Skip to main content
OpenTrials
Completed

NCT Number: NCT02355197

Antioxidants in Gestational Diabetes

Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32 weeks and high blood sugar levels were found so Cases were controlled by both diet and insulin.

The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet & insulin). Group2 received only the treatment of diabetes

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

About this study

The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid oral once daily (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet & insulin). Group2 received only the treatment of diabetes (diet and insulin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with the diagnosis of GDM

Exclusion criteria

  • Women with multiple pregnancies
  • Chronic medical disorders e.g. anemia
  • Hypertension
  • Liver disease or renal disease
  • Those with obstetric problems other than GDM (e.g. pre-eclampsia & antepartum hemorrhage) or smokers and women with preexisting type I or II diabetes mellitus were excluded from our study

Treatment and study plan

L-ascorbic acid

Drug

1 gram L-ascorbic acid (vitamin C …..) per day from the time of diagnosis until the time of delivery

Other names: vitamin C

Primary outcomes

  1. neonatal outcome assessed by neonatal ICU admission

    Time frame: 1 week after delivery

Secondary outcomes

  1. oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in placental tissue homogenates in women with GDM named glutathione ,malondialdahyde,superoxide dismutase ,catalase and glutathione peroxidase

    Time frame: 9 months of pregnancy

  2. oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in maternal blood plasma/lysate in women with GDM named glutathione,superoxide dismutase ,catalase and glutathione peroxidase

    Time frame: 9 months of pregnancy

  3. oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in neonatal blood in women with GDM named malondialdahyde and superoxide dismutase

    Time frame: 9 months of pregnancy

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Physiological Effects of Gestational Diabetes on the Placenta and Neonatal Outcome; Role of Antioxidant Administration

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2015
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.