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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section Complications; Gestational Diabetes
• Intervention / Treatment: Dietary supplement: Oral glucose in liquid form

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Antti Vaananen, MD PhD; Phone Number: 358504271850; Email: antti.vaananen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • HUS/Women's hospital dept of obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Diabetic parturients excluding type I diabetics who visit the Helsinki University Central Hospital/Women's hospital for the treatment of their diabetes during pregnancy and are planned for cesarean delivery.

Description

Inclusion Criteria:

• Volunteers to participate in the study
• Diabetes, either gestational or type II
• Planned for cesarean delivery

Exclusion Criteria:

• Type I diabetes

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gestational diabetes; 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.	Dietary supplement: Oral glucose in liquid form; A glucose containing drink that has a fixed dose of 25 g of glucose per can.; Other Names: Pre-op drink
Type II diabetes; 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.	Dietary supplement: Oral glucose in liquid form; A glucose containing drink that has a fixed dose of 25 g of glucose per can.; Other Names: Pre-op drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal subjective well being after oral glucose dose during the preoperative fasting period	subjective assessment by the parturient (categorial)	4 hours

Collaborators and Investigators

• Sponsor: Women's Hospital HUS

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: Tutkimussuunnitelma_250322_III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No