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

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: Peripheral blood glucose levels were monitored

• Registration Number: NCT04915716
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Last Update Submitted: 2021-06-04
• Study First Posted: 2021-06-07
• Last Update Posted: 2021-06-07
• Study Start: 2021-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant women with GDM	Peripheral blood glucose levels were monitored	pregnant women with gestational diabetes mellitus
healthy pregnant woman	Peripheral blood glucose levels were monitored	healthy pregnant woman

Primary Outcome Measures

Name	Time	Method
blood glucose concentration	37 weeks to 40 weeks gestation	Peripheral blood glucose concentration of maternal fingers

Secondary Outcome Measures

Name	Time	Method
blood glucose concentration	37 weeks to 40 weeks gestation	Blood glucose concentration in the peripheral finger of the newborn