NCT06111157 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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L. Kitzmiller, A. Ferrara, T. Peng, M. A. Cissell, and C. Kim, "Chapter 5: Preexisting Diabetes and Pregnancy."
Akbariasbagh P, Shariat M, Akbariasbagh N, Ebrahim B
Cardiovascular Malformations in Infants of Diabetic Mothers: A Retrospective Case-Control Study. Acta Med Iran. 2017 Feb;55(2):103-108.
Kc K, Shakya S, Zhang H
Gestational diabetes mellitus and macrosomia: a literature review. Ann Nutr Metab. 2015;66 Suppl 2:14-20. doi: 10.1159/000371628. Epub 2015 Jun 2.
Malaza N, Masete M, Adam S, Dias S, Nyawo T, Pheiffer C
A Systematic Review to Compare Adverse Pregnancy Outcomes in Women with Pregestational Diabetes and Gestational Diabetes. Int J Environ Res Public Health. 2022 Aug 31;19(17):10846. doi: 10.3390/ijerph191710846.
Ornoy A, Becker M, Weinstein-Fudim L, Ergaz Z
Diabetes during Pregnancy: A Maternal Disease Complicating the Course of Pregnancy with Long-Term Deleterious Effects on the Offspring. A Clinical Review. Int J Mol Sci. 2021 Mar 15;22(6):2965. doi: 10.3390/ijms22062965.
Singh S, Yadav M
Gestational Diabetes Mellitus among Pregnant Women Delivering in a Tertiary Care Hospital: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2022 Mar 11;60(247):229-233. doi: 10.31729/jnma.7304.
Weintrob N, Karp M, Hod M
Short- and long-range complications in offspring of diabetic mothers. J Diabetes Complications. 1996 Sep-Oct;10(5):294-301. doi: 10.1016/1056-8727(95)00080-1.

Clinical Spectrum of Infants of Diabetic Mothers , in Neonatal Intensive Care Unit of Assiut University Children's Hospital

Clinical trial NCT06111157 - References