Gestational Diabetes MellitusNCT04915716
Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
Objective: To observe the effect of different fasting time on neonatal blood glucose in pregnant women with gestational diabetes mellitus (GDM). Methods: 122 pregnant women with gestational diabetes mellitus were selected from September 2018 to September 2020 in XX Hospital for regular prenatal examination, matching… 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
- What is being tested?
- Peripheral blood glucose levels were monitored
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: pregnant women
Who may be able to join
- The pregnant woman is born at term and has a single child; (2) Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as gestational diabetes mellitus; (3) Pregnant women with body mass index (BMI) < 35kg/㎡; (4) All the operations were performed electively, and epidural anesthesia was used as the surgical anesthesia.
Who cannot join
- Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension; (2) Insufficiency of vital organ function or complicated tumor; (3) Pregnant women with other pregnancy complications besides GDM, such as preeclampsia, etc.; (4) The operation method is classical cesarean section or pregnant women with postpartum hemorrhage;
About this study
Objective: To observe the effect of different fasting time on neonatal blood glucose in pregnant women with gestational diabetes mellitus (GDM). Methods: 122 pregnant women with gestational diabetes mellitus were selected from September 2018 to September 2020 in XX Hospital for regular prenatal examination, matching of pregnancy and delivery times, and undergoing elective lower uterine cesarean section to terminate pregnancy. The pregnant women were divided into 5 groups according to their fasting time before operation and whether they were given rehydration on the same day before operation, There were 27 cases in group B (fasting time 12.75 ± 0.48 hours, no rehydration before operation), 20 cases in group C (fasting time 15.65 ± 0.52 hours, no rehydration before operation), 24 cases in group D (fasting time 12.75 ± 0.48 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation), 24 cases in Group E (fasting time 15.65 ± 0.52 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation). The blood glucose of pregnant women within half an hour before operation, the blood glucose of newborns after delivery and the incidence of neonatal hypoglycemia were observed and recorded.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Peripheral blood glucose levels were monitored
- Keywords
- gestational diabetes mellitus, cesarean section, preoperative fasting, neonatal blood glucose
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood glucose levels were monitoredOther
Peripheral blood glucose levels were monitored
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnant woman | healthy pregnant woman Receives: Other: Peripheral blood glucose levels were monitored | |
| pregnant women with GDM | pregnant women with gestational diabetes mellitus Receives: Other: Peripheral blood glucose levels were monitored |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose concentration
Peripheral blood glucose concentration of maternal fingers
Measured: 37 weeks to 40 weeks gestation
Secondary outcomes (1)
blood glucose concentration
Blood glucose concentration in the peripheral finger of the newborn
Measured: 37 weeks to 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915716
- Sponsor's protocol ID
- SAHoWMU-CR2021-07-202
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04915716
- Acronym / sponsor ID
- SAHoWMU-CR2021-07-202
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- gestational diabetes mellitus, cesarean section, preoperative fasting, neonatal blood glucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 7 Jun 2021 (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.
Objective: To observe the effect of different fasting time on neonatal blood glucose in pregnant women with gestational diabetes mellitus (GDM). Methods: 122 pregnant women with gestational diabetes mellitus were selected from September 2018 to September 2020 in XX Hospital for regular prenatal examination, matching of pregnancy and delivery times, and undergoing elective lower uterine cesarean section to terminate pregnancy. The pregnant women were divided into 5 groups according to their fasting time before operation and whether they were given rehydration on the same day before operation, There were 27 cases in group B (fasting time 12.75 ± 0.48 hours, no rehydration before operation), 20 cases in group C (fasting time 15.65 ± 0.52 hours, no rehydration before operation), 24 cases in group D (fasting time 12.75 ± 0.48 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation), 24 cases in Group E (fasting time 15.65 ± 0.52 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation). The blood glucose of pregnant women within half an hour before operation, the blood glucose of newborns after delivery and the incidence of neonatal hypoglycemia were observed and recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant woman | – | Other: Peripheral blood glucose levels were monitoredhealthy pregnant woman |
| pregnant women with GDM | – | Other: Peripheral blood glucose levels were monitoredpregnant women with gestational diabetes mellitus |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women
Key inclusion criteria (1 listed)
- The pregnant woman is born at term and has a single child; (2) Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as gestational diabetes mellitus; (3) Pregnant women with body mass index (BMI) < 35kg/㎡; (4) All the operations were performed electively, and epidural anesthesia was used as the surgical anesthesia.
Key exclusion criteria (1 listed)
- Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension; (2) Insufficiency of vital organ function or complicated tumor; (3) Pregnant women with other pregnancy complications besides GDM, such as preeclampsia, etc.; (4) The operation method is classical cesarean section or pregnant women with postpartum hemorrhage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood glucose levels were monitoredPeripheral blood glucose levels were monitored | Other | healthy pregnant woman, pregnant women with GDM |
Primary outcome
blood glucose concentration
Time frame: 37 weeks to 40 weeks gestation
Peripheral blood glucose concentration of maternal fingers
1 secondary outcome
blood glucose concentration
Time frame: 37 weeks to 40 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus, run by Second Affiliated Hospital of Wenzhou Medical University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose concentration (time frame: 37 weeks to 40 weeks gestation). 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 7 Jun 2021.