NCT03111446

Brief Summary

Anesthesia for caesarian section in patients with HELLP syndrome is a challenge. Measures should be taken during caesarian delivery to guard against the maternal and fetal complications associated with HELLP syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 18, 2018

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

March 27, 2017

Last Update Submit

May 17, 2018

Conditions

HELLP Syndrome

Outcome Measures

Primary Outcomes (1)

  • The incidence of perioperative mortality in both groups.

    Maternal

    up to one week postoperative

Secondary Outcomes (5)

  • occurence bradycardia

    up to 24 hours postoperative

  • occurrence of tachycardia

    up to 24 hours postoperative

  • occurrence of hypotension

    up to 24 hours postoperative

  • occurrence of hypertension

    up to 24 hours postoperative

  • incidence of cerebral hemorrhage

    up to one week postoperative

Study Arms (2)

Spinal Anesthesia

ACTIVE COMPARATOR

Spinal anesthesia will be used to anesthetize patients in this group for caesarian section

Procedure: Spinal Anesthesia

General Anesthesia

ACTIVE COMPARATOR

Standardized General Anesthesia will be used to anesthetize patients in this group for caesarian section

Procedure: General Anesthesia

Interventions

Spinal AnesthesiaPROCEDURE

Spinal needle 25G with Quincke's bevel will be used. It will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 20 mcg fentanyl (total volume 2.4 ml) at the L3-4 interspace. The parturient will be returned to the supine position with a left lateral tilt of 15° to facilitate left uterine displacement. The upper sensory block level will be checked 5 min after the spinal injection by assessing the loss of cold sensation from alcohol swabs, to ensure that a Th6 sensory block level has been achieved.

Spinal Anesthesia
General AnesthesiaPROCEDURE

Pre-oxygenation with oxygen 100% via a tight fitting mask rapid sequence technique. Induction is by thiopental (5 mg kg lean body weight) and succinylcholine1.5 mg kg body weight), cricoid pressure should be applied before consciousness is lost and kept in place until confirmation of tracheal intubation with capnography and the cuff of the tracheal tube is inflated. Auscultating the chest helps exclude endobronchial intubation. At this point, surgery may commence.

General Anesthesia

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParturients with HELLP syndrome presented for elective caesarian section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with class (II) (12) HELLP syndrome scheduled for elective caesarian section:
  • Diagnosis of HELLP syndrome was based on the clinical diagnosis of preeclampsia and the following laboratory abnormalities (13):
  • Hemolysis: characteristic peripheral blood smear, serum lactic dehydrogenase (LDH) ≥ 600 U/ l, total bilirubin ≥ 1.2 mg /dl, decreased hemoglobin and hematocrit.
  • Elevated liver enzymes, defined as aspartate aminotransferase (AST). ≥ 70 U/ l, alanin aminotransferase (ALT) ≥ 50 U/ l and lactate dehydrogenase (LDH) ≥ 600 U/ l.
  • Low platelet count: class 2 HELLP having a platelet nadir between \> 50000 and 100000 mm-3.

You may not qualify if:

  • Emergency cases
  • Placenta praevia
  • Cardiovascular or cerebrovascular disease.
  • Morbid obesity with a BMI ≥40
  • Gestational age \<36 or \>41 weeks
  • Platelet counts less than 50000 mm-3; class 1 HELLP and class 3 HELLP having platelet count more than 100 000 mm-3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital, Faculty of medicine

Asyut, 71516, Egypt

Location

MeSH Terms

Conditions

HELLP Syndrome

Interventions

Anesthesia, SpinalAnesthesia, General

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 12, 2017

Study Start

April 15, 2017

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

May 18, 2018

Record last verified: 2017-04

Locations

EG(1)