Comparison of universal screening for gestational diabetes mellitus between one-step and two-step method among Thai pregnant women: A randomized control trial
- Conditions
- The primary outcome was the prevalence of GDM. Secondary outcomes included both maternal and fetal outcomes associated with GDM. Maternal outcomes included mode of delivery, preterm labor, preeclampsia, eclampsia, cesarean section, postpartum hemorrhage, and perineal injuries. Fetal outcomes included birth weight, birth injuries, Apgar scores, neonatal hypoglycemia, hyperbilirubinemia, and the need for intensive neonatal care.Gestational diabetes mellitus, Glucose tolerance test, Pregnancy, Universal screening
- Registration Number
- TCTR20240805007
- Lead Sponsor
- Endowment fund, Faculty of Medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 122
The inclusion criteria were as follows: 1) singleton pregnancy, 2) no prior diagnosis of overt or pre-gestational diabetes mellitus, and 3) gestational age between 18 weeks and 23+6 weeks, based on accurate and regular menstrual bleeding, along with sonographic fetal biometry in the first half of pregnancy (crown-rump length or biparietal diameter)
1) Pregnant women with HbA1C levels greater than or equal to 6.5% at the time of study enrollment.
2) Pregnant women in the one-step approach group with fasting glucose levels greater than or equal to 126 mg/dL.
3) Pregnant women who are unable or do not attend scheduled antenatal visits for screening and diagnosis of gestational diabetes between 24-28 weeks of gestation.
4) Pregnant women who choose to withdraw from the study.
5) Pregnant women who experience severe vomiting or significant adverse effects from ingesting glucose or from blood draws, rendering them unable to continue with the screening and diagnosis of gestational diabetes.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of GDM At time of delivery Number of patient and percentage
- Secondary Outcome Measures
Name Time Method Gestational age at delivery At time of delivery Mean of Gestational age at delivery (weeks),Mode of delivery At time of delivery Number and percentage of Normal delivery, Forceps delivery, Vacuum delivery and Cesarean delivery,Estimate blood loss At time of delivery ml,Obstetric complications At time of delivery Number and percentage of Pre-eclampsia, Birth trauma, Fetal-non reassuring, and Postpartum hemorrhage,Birthweight At time of delivery grams,Low Apgar scores (less than 7 at 5 minutes) At time of delivery Number and percentage,Fetal macrosomia At time of delivery Number and percentage,Neonatal complications (respiratory distress, hypoglycemia, hyperbilirubinemia requiring phototherapy, birth injury, and NICU care) At time of delivery Number and percentage