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

NCT05396378 | Unknown

• 1 other identifier: Tutkimussuunnitelma_250322_III
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maternal subjective well being after oral glucose dose during the preoperative fasting period

  4 hours

Study Arms (2)

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

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

Interventions

Oral glucose in liquid form DIETARY_SUPPLEMENT

A glucose containing drink that has a fixed dose of 25 g of glucose per can.

Also known as: Pre-op drink

Gestational diabetes; Type II diabetes

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Type I diabetes

Sponsors & Collaborators

• Women's Hospital HUS: lead

Study Sites (1)

HUS/Women's hospital dept of obstetrics

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Marja Kaijomaa, MD PhD

CONTACT

358504279650; marja.kaijomaa@hus.fi

Antti Vaananen, MD PhD

CONTACT

358504271850; antti.vaananen@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRincipal investigator

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: May 31, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)