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

Not yet recruiting

• Conditions: Cesarean Section Complications; Gestational Diabetes
• Interventions: Dietary Supplement: Oral glucose in liquid form

• Registration Number: NCT05396378
• Lead Sponsor: Women's Hospital HUS

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-05-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25
• Study Start: 2023-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gestational diabetes	Oral glucose in liquid form	Any parturient who after information agrees to participate in the study. The treatment of the gestational diabetes may be by diet, metformin or insulin according to the hospital's normal protocol.
Type II diabetes	Oral glucose in liquid form	Any parturient who after information agrees to participate in the study. The treatment of the diabetes may be by diet, metformin or insulin according to the hospital's normal protocol.

Primary Outcome Measures

Name	Time	Method
Increase of blood glucose following the oral glucose dose	4 hours	The effect of oral glucose dose on the parturient's blood glucose level (mM)

Secondary Outcome Measures

Name	Time	Method
Maternal subjective well being after oral glucose dose during the preoperative fasting period	4 hours	subjective assessment by the parturient (categorial)

Trial Locations

Locations (1)

HUS/Women's hospital dept of obstetrics; 🇫🇮 Helsinki, Finland