Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Diabetes Mellitus

Syndrome

Diabetes, Gestational

Polycystic Ovary Syndrome

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Hypoglycemic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Metformin

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

40 women will receive metformin in dose of 1500 mg per day orally (500 mg every 8 hrs in the middle of meal) starting from 12th week of gestation till delivery.

40 women will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.

Metformin group will receive 1500 mg of metformin per day orally ( 500 mg every 8hrs in the middle of meal) starting from 12th week of gestation till delivery.

metformin

placebo (folic acid )

Ahmed E elbohoty, MD

Ahmed E Elbohoty, Ph.D.

Reda k Mokhtar, MD

mai R ibrahim, MBBCH

Randomized, placebo controlled clinical trial that evaluate the role of taking metformin therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the development of gestational diabetes(GDM) and improving pregnancy outcomes.

The study will include a total of 80 pregnant women who fulfill the inclusion and exclusion criteria. Participants will be distributed into two groups :

Group A: Active one (40 women) will receive metformin in a dose of 1500mg per day (500mg every 8hrs in the middle of meal), starting from 12th week of gestation till delivery.

Group B: control group (40 women) will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.

80 opaque envelope will be numbered serially from 1-80, in each envelope paper containing the group to which the participants will be allocated according to randomization table .The envelopes will be put in one box and when the first patient arrives the first envelope will be open and the patient will be allocated according to the paper inside.

Detection of glucose intolerance will be done using oral glucose tolerance test (OGTT), which based on 75 gm to exclude any case of pre-gestational DM. BMI and blood pressure will be also assessed for all cases at entry of the study.

Follow up of all cases in antenatal care clinic, with clinical assessment including weight gain, blood pressure, urine examination for proteinuria and fetal well being tests.

Detection of development of GDM or even glucose intolerance will be by using (OGTT), which based on 75 gm glucose between 24th-28th wk and also can be repeated between 32th- 34th wk of pregnancy.

Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome

Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT )

Diagnosis of GDM when these values are met or exceed fasting plasma glucose level (92 mg/dl).1hr level is (180 mg/dl) and 2hrs level is (153 mg/dl).

Ain Shams University

Assistant professor of Obstetric and Gynecology Faculty of medicine Ain Shams University

Skin and Connective Tissue Diseases

Breast Neoplasms

Altered metabolic milieu is defined as a fasting glucose level \>100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels \> 92 mg/dL and/or plasma glucose levels \> 153 mg/dL two hours after load in the oral glucose tolerance test according to ADA guidelines or a fasting glucose \>100 mg/dL and/or \> 140 mg/dL two hours after load in the oral glucose tolerance test according to national guidelines. The COVID-19 pandemic is considered as a natural nutritional and mental health exposure.

Nutrition and mental health during pregnancy

María L Garmendia, PhD

Camila L Corvalán Aguilar, PhD

María F Mujica Coopman, PhD

The Chilean Maternal \& Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. In total, 1927 pregnant women beneficiaries of the public health systems and their offspring were recruited before 12 weeks of gestation and are followed across pregnancy (\<15, 26-28, and 35-37 weeks of gestation) and up to 2 years of age of their offspring. Two studies are currently nested in ChiMINCs II: 1) Breast Cancer Risk Assessment in Mothers (BRECAM) study, and 2) the ChiMINCs-COVID study. The primary objective of BRECAM study is to test the association between maternal metabolic indicators (i.e., insulin, glucose, IGF-1, and HbAc1 concentrations) at early pregnancy (i.e., \<15 and 26-28 weeks of gestation) and breast density 3 months after the cessation of lactation. For this purpose, we collect maternal obstetric, lifestyle, dietary intake, anthropometric, and biochemical information. The aim of the ChiMINCs-COVID study is to assess dietary-related risks and mental health problems derived from the COVID-19 pandemic and their influence on maternal and infant's health and nutrition. Thus, we collected detailed information on dietary behaviors, mental health and COVID-related information at each trimester, along with neonatal and infant nutritional information. The purpose of the present work is to describe the design, methods, and descriptive information at recruitment of ChiMINCs-II, also discussing the implications that this study can have to better understand maternal and infant nutrition and health during the COVID-19 era.

Additional fasting venous samples will be collected during routine public health care blood extractions and at delivery (maternal venous and umbilical cord blood samples). Also, feces samples of newborn will be collected after delivery. Whole blood, plasma, buffy coat, serum and red blood cells will be separated by centrifugation within the next 3 hours. Biological specimens will be aliquot and keep to -80ºC until the determination of metabolic markers, growth factors and hormones.

Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)

The Chilean Maternal and Infant Nutrition Cohort Study II

Data and blood samples that will be collected in this study will be under the custody of the principal investigator and a human subject protection review board will regulate its use. Others researchers may access the data by contacting to María Luisa Garmendia (Principal Investigator).

Pontificia Universidad Catolica de Chile

Servicio de Salud Metropolitano Sur Oriente

Instituto de Nutrición y Tecnología de los Alimentos

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome	NCT02802215	Polycystic Ovar... Diabetes, Gesta...	metformin placebo (folic ...	20 Years - 40 Years	Ain Shams University
Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)	NCT03920098	Breast Density Body Compositio... Nutritional Sta... Mental Health I...	Nutrition and m...	18 Years - 50 Years	Instituto de Nutrición y Tecnología de los Alimentos

Spots Global Cancer Trial Database for diabetes, gestational