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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04915716
Other study ID # SAHoWMU-CR2021-07-202
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 30, 2023

Study information

Verified date June 2021
Source Second Affiliated Hospital of Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date September 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: (1) 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. Exclusion Criteria: (1) 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;

Study Design


Intervention

Other:
Peripheral blood glucose levels were monitored
Peripheral blood glucose levels were monitored

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary blood glucose concentration Peripheral blood glucose concentration of maternal fingers 37 weeks to 40 weeks gestation
Secondary blood glucose concentration Blood glucose concentration in the peripheral finger of the newborn 37 weeks to 40 weeks gestation
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