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Glibenclamide effect on maternal and neonatal outcomes in women with gestational diabetes

Effect of glibenclamide in women with gestational diabetes on maternal and neonatal outcomes

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013102315045N2
Enrollment
278
Registered
2014-04-19
Start date
2013-03-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabet. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: 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 r
Treatment - Drugs
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
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 blo

Sponsors

Vice Chancellor for Research, Kashan University of Medical Sciences and Health Service
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Birth Mother Trauma. Timepoint: Immediately after delivery. Method of measurement: Observation.;Fetal anomaly. Timepoint: Immediately after delivery. Method of measurement: Observation.;APGAR score. Timepoint: APGAR score 1and 5 minute after birth. Method of measurement: Observation and examination.;Birthweight and birthweight percentiles. Timepoint: Immediately after delivery. Method of measurement: Scales and calculate percentile.;Blood Sugar. Timepoint: From one half hour up to 3 hours. Method of measurement: Blood test.;Blood calcium. Timepoint: One week after birth. Method of measurement: Blood test.;Neonatal icterus. Timepoint: One week after birth. Method of measurement: Blood sugar.;Shoulder dystocia. Timepoint: In the delivery room. Method of measurement: Observation.;Perinatal death. Timepoint: ?From the second half of gestation to 28 days after birth. Method of measurement: Follow the samples and study their documents.;Respiratory distress. Timepoint: Immediately to 4 hours after birth. Method of measurement: Observation and examination of newborn.;Method of delivery. Timepoint: Date of Birth. Method of measurement: Observation.;Birth Mother Trauma. Timepoint: During and after childbirth. Method of measurement: Observation.;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.;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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Tayebe Ghasemi

Kashan University of Medical Sciences, Faculty of Medicine

qasemi-ta@kaums.ac.ir+98 36 1555 0021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026