kuppens, SMI, Oosterwerff, Mirjam M, Zwart, Joost J, Diekman, Mattheus JM, Vogelvang, Tatjana E, Gallas, P Rob J, Galjaard, Sander, Visser, Willy, Horree, Nicole, Klooker, Tamira K, Laan, Rosemarie, Heijligenberg, Rik, Huisjes, Anjoke, Bemmel, Thomas van, Meir, Claudia A Van, Beld, Annewieke W van den, Hermes, W, Vidarsdottir, Solrun, Veldhuis-Vlug, Anneke G, Dullemond, Remke C, Jansen, Henrique J, Sueters, M, Koning, Eelco JP de, Laar, JOEH Judith van, Wouters-van Poppel, Pleun, Sanson-van Praag, Marina E, Akker, Eline S van den, Brouwer, Catherine B, Hermsen, Brenda B, Potter van Loon, Bert Jan, Heijden, Olivier WH van der, Galan, Bastiaan E de, Leeuwen, Marsha van, Wijbenga, Johanna AM, Boer, Karin de, Bon, Arianne C van, Made, Flip Van Der, Eskes, Silvia A, Zandstra, Mirjam, Houtum, William H van, Braams-Lisman, Babette AM, Daemen-Gubbels, Catharina RGM, Wouters, Maurice GAJ, Ijzerman, Richard G, Mensing van Charante, Nico A, Zwertbroek, Rolf, Bosmans, J E, Evers, Inge M, Mol, Ben WJ, Valk, Harold W de, Groenendaal, Floris, Naaktgeboren, Christiana, Painter, Rebecca C, Vries, J Hans de, Franx, Arie, Rijn, Bas B van |
| المصدر: |
ISSN:2044-6055. |
| بيانات النشر: |
BMJ Publishing Group |
| سنة النشر: |
2019 |
| المجموعة: |
Eindhoven University of Technology (TU/e): Research Portal |
| الوصف: |
Introduction In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. Methods The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. Ethics and dissemination The study protocol was approved by the Ethics Committee of the Utrecht University Medical ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| العلاقة: |
http://repository.tue.nl/913694Test |
| الإتاحة: |
http://repository.tue.nl/913694Test |
| حقوق: |
Copyright (c) Wit, Leon de ; Copyright (c) Rademaker, Doortje ; Copyright (c) Voormolen, Daphne N ; Copyright (c) Akerboom, Bettina MC ; Copyright (c) Kiewiet-Kemper, Rosalie M ; Copyright (c) Soeters, Maarten R ; Copyright (c) Verwij-Didden, Marion AL ; Copyright (c) Assouiki, Fahima ; Copyright (c) Schippers, D H ; Copyright (c) Vermeulen, Mechteld AR ; Copyright (c) Kuppens, SMI ; Copyright (c) Oosterwerff, Mirjam M ; Copyright (c) Zwart, Joost J ; Copyright (c) Diekman, Mattheus JM ; Copyright (c) Vogelvang, Tatjana E ; Copyright (c) Gallas, P Rob J ; Copyright (c) Galjaard, Sander ; Copyright (c) Visser, Willy ; Copyright (c) Horree, Nicole ; Copyright (c) Klooker, Tamira K ; Copyright (c) Laan, Rosemarie ; Copyright (c) Heijligenberg, Rik ; Copyright (c) Huisjes, Anjoke ; Copyright (c) Bemmel, Thomas van ; Copyright (c) Meir, Claudia A Van ; Copyright (c) Beld, Annewieke W van den ; Copyright (c) Hermes, W ; Copyright (c) Vidarsdottir, Solrun ; Copyright (c) Veldhuis-Vlug, Anneke G ; Copyright (c) Dullemond, Remke C ; Copyright (c) Jansen, Henrique J ; Copyright (c) Sueters, M ; Copyright (c) Koning, Eelco JP de ; Copyright (c) Laar, JOEH Judith van ; Copyright (c) Wouters-van Poppel, Pleun ; Copyright (c) Sanson-van Praag, Marina E ; Copyright (c) Akker, Eline S van den ; Copyright (c) Brouwer, Catherine B ; Copyright (c) Hermsen, Brenda B ; Copyright (c) Potter van Loon, Bert Jan ; Copyright (c) Heijden, Olivier WH van der ; Copyright (c) Galan, Bastiaan E de ; Copyright (c) Leeuwen, Marsha van ; Copyright (c) Wijbenga, Johanna AM ; Copyright (c) Boer, Karin de ; Copyright (c) Bon, Arianne C van ; Copyright (c) Made, Flip Van Der ; Copyright (c) Eskes, Silvia A ; Copyright (c) Zandstra, Mirjam ; Copyright (c) Houtum, William H van ; Copyright (c) Braams-Lisman, Babette AM ; Copyright (c) Daemen-Gubbels, Catharina RGM ; Copyright (c) Wouters, Maurice GAJ ; Copyright (c) Ijzerman, Richard G ; Copyright (c) Mensing van Charante, Nico A ; Copyright (c) Zwertbroek, Rolf ; Copyright (c) Bosmans, J E ; Copyright (c) Evers, Inge M ; Copyright (c) Mol, Ben WJ ; Copyright (c) Valk, Harold W de ; Copyright (c) Groenendaal, Floris ; Copyright (c) Naaktgeboren, Christiana ; Copyright (c) Painter, Rebecca C ; Copyright (c) Vries, J Hans de ; Copyright (c) Franx, Arie ; Copyright (c) Rijn, Bas B van |
| رقم الانضمام: |
edsbas.B754F888 |
| قاعدة البيانات: |
BASE |
