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Supine Versus Left Lateral Tilted Position During Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03182114
Recruitment Status : Unknown
Verified July 2018 by Ahmed Hasanin, Cairo University.
Recruitment status was:  Recruiting
First Posted : June 9, 2017
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Study Description
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Brief Summary:
In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Other: supine position Other: left lateral tilted position Drug: Bupivacaine Phase 4

Detailed Description:
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hemodynamic Effects of Supine Position Versus Left Lateral Tilted Position During Cesarean Delivery: a Randomized Controlled Trial.
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: supine position
the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position
 Other: supine position
the patient will be placed in regular supine position after spinal anesthesia

Drug: Bupivacaine
The patient will receive 10 mg Bupivacaine for spinal anesthesia
Other Name: Marcaine
Experimental: Left lateral tilted position
the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position
 Other: left lateral tilted position
the patient will be placed in left lateral tilted position after spinal anesthesia

Drug: Bupivacaine
The patient will receive 10 mg Bupivacaine for spinal anesthesia
Other Name: Marcaine


Outcome Measures
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Primary Outcome Measures :
  1. postspinal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group


Secondary Outcome Measures :
  1. severe postspinal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

  2. Post-delivery hypotension [ Time Frame: 10 minutes after delivery ]
    number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion

  3. systolic blood pressure [ Time Frame: 60 minutes after spinal block ]
    systolic blood pressure measured in mmHg

  4. diastolic blood pressure [ Time Frame: 60 minutes after spinal block ]
    diastolic blood pressure measured in mmHg

  5. heart rate [ Time Frame: 60 minutes after spinal block ]
    heart rate measured in beats per minute

  6. incidence of nausea and vomiting [ Time Frame: 60 minutes after spinal block ]
    number of patients who develop nausea and vomiting divided by the total number of patients in the group

  7. ephedrine consumption [ Time Frame: 60 minutes after spinal block ]
    total amount of ephedrine consumed during the operation (measured in milligrams)

  8. Atropine consumption [ Time Frame: 60 minutes after spinal block ]
    total amount of atropine consumed during the operation (measured in milligrams

  9. APGAR score [ Time Frame: 1 minute after delivery ]
    APGAR score for detection of the well being of the fetus

  10. APGAR score [ Time Frame: 10 minute after delivery ]
    APGAR score for detection of the well being of the fetus


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • full term
  • singleton pregnant women
  • scheduled for elective cesarean delivery

Exclusion Criteria:

  • Cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • baseline systolic blood pressure (SBP) < 100 mmHg
  • body mass index > 35
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182114


Contacts
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Contact: Ahmed Shash, Professor +201001033999 shashahmed@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: ahmed Hasanin, Lecturer    +2010095076954    ahmedmohamedhasanin@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Ahmed Mukhtar, Professor Head of research committee section in anesthesia department
More Information
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Responsible Party: Ahmed Hasanin, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03182114    
Other Study ID Numbers: N-52-2017
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents