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Comparison of various protocoles for management of gestational diabetes

To compare the maternal, fetal and cost-effectiveness outcomes in 5 different screening strategies for gestational diabetes among pregnant women with = 14 weeks of gestation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT138707081281N1
Enrollment
39500
Registered
2017-02-15
Start date
2017-02-19
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 Diabetes. Diabetes mellitus arising in pregnancy

Interventions

Intervention 1: Protocol A: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will receive s
Treatment - Drugs
Protocol A: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will receive standard treatmen
Protocol B: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard trea
Protocol C: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard trea
Protocol D: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will receive standard treatmen
Protocol E: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard trea

Sponsors

National institute for medical research development
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All 1st trimester pregnant women who refer from health centers of selected cities among 5 provinces will recruit to the study Exclusion criteria: Preexisting diabetes; Prior gestational diabetes; A history of stillbirth; Multifetal gestation; Asthma; Chronic hypertension; Taking corticosteroids

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Cost of health services including pregnancy, delivery and neonatal period. Timepoint: After expenses in each phase. Method of measurement: View, record and receive expenses factors.;Quality-adjusted life years (QALYs). Timepoint: pregnancy, delivery and neonatal period. Method of measurement: Quality-adjusted life years (QALYs).;Percentage of birth weight>90th percentile. Timepoint: at the time of delivery. Method of measurement: Using fetal growth curves.;Percentage of primary cesarean section. Timepoint: at the time of delivery. Method of measurement: View and registered cases of primary cesarean.;Percentage of neonatal hypoglycemia. Timepoint: At first hour after birth. Method of measurement: Measurment the blood glucose levels using a laboratory glucose kit.

Secondary

MeasureTime frame
Percentage of birth weight<10th percentile. Timepoint: After delivery. Method of measurement: Using fetal growth curves.;The percentage of admission to the neonatal intensive care unit. Timepoint: neonatal period (T the time of birth until day 28 after birth). Method of measurement: Observation and record.;Birth trauma including fracture of clavicle, brachial plexus injury. Timepoint: At the time of delivery. Method of measurement: Observation and record.;Still birth(intra uterine death). Timepoint: delivery. Method of measurement: delivery registry.;Preeclampsia. Timepoint: 2nd and 3rd trimesters. Method of measurement: prenatal records.;Preterm labor. Timepoint: delivery. Method of measurement: delivery registry.;Shoulder dystocia. Timepoint: delivery. Method of measurement: delivery registry.;Neonatal hyperbilirubinemia. Timepoint: neonatal period. Method of measurement: blood bilirubine.;Neonatal hypocalcaemia. Timepoint: neonatal period. Method of measurement: blood calcium.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh Ramezani Tehrani

Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences Shahid Behesht

ramezani@endocrine.ac.ir+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 1, 2026