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NCT05396378 Clinical Trial

Early Recovery After Cesarean Delivery - Maternal Glucose Homeostasis Following Preoperative Glucose Dose

Gestational Diabetes Clinical Trial

Official title:
Early Recovery After Cesarean Delivery - Maternal Glucose Homeostasis Following Preoperative Glucose Dose in Diabetic Parturients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05396378
Other study ID # Tutkimussuunnitelma_250322_III
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date December 31, 2023

Study information
Verified date April 2023
Source Women's Hospital HUS
Contact Marja Kaijomaa, MD PhD
Phone 358504279650
Email marja.kaijomaa@hus.fi
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diabetic parturients planned for cesarean delivery will be recruited for the study. They will receive a fixed glucose dose to mimize the effects of fasting preoperatively and their blood glucose levels will be monitored.

Description:

Informed voluntary parturients planned for cesarean delivery will be informed about the study. The parturients will get prepacked glucose drink containing 100 g and 50 g glucose, respectively. They will consume the 100 g of glucose the night before the planned operation and the 50 g on the morning of the planned cesarean delivery. Their blood glucose level will be monitored by percutaneous continuous blood glucose monitoring every 30 minutes for 2 hours following the glucose dose in the evening and for four hours in the morning of the operation. The subjective well being of these parturients will be also qualitatively assessed.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Volunteers to participate in the study - Diabetes, either gestational or type II - Planned for cesarean delivery Exclusion Criteria: - Type I diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral glucose in liquid form
A glucose containing drink that has a fixed dose of 25 g of glucose per can.

Locations
Country Name City State
Finland HUS/Women's hospital dept of obstetrics Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Women's Hospital HUS

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase of blood glucose following the oral glucose dose The effect of oral glucose dose on the parturient's blood glucose level (mM) 4 hours
Secondary Maternal subjective well being after oral glucose dose during the preoperative fasting period subjective assessment by the parturient (categorial) 4 hours
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