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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02355197
Other study ID # 124
Secondary ID
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
Health authority
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

Study Design


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
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