NCT03440502

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 11, 2018

Last Update Submit

February 20, 2018

Conditions

Spinal Anaesthesia

Keywords

spinal anaesthesiacesarean sectiondiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • the incidence of complete failure of spinal block.

    effect of DM during pregnancy on the spinal block criteria during C.S the incidence of complete failure of spinal block.

    two years

Secondary Outcomes (1)

  • determine the effect of DM on the other spinal block criteria

    two years

Study Arms (2)

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

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

Interventions

spinal anaesthesiaPROCEDURE

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

control group.study group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Levy JH, Islas JA, Ghia JN, Turnbull C. A retrospective study of the incidence and causes of failed spinal anesthetics in a university hospital. Anesth Analg. 1985 Jul;64(7):705-10.

    PMID: 4014732BACKGROUND

  • Steiner LA, Hauenstein L, Ruppen W, Hampl KF, Seeberger MD. Bupivacaine concentrations in lumbar cerebrospinal fluid in patients with failed spinal anaesthesia. Br J Anaesth. 2009 Jun;102(6):839-44. doi: 10.1093/bja/aep050. Epub 2009 Mar 26.

    PMID: 19329469BACKGROUND

  • Jovanovic L, Peterson CM. The clinical utility of glycosylated hemoglobin. Am J Med. 1981 Feb;70(2):331-8. doi: 10.1016/0002-9343(81)90770-1.

    PMID: 6781340BACKGROUND

  • Hillier TA, Vesco KK, Pedula KL, Beil TL, Whitlock EP, Pettitt DJ. Screening for gestational diabetes mellitus: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 May 20;148(10):766-75. doi: 10.7326/0003-4819-148-10-200805200-00009.

    PMID: 18490689BACKGROUND

  • Jovanovic L, Pettitt DJ. Gestational diabetes mellitus. JAMA. 2001 Nov 28;286(20):2516-8. doi: 10.1001/jama.286.20.2516. No abstract available.

    PMID: 11722247BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Alyaa Alaa Abd Manaf, resident

CONTACT

01069313668alyaa92alaa@yahoo.com

Fatma Ahmed Abd El _Aal, Professor

CONTACT

01113221317

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 11, 2018

First Posted

February 22, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share