Protocol summary

Summary
Due to the importance of treatment of gestational diabetes, the research will be conducted to assess the effect of maternal and neonatal outcomes in gestational diabetes treated with glibenclamide. 278 pregnant women with singleton pregnancies and no history of diabetes, at 33 -11 weeks of gestation will be enrolled and randomly assigned to two groups and 139 eligible women in any glibenclamide and insulin groups. Exclusion criteria included cardiovascular disease, hematological disease, renal or liver disease, severe infectious disease, acute respiratory failure and premature rupture of membrane. Patients will take glibenclamide or routine treatment (insulin) to level of fasting blood glucose and two hours after meals reach less than 90 and 120 respectively. After sampling, fetal Apgar at 1 and 5 minutes, percentile of newborn birth weight, blood sugar three hours after birth, calcium, incidence of hyperbilirubinemia, macrosomia, intrauterine growth restriction, shoulder dystocia, perinatal mortality and morbidity, respiratory distress, need to be admitted to the neonatal intensive care unit in new born, preeclampsia, birth trauma and hypoglycaemia in women will be compared in insulin and glibenclamide intervention group by statistical analysis techniques.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102315045N2
Registration date: 2014-04-19, 1393/01/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Tayebe Ghasemi
Name of organization / entity
University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3775 0271
Email address
qasemi-ta@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Voice Chancellor for Research, Kashan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of glibenclamide in women with gestational diabetes on maternal and neonatal outcomes
Public title
Glibenclamide effect on maternal and neonatal outcomes in women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female age between 18 to 45 years; singleton pregnancy; no history of diabetes before pregnancy; gestational age between 11-33 weeks Exclusion criteria: premature rupture of membrane; severe infectious diseases; cardiovascular diseases; acute respiratory failure; hematological disease; renal disease; liver disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 278
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences, vice chancellor for reaserch
Street address
5th of Qotb5th of Qotb –e Ravandi Blvd., Kashan, IRAN
City
Kashan
Postal code
8715988141
Approval date
2013-08-26, 1392/06/04
Ethics committee reference number
29/5/2065/پ

Health conditions studied

1

Description of health condition studied
Gestational diabet
ICD-10 code
024.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
Birth Mother Trauma
Timepoint
Immediately after delivery
Method of measurement
Observation

2

Description
Fetal anomaly
Timepoint
Immediately after delivery
Method of measurement
Observation

3

Description
APGAR score
Timepoint
APGAR score 1and 5 minute after birth
Method of measurement
Observation and examination

4

Description
Birthweight and birthweight percentiles
Timepoint
Immediately after delivery
Method of measurement
Scales and calculate percentile

5

Description
Blood Sugar
Timepoint
From one half hour up to 3 hours
Method of measurement
Blood test

6

Description
Blood calcium
Timepoint
One week after birth
Method of measurement
Blood test

7

Description
Neonatal icterus
Timepoint
One week after birth
Method of measurement
Blood sugar

8

Description
Shoulder dystocia
Timepoint
In the delivery room
Method of measurement
Observation

9

Description
Perinatal death
Timepoint
ّFrom the second half of gestation to 28 days after birth
Method of measurement
Follow the samples and study their documents

10

Description
Respiratory distress
Timepoint
Immediately to 4 hours after birth
Method of measurement
Observation and examination of newborn

11

Description
Method of delivery
Timepoint
Date of Birth
Method of measurement
Observation

12

Description
Birth Mother Trauma
Timepoint
During and after childbirth
Method of measurement
Observation

13

Description
Maternal hypoglycemia
Timepoint
Once every three days until it becomes normal and then 4 times a day every week until delivery
Method of measurement
Blood glucose testing in the Shabih Khani hospital laboratory

14

Description
Preeclapsia
Timepoint
ّFrom the second half of pregnancy up to 24 hours after birth
Method of measurement
Blood pressure measurement, urinalysis, and clinical symptoms examination

Secondary outcomes

1

Description
Need to be admitted to the neonatal intensive care unit.
Timepoint
From birth until one week after delivery
Method of measurement
Follow up with the call and physical exam in infants hospitalized

Intervention groups

1

Description
In the glibenclamide group, patients will take 1.25 mg oral tablet glibenclamid, once daily and If need, it will increase three days to reach the maximum daily 20 mg.If glibenclamide reach to maximum dose and after 2 weeks, the blood sugar level was not normal, the patient will be treated with insulin.
Category
Treatment - Drugs

2

Description
In insulin group, treated will be start with 0.2 U/kg insulin twice daily injections subcutaneously. If needed, it will increase every 3 days to achieve normal levels of blood sugar. The patient's blood sugar will be measured 4 times daily (fasting, 2 hours after breakfast, two hours after lunch and 2 hours after dinner).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Doctor Shbih Khani Hospital
Full name of responsible person
Street address
City
Kashan

2

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kashan University of Medical Sciences and Health Service
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th of Qotb –e Ravandi Blvd. P.O., Kashan, IRAN
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kashan University of Medical Sciences and Health Service
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences, Faculty of Medicine
Full name of responsible person
Dr.Tayebe Ghasemi
Position
Assistant in obstetrics and gynecology
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd. P.O., Kashan, IRAN
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
Email
qasemi-ta@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mitra Behrashi
Position
Gynecologist. Associate professor
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd. P.O., Kashan, IRAN
City
Kashan
Postal code
8715988141
Phone
+98 36 1446 0180
Fax
Email
َAR-behrashi2006@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences, Faculty of Medicine
Full name of responsible person
Dr. Mitra Behrashi
Position
Gynecologist, Associate professor
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd. , Kashan, IRAN
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
Email
AR-behrashi2006@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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