scholarly journals Prophylactic metformin after antenatal corticosteroids (PROMAC): a double blind randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jesrine Gek Shan Hong ◽  
Peng Chiong Tan ◽  
Maherah Kamarudin ◽  
Siti Zawiah Omar
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Blood Sugar ◽  
Controlled Trial ◽  
Common Adverse Effect ◽  
Study Drug ◽  
Normal Pregnancy ◽  
Antenatal Corticosteroids ◽  
Double Blind ◽  
Maternal Hyperglycemia

Abstract Background Antenatal corticosteroids (ACS) are increasingly used to improve prematurity-related neonatal outcome. A recognized and common adverse effect from administration of antenatal corticosteroid is maternal hyperglycemia. Even normal pregnancy is characterized by relative insulin resistance and glucose intolerance. Treatment of maternal hyperglycemia after ACS might be indicated due to the higher risk of neonatal acidosis which may coincide with premature birth. Metformin is increasingly used to manage diabetes mellitus during pregnancy as it is effective and more patient friendly. There is no data on prophylactic metformin to maintain euglycemia following antenatal corticosteroids administration. Methods A double blind randomized trial. 103 women scheduled to receive two doses of 12-mg intramuscular dexamethasone 12-hour apart were separately randomized to take prophylactic metformin or placebo after stratification according to their gestational diabetes (GDM) status. First oral dose of allocated study drug was taken at enrolment and continued 500 mg twice daily for 72 hours if not delivered. Six-point blood sugar profiles were obtained each day (pre- and two-hour post breakfast, lunch and dinner) for up to three consecutive days. A hyperglycemic episode is defined as capillary glucose fasting/pre-meal ≥ 5.3 mmol/L or two-hour post prandial/meal ≥ 6.7 mmol/L. Primary outcome was hyperglycemic episodes on Day-1 (first six blood sugar profile points) following antenatal corticosteroids. Results Number of hyperglycemic episodes on the first day were not significantly different (mean ± standard deviation) 3.9 ± 1.4 (metformin) vs. 4.1 ± 1.6 (placebo) p = 0.64. Hyperglycemic episodes markedly reduced on second day in both arms to 0.9 ± 1.0 (metformin) vs. 1.2 ± 1.0 (placebo) p = 0.15 and further reduced to 0.6 ± 1.0 (metformin) vs. 0.7 ± 1.0 (placebo) p = 0.67 on third day. Hypoglycemic episodes during the 3-day study period were few and all other secondary outcomes were not significantly different. Conclusions In euglycemic and diet controllable gestational diabetes mellitus women, antenatal corticosteroids cause sustained maternal hyperglycemia only on Day-1. The magnitude of Day-1 hyperglycemia is generally low. Prophylactic metformin does not reduce antenatal corticosteroids’ hyperglycemic effect. Trial registration The trial is registered in the ISRCTN registry on May 4 2017 with trial identifier 10.1186/ISRCTN10156101.

scholarly journals Effect of antenatal dietary myo-inositol supplementation on the incidence of gestational diabetes mellitus and fetal outcome: protocol for a double-blind randomised controlled trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055314
Author(s):  
Ibrahim Ibrahim ◽  
Hala Abdullahi ◽  
Yassin Fagier ◽  
Osman Ortashi ◽  
Annalisa Terrangera ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Dietary Advice ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Double Blind ◽  
Registration Number

IntroductionGestational diabetes mellitus (GDM) affects 23.6% of Qatari women and is associated with maternal and perinatal morbidity and long-term risk of developing type 2 diabetes. A number of challenges exist with current interventions, including non-compliance with dietary advice, the reluctance of mothers to ingest metformin tablets or use insulin injections. These challenges highlight the importance of pursuing evidence-based prevention strategies. Myo-inositol is readily available as an US Food and Drug Administration-approved food supplement with emerging but limited evidence suggesting it may be beneficial in reducing the incidence of GDM. Further studies, such as this one, from different ethnic contexts and with differing risk factors, are urgently needed to assess myo-inositol effects on maternal and neonatal outcomes.Methods and analysisThis study is a prospective, randomised, double-blinded, placebo controlled clinical trial to either myo-inositol supplementation or placebo.We plan to enrol 640 pregnant women attending antenatal care at Sidra Medicine, Doha, Qatar, 320 in each arm. All participants will complete at least 12 weeks of supplementation prior to undertaking the Oral Glucose Tolerance Test at 24–28 weeks. The daily use of the trial supplementation will continue until the end of pregnancy. All outcome measures will be collected from the electronic medical records.Ethics and disseminationEthical approval for the study was obtained on 12 April 2021 from Sidra Medicine (IRB number 1538656). Results of the primary trial outcome and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberProspectively registered on 26 May 2021. Registration number ISRCTN16448440 (ISRCTN registry).

scholarly journals Assessment of the understanding of informed consent including participants’ experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research

2018 ◽  
Vol 1 ◽  
pp. 12 ◽  
Author(s):  
Shubham Atal ◽  
Fidelma Dunne
Keyword(s):  
Diabetes Mellitus ◽  
Informed Consent ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Pregnant Women ◽  
Decision Aid ◽  
Controlled Trial ◽  
Study Drug ◽  
University Hospital ◽  
Microsoft Office

Background: Informed consent is a basic ethical requirement of clinical research, yet deficiencies have been documented in the comprehension of its components among trial participants. Pregnancy research is sparsely conducted. Assessment of understanding of the informed consent among pregnant women suffering from Gestational Diabetes Mellitus enrolled in a randomized controlled trial, and their experiences was planned. Methodology: A prospective observational cohort study was conducted among participants of EMERGE clinical trial at the University Hospital, Galway. Willing participants allowed observation of their consent encounters. They completed the standard QuIC questionnaire at follow up visits for assessment of objective and subjective understanding of informed consent, and reasons to participate and level of satisfaction. Data was entered and analysed using Microsoft Office Excel and Minitab version 18. Results: The most commonly asked questions asked in the twenty consent encounters observed were focused upon the safety of the study drug for the developing foetuses and women. The general attitude of the women was positive towards participation. The mean objective understanding score was 72.43 ± 7 and the subjective understanding score was 91.67 ± 8.68 (out of 100). Critical components of consent like voluntarism, randomisation, withdrawal, and benefit to others were well understood. The domains related to nonstandard nature of treatment, additional risks/discomforts and compensation were poorly understood. The women cited the desire to provide benefit to future patients as the most common reason to participate, and most were satisfied with the consent process. Conclusion: Comprehension of informed consent is good in most aspects, but the grasp of certain concepts is poor among the pregnant women. Efforts are needed to improve informed consent through engagement of investigators, research nurses and possibly, the use of a decision aid.

scholarly journals Health Care Professionals� Attitudes Toward, and Experiences of Using, a Culture-Sensitive Smartphone App for Women with Gestational Diabetes Mellitus: Qualitative Study (Preprint)

2017 ◽  
Author(s):  
Lisa Garnweidner-Holme ◽  
Therese Hoel Andersen ◽  
Mari Wastvedt Sando ◽  
Josef Noll ◽  
Mirjam Lukasse
Keyword(s):  
Diabetes Mellitus ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Blood Sugar ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Technical Problems ◽  
Randomized Controlled

BACKGROUND The increasing prevalence of gestational diabetes mellitus (GDM) among women of different ethnic backgrounds provides new challenges for health care professionals, who often find it difficult to provide information about the management of this disease to such individuals. Mobile health (mHealth) may act as a useful tool for blood sugar control and care process enhancement. However, little is known about health care professionals’ experiences and attitudes toward the use of mHealth for women with GDM. OBJECTIVE The aim of this study was to explore how health care professionals perceived the provision of care to pregnant women who managed their GDM using the culture-sensitive Pregnant+ app in a randomized controlled trial. METHODS Individual interviews with 9 health care professionals providing care for women with GDM were conducted. Braun and Clark’s method of thematic content analysis inspired the analysis. This study included health care professionals who were primarily responsible for providing care to participants with GDM in the Pregnant+ randomized controlled trial at 5 diabetes outpatient clinics in Oslo, Norway. RESULTS Health care professionals perceived mHealth, particularly the Pregnant+ app, as an appropriate tool for the care of women with GDM, who were described as individuals comprising a heterogeneous, motivated group that could be easily approached with health-related information. Some participants reported challenges with respect to provision of advice to women with different food cultures. The advantages of the Pregnant+ app included provision of information that women could access at home, the information provided being perceived as trustworthy by health care professionals, the culture sensitivity of the app, and the convenience for women to register blood sugar levels. Technical problems, particularly those associated with the automatic transfer of blood glucose measurements, were identified as the main barrier to the use of the Pregnant+ app. Strict inclusion criteria and the inclusion of participants who could not speak Norwegian were the main challenges in the recruitment process for the randomized controlled trial. CONCLUSIONS The findings of this study suggest that mHealth is a useful tool to enhance the care provided by health care professionals to women with GDM. Future mobile apps for the management of GDM should be developed by a trustworthy source and in cooperation with health care professionals. They should also be culture sensitive and should not exhibit technical problems.

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