Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

Official title:

Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04915716
• Other study ID #: SAHoWMU-CR2021-07-202
• Status: Not yet recruiting
• 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
• 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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

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