Gestational DiabetesNCT05396378
Early Recovery After Cesarean Delivery - Maternal Glucose Homeostasis Following Preoperative Glucose Dose
An observational study of Gestational Diabetes and Cesarean Section Complications, run by Women's Hospital HUS at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Gestational Diabetes, Cesarean Section Complications
- What is being tested?
- Oral glucose in liquid form
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jul 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Adult
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.
Who may be able to join
- Volunteers to participate in the study
- Diabetes, either gestational or type II
- Planned for cesarean delivery
Who cannot join
- Type I diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Oral glucose in liquid form
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose in liquid formDietary supplement
Also called Pre-op drink
A glucose containing drink that has a fixed dose of 25 g of glucose per can.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Oral glucose in liquid form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of blood glucose following the oral glucose dose
The effect of oral glucose dose on the parturient's blood glucose level (mM)
Measured: 4 hours
Secondary outcomes (1)
Maternal subjective well being after oral glucose dose during the preoperative fasting period
subjective assessment by the parturient (categorial)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital HUS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antti Vaananen, Women's Hospital HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396378
- Sponsor's protocol ID
- Tutkimussuunnitelma_250322_III
- Status last verified
- Apr 2023
- First submitted
- 27 May 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recovery After Cesarean Delivery - Maternal Glucose Homeostasis Following Preoperative Glucose Dose in Diabetic Parturients
- ClinicalTrials.gov ID
- NCT05396378
- Acronym / sponsor ID
- Tutkimussuunnitelma_250322_III
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Women's Hospital HUSUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes | – | Dietary Supplement: Oral glucose in liquid formAny 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 | – | Dietary Supplement: Oral glucose in liquid formAny 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Volunteers to participate in the study
- Diabetes, either gestational or type II
- Planned for cesarean delivery
Key exclusion criteria (1 listed)
- Type I diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose in liquid formAlso: Pre-op drinkA glucose containing drink that has a fixed dose of 25 g of glucose per can. | Dietary supplement | Gestational diabetes, Type II diabetes |
Primary outcome
Increase of blood glucose following the oral glucose dose
Time frame: 4 hours
The effect of oral glucose dose on the parturient's blood glucose level (mM)
1 secondary outcome
Maternal subjective well being after oral glucose dose during the preoperative fasting period
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Cesarean Section Complications, run by Women's Hospital HUS at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marja Kaijomaa, MD PhD (358504279650, marja.kaijomaa@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of blood glucose following the oral glucose dose (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.