Gestational Diabetes Mellitus in Pregnancy, Diet- ControlledNCT07870629
Maternal Glucose, Cortisol, and Neonatal Outcomes With and Without GDM
An observational study of Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, run by Hanoi Medical University at 3 sites in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
- How many people
- 126 participants
- Where
- 3 sitesVietnam
- Study dates
- Oct 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Age 18 to 40 years.
- Singleton pregnancy with cephalic presentation and gestational age 37 to 42 weeks.
- Planned vaginal delivery.
- Cervical dilatation of 3 to 4 cm at epidural catheter placement.
- American Society of Anesthesiologists physical status I or II.
- Request for and written informed consent to epidural labor analgesia and study participation.
- Gestational diabetes mellitus group: gestational diabetes mellitus diagnosed using a 75-g, 2-hour oral glucose tolerance test according to national guidance and managed with diet and exercise without insulin during labor.
- Non-gestational diabetes mellitus group: negative 75-g, 2-hour oral glucose tolerance test during the same pregnancy.
Who cannot join
- Pre-existing type 1 or type 2 diabetes mellitus, or gestational diabetes mellitus requiring insulin treatment.
- Endocrine disorders that affect cortisol or glucose metabolism, including Cushing syndrome or adrenal insufficiency.
- Severe preeclampsia or eclampsia; complete placenta previa; previous uterine scar; threatened uterine rupture; fetal growth restriction; or severe polyhydramnios or oligohydramnios.
- Severe or decompensated medical disease.
- Systemic corticosteroid use, with the most recent dose administered within 72 hours before labor.
- Contraindication to epidural analgesia or refusal of the procedure.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam3 sites
Bach Mai Hospital
Hanoi, Hà Nội - Hanoi City, 10000
Toàn Thắng Nguyễn, Ass.Prof, PhD., +84916874795, nguyentoanthang@hmu.edu.vn
Hanoi Medical University Hospital
Hanoi, Hà Nội - Hanoi City, 10000
Hữu Tú Nguyễn, Prof. PhD., +84904176397, nguyenhuutu@hmu.edu.vn
Quang Minh Phạm, Ass.Prof. PhD., +84973183767, quangminhvietduc@yahoo.com
Hanoi Obstetrics and Gynecology Hospital
Hanoi, Hà Nội - Hanoi City, 10000
Đức Lam Nguyễn, Ass.Prof, PhD., 0367378519 ext. +84904220301, nguyenduclam@hmu.edu.vn
About this study
Official title: A Prospective Observational Comparative Study of Maternal Glycemic and Cortisol Responses and Neonatal Outcomes During Epidural Labor Analgesia in Women With and Without Gestational Diabetes Mellitus
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.
Read the detailed description
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.
- Keywords
- Epidural analgesia, Labor analgesia, Maternal blood glucose, Maternal cortisol, Maternal body temperature, Neonatal outcomes, Intrapartum fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes mellitus A1 | Term parturients with gestational diabetes mellitus A1, managed without insulin during labor, who plan vaginal delivery and receive standardized epidural labor analgesia. | |
| No gestational diabetes mellitus | Term parturients without gestational diabetes mellitus who plan vaginal delivery and receive standardized epidural labor analgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline immediately before epidural analgesia and every hour thereafter until delivery of the placenta.
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after birth and at 1 hour after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in Pregnancy, Diet- ControlledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Bach Mai Hospital, Hanoi Obstetrics and Gynecology Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870629
- Sponsor's protocol ID
- HMU-ELA-GDM-NEO-2026
- Other IDs
- TCTR20260710003
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Comparative Study of Maternal Glycemic and Cortisol Responses and Neonatal Outcomes During Epidural Labor Analgesia in Women With and Without Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07870629
- Acronym / sponsor ID
- HMU-ELA-GDM-NEO-2026
- Keywords
- Epidural analgesia, Labor analgesia, Maternal blood glucose, Maternal cortisol, Maternal body temperature, Neonatal outcomes, Intrapartum fever
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- Bach Mai Hospital, Hanoi Obstetrics and Gynecology Hospital
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes mellitus A1 | – | –Term parturients with gestational diabetes mellitus A1, managed without insulin during labor, who plan vaginal delivery and receive standardized epidural labor analgesia. |
| No gestational diabetes mellitus | – | –Term parturients without gestational diabetes mellitus who plan vaginal delivery and receive standardized epidural labor analgesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (8 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the curve of maternal capillary blood glucose concentration
Time frame: At baseline immediately before epidural analgesia and every hour thereafter until delivery of the placenta.
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.
17 secondary outcomes
Maternal blood glucose variability and dysglycemic events
Time frame: At baseline immediately before epidural analgesia and every hour thereafter until delivery of the placenta
Maternal plasma cortisol change
Time frame: Immediately before epidural analgesia and 2 hours after its initiation
Labor and delivery characteristics
Time frame: From initiation of epidural analgesia until delivery of the placenta.
Maternal intrapartum adverse events
Time frame: From initiation of epidural analgesia until delivery of the placenta.
Change in maternal body temperature
Time frame: At baseline immediately before epidural analgesia and every hour thereafter until birth.
Incidence of intrapartum fever
Time frame: From initiation of epidural analgesia until birth.
Umbilical arterial blood pH
Time frame: Immediately after birth.
Umbilical arterial partial pressure of carbon dioxide
Time frame: Immediately after birth.
Umbilical arterial partial pressure of oxygen
Time frame: Immediately after birth
Umbilical arterial base excess
Time frame: Immediately after birth
Umbilical arterial lactate concentration
Time frame: Immediately after birth
Apgar score
Time frame: At 1, 3 and 5 minutes after birth
Neonatal respiratory support
Time frame: From birth through 48 hours after birth
Neonatal intensive care unit admission
Time frame: From birth through 48 hours after birth
Neonatal jaundice
Time frame: From birth through 48 hours after birth.
Symptomatic neonatal hypoglycemia
Time frame: From birth through 48 hours after birth.
Neonatal heel-prick capillary blood glucose concentration
Time frame: Immediately after birth and at 1 hour after birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, run by Hanoi Medical University at 3 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thanh Hùng Trần, MD (+84367378519, thanhhungvt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of maternal capillary blood glucose concentration (time frame: At baseline immediately before epidural analgesia and every hour thereafter until delivery of the placenta.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.