Effect of Diabetes Mellitus on Spinal Block Criteria During Cesarean Section

February 20, 2018 updated by: Alyaa Alaa Aldin Abd Manaf, Assiut University

The current study aimed at studying the effect of DM during pregnancy on the spinal block criteria during C.S.

The primary end point of the trial is the incidence of complete failure of spinal block.

Secondary endpoint is to determine the effect of DM on the other spinal block criteria as onset and duration of block, level of spinal block, rate of regression, hemodynamic changes, doses of inotropes and incidence of complications

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Regional anaesthetic techniques are now the most frequently used type of anaesthetic used for caesarean deliveries. They have a better safety profile than general anaesthesia in the pregnant woman. The choice of whether to use a spinal, epidural or combined spinal-epidural technique will depend on patient and surgical factors.

Although spinal (subarachnoid or intrathecal) anaesthesia is generally regarded as one of the most reliable types of regional block methods, the possibility of failure has long been recognized.

Most experienced practitioners would consider the incidence of failure with spinal anaesthesia to be extremely low, perhaps less than 1%. However, a figure as high as 17% has been quoted from an American teaching hospital, yet most of the failures were judged to be 'avoidable Spinal anaesthesia (SA) is a frequently used anaesthetic technique, and success rates and patient satisfaction are generally high. However, there are numerous reports of failed SA (FSA), and published failure rates in large series of SA range from 0.46% to 17%. The reasons most commonly provided to explain failure are technical problems, errors of judgement with respect to pharmacological factors, such as inadequate dose of local anaesthetic (LA), and inadequate positioning of the patient. . Proposed mechanisms for inadequate block despite correct dosing and injection technique are maldistribution , variability in the anatomy of the lumbar subarachnoid space, inadvertent subdural or epidural injection, and resistance to the effects of LA.

Successful spinal anaesthesia requires the deposition of the correct dose of the correct drug in the CSF that is in free continuity with the spinal cord and cauda equina, and that there are no barriers, either physiological, biochemical or mechanical, to prevent the normal anticipated action of the drug in the spinal cord. Gestational diabetes mellitus (GDM) refers to any degree of glucose intolerance with onset or first recognition during pregnancy. It occurs in 2-9% of all pregnancies and accounts for 90% of cases of diabetes mellitus complicating pregnancy. A1C is routinely measured approximately every 3 months in individuals with diabetes to assess the mean glucose concentration. The erythrocyte life span is ∼120 days. Thus, the 3-month interval between tests of A1C reflects the mean blood glucose over the preceding weeks to months. Hence, the rate of change of A1C in pregnancy reflects the glycemic control over the past few weeks Hoppe et al. declared diabetes mellitus (DM)as a possible cause of SA failure in a case series consisting four obstetric patients.

two possible factors may be important for quality and level of SA inpatients with DM. First is neuropathy and second is possible changes in composition of CSF such as density or volume secondary to hyperglicemia in blood and CSF .So the investigators hypothesized that DM could affect the success of SA

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Fatma Ahmed Abd El _Aal, Professor
  • Phone Number: 01113221317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Parturients aged 18 or older (American Society of Anesthesiologist physical status II-III parturients ASA II-III) undergoing cesarean delivery under spinal anaesthesia, singleton pregnancy, full term, elective.

Description

Inclusion Criteria:

Inclusion criteria for control group.

  • Parturients aged 18 or older (American Society of Anesthesiologist physical status II-III parturients ASA II-III) undergoing cesarean delivery under spinal anaesthesia, singleton pregnancy, full term, elective.

Inclusion criteria for study group.

  • The same as control group but with DM or gestational diabetes.

Exclusion Criteria:

  • Parturients taller than 180 cm or shorter than 150 cm.
  • Body mass index > 45 kg/m2.
  • Known anatomical anomaly such as scolyosis or kyphosis.
  • Refusal of spinal anesthesia.
  • Contraindications to spinal anaesthesia (allergy to local anaesthetic or a bleeding diathesis or infection at the site of injection).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control group.
Parturients aged 18 or older (American Society of Anesthesiologist physical status II-III parturients ASA II-III) undergoing cesarean delivery under spinal anaesthesia, singleton pregnancy, full term, elective
Procedure: spinal anaesthesia
Intrathecal block under strict aseptic conditions will be performed by median approach (L3-4 or L4-5) under sitting position by anesthesiologists . 25 Gauge sprotte spinal needles and 2-3 mLof 0.5% hyperbaric bupivacaine
study group
The same as control group but with DM or gestational diabetes Parturients aged 18 or older (American Society of Anesthesiologist physical status II-III parturients ASA II-III) undergoing cesarean delivery under spinal anaesthesia, singleton pregnancy, full term, elective
Procedure: spinal anaesthesia
Intrathecal block under strict aseptic conditions will be performed by median approach (L3-4 or L4-5) under sitting position by anesthesiologists . 25 Gauge sprotte spinal needles and 2-3 mLof 0.5% hyperbaric bupivacaine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the incidence of complete failure of spinal block.
Time Frame: two years
effect of DM during pregnancy on the spinal block criteria during C.S the incidence of complete failure of spinal block.
two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
determine the effect of DM on the other spinal block criteria
Time Frame: two years
the other spinal block criteria as duration of block
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Diabetes and spinal block

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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