Antioxidants in Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355197
• Other study ID #: 124
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2015
• Last updated: March 22, 2017
• Start date: January 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neonatal outcome assessed by neonatal ICU admission		1 week after delivery
Secondary	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		9 months of pregnancy
Secondary	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		9 months of pregnancy
Secondary	oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in neonatal blood in women with GDM named malondialdahyde and superoxide dismutase		9 months of pregnancy