Congenital Abnormalities — Congenital Anomalies in Infants of Diabetic Mother
Citation(s)
Aberg A, Westbom L, Källén B Congenital malformations among infants whose mothers had gestational diabetes or preexisting diabetes. Early Hum Dev. 2001 Mar;61(2):85-95.
Ameen, S K., Alalaf, S.K. & Shabila, N.P. Pattern of congenital anomalies at birth and their correlations with maternal characteristics in the maternity teaching hospital, Erbil city, Iraq. BMC Pregnancy Childbirth.(2018),18, 501 . https://doi.org/10.1186/s12884-018-2141-2
Anyanwu LJC, Danborno B, Hamman WO Birth prevalence of overt congenital anomalies in Kano Metropolis: overt congenital anomalies in the Kano. Uni J Pub Health. 2015;3(2):89-96.
Gabbay-Benziv R, Reece EA, Wang F, Yang P Birth defects in pregestational diabetes: Defect range, glycemic threshold and pathogenesis. World J Diabetes. 2015 Apr 15;6(3):481-8. doi: 10.4239/wjd.v6.i3.481. Review.
Nasri HZ, Houde Ng K, Westgate MN, Hunt AT, Holmes LB Malformations among infants of mothers with insulin-dependent diabetes: Is there a recognizable pattern of abnormalities? Birth Defects Res. 2018 Jan;110(2):108-113. doi: 10.1002/bdr2.1155.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
