An observational study in Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, sponsored by Hanoi Medical University. Not yet recruiting at 3 sites in Vietnam. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Hanoi Medical University · Observational
This study will compare maternal blood glucose and cortisol responses and neonatal outcomes between women with gestational diabetes mellitus and women without gestational diabetes mellitus who receive epidural analgesia during labor. The study will be conducted at three hospitals in Hanoi, Vietnam. Maternal blood glucose will be measured repeatedly during labor, and cortisol will be measured before epidural analgesia and 2 hours later. Neonatal assessments will include umbilical cord arterial blood gas analysis, blood glucose measurements after birth, and clinical outcomes. Other maternal factors, including body temperature and labor course, will also be recorded.
This prospective, multicenter, observational comparative study will enroll atleast 126 term parturients planning vaginal delivery at Hanoi Medical University Hospital, Hanoi Obstetrics and Gynecology Hospital, and Bach Mai Hospital. Participants will be enrolled into two cohorts according to their gestational diabetes mellitus status: women with gestational diabetes mellitus A1 managed without insulin during labor and women without gestational diabetes mellitus. All participants will receive standardized epidural labor analgesia as part of routine clinical care.The primary maternal outcome is the area under the curve of maternal capillary blood glucose concentrations measured hourly from before epidural analgesia until completion of the third stage of labor. Maternal plasma cortisol will be measured before epidural analgesia and 2 hours after its initiation.Neonatal outcomes will include umbilical cord arterial blood gas values obtained immediately after delivery, blood glucose measured at birth and 1 hour after birth, Apgar scores, respiratory support, neonatal intensive care unit admission, jaundice, and symptomatic hypoglycemia.Other maternal factors will also be recorded, including body temperature and intrapartum fever, glucose variability, hypoglycemia and hyperglycemia, labor duration and course, mode of delivery, oxytocin use, hypotension, epidural analgesic dose, and oral intake during labor. Participants who undergo intrapartum cesarean delivery after enrollment will discontinue the study-specific intrapartum assessment and will be excluded from the primary analysis, in accordance with the approved protocol. The occurrence and indication for cesarean delivery will be recorded.
Hanoi Medical University is the lead sponsor of 53 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population comprises term parturients aged 18 to 40 years with a singleton, cephalic pregnancy who plan vaginal delivery and request epidural labor analgesia at Hanoi Medical University Hospital, Bach Mai Hospital, or Hanoi Obstetrics and Gynecology Hospital. Participants will include women with diet-controlled gestational diabetes mellitus A1 and women without gestational diabetes mellitus.
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Age 18 to 40 years.
Pre-existing type 1 or type 2 diabetes mellitus, or gestational diabetes mellitus requiring insulin treatment.
Term parturients with gestational diabetes mellitus A1, managed without insulin during labor, who plan vaginal delivery and receive standardized epidural labor analgesia.
Term parturients without gestational diabetes mellitus who plan vaginal delivery and receive standardized epidural labor analgesia.
Area under the curve of maternal capillary blood glucose concentration
Maternal capillary blood glucose concentrations will be measured hourly from baseline before epidural analgesia until completion of the third stage of labor. The area under the concentration-time curve will be calculated and compared between women with gestational diabetes mellitus A1 and women without gestational diabetes mellitus.
Time frame: At baseline immediately before epidural analgesia and every hour thereafter until delivery of the placenta.
Maternal blood glucose variability and dysglycemic events
Maternal blood glucose variability, hypoglycemia, and hyperglycemia will be assessed from hourly capillary blood glucose measurements during labor.
Time frame: At baseline immediately before epidural analgesia and every hour thereafter until delivery of the placenta
Maternal plasma cortisol change
Change in maternal plasma cortisol concentration will be calculated as the concentration at 2 hours after initiation of epidural analgesia minus the baseline concentration measured immediately before epidural analgesia. The change, expressed in nmol/L, will be compared between the gestational diabetes and non-diabetes cohorts.
Time frame: Immediately before epidural analgesia and 2 hours after its initiation
Labor and delivery characteristics
Labor duration, labor course, mode of delivery, and oxytocin use will be recorded and compared between cohorts.
Time frame: From initiation of epidural analgesia until delivery of the placenta.
Maternal intrapartum adverse events
Maternal hypotension and other recorded adverse events related to labor or epidural analgesia will be assessed and compared between cohorts.
Time frame: From initiation of epidural analgesia until delivery of the placenta.
Change in maternal body temperature
Maternal body temperature will be recorded in degrees Celsius immediately before epidural analgesia and hourly during labor until birth. Change from baseline will be calculated at each subsequent measurement and compared between cohorts.
Time frame: At baseline immediately before epidural analgesia and every hour thereafter until birth.
Incidence of intrapartum fever
The number and percentage of participants with at least one valid tympanic temperature measurement of 38.0 degrees Celsius or higher after initiation of epidural analgesia and before birth will be compared between cohorts.
Time frame: From initiation of epidural analgesia until birth.
Umbilical arterial blood pH
Umbilical arterial blood pH will be measured in a cord blood sample collected immediately after birth and compared between cohorts. pH is dimensionless.
Time frame: Immediately after birth.
Umbilical arterial partial pressure of carbon dioxide
The partial pressure of carbon dioxide in umbilical arterial blood will be measured in mmHg in a cord blood sample collected immediately after birth and compared between cohorts.
Time frame: Immediately after birth.
Umbilical arterial partial pressure of oxygen
The partial pressure of oxygen in umbilical arterial blood will be measured in mmHg in a cord blood sample collected immediately after birth and compared between cohorts.
Time frame: Immediately after birth
Umbilical arterial base excess
Umbilical arterial base excess will be measured in mmol/L in a cord blood sample collected immediately after birth and compared between cohorts.
Time frame: Immediately after birth
Umbilical arterial lactate concentration
Umbilical arterial lactate concentration will be measured in mmol/L in a cord blood sample collected immediately after birth and compared between cohorts.
Time frame: Immediately after birth
Apgar score
Apgar scores will be recorded at 1, 3 and 5 minutes after birth and compared between cohorts at each time point. Scores range from 0 to 10, with higher scores indicating better neonatal condition.
Time frame: At 1, 3 and 5 minutes after birth
Neonatal respiratory support
The number and percentage of newborns requiring respiratory support during the first 48 hours after birth will be reported for each cohort. The type of respiratory support provided will be recorded.
Time frame: From birth through 48 hours after birth
Neonatal intensive care unit admission
The number and percentage of newborns admitted to a neonatal intensive care unit during the first 48 hours after birth will be compared between cohorts.
Time frame: From birth through 48 hours after birth
Neonatal jaundice
The number and percentage of newborns with clinically diagnosed jaundice documented during the first 48 hours after birth will be compared between cohorts.
Time frame: From birth through 48 hours after birth.
Symptomatic neonatal hypoglycemia
The number and percentage of newborns with at least one episode of symptomatic hypoglycemia during the first 48 hours after birth will be compared between cohorts. An episode is defined as a blood glucose concentration below 2.6 mmol/L measured at the time of compatible clinical signs, such as jitteriness, poor feeding, lethargy, hypotonia, apnea, or seizures, and documented by the treating neonatal clinician. Clinically indicated glucose measurements during this period will be used to identify episodes.
Time frame: From birth through 48 hours after birth.
Neonatal heel-prick capillary blood glucose concentration
Neonatal capillary blood glucose concentration, expressed in mmol/L, will be measured using heel-prick samples immediately after birth and at 1 hour after birth. Glucose concentrations will be compared between the gestational diabetes and non-diabetes cohorts separately at each time point.
Time frame: Immediately after birth and at 1 hour after birth.
Plan to share: No — Individual participant data will not be shared because the current study protocol and informed consent materials do not include provisions for secondary data sharing. The dataset contains sensitive maternal and neonatal clinical information, and the sample size is limited. Any future data-sharing plan would require appropriate de-identification, institutional approval, and, where applicable, amendment of the informed consent and ethics approval.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hanoi Medical University