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出境医 / 临床实验 / Neuroaxial Labour Analgesia

Neuroaxial Labour Analgesia

Study Description
Brief Summary:

The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

The secondary objective of this study is to compare the and fetomaternal outcomes


Condition or disease Intervention/treatment Phase
Labor Analgesia Procedure: Dural Puncture Epidural Technique Procedure: Combined Spinal Epidural without intrathecal opioids Procedure: epidural Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial assignment placed in sealed envelopes.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : June 1, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: combined spinal epidural group
Bupivacaine 2.5 mg
 Procedure: Combined Spinal Epidural without intrathecal opioids
three labor analgesia techniques
Active Comparator: dura puncture epidural group
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
 Procedure: Dural Puncture Epidural Technique
three labor analgesia techniques
Active Comparator: epidural
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
 Procedure: epidural
three labor analgesia techniques
Outcome Measures
Primary Outcome Measures :
  1. epidural Local anesthetic consumption [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Maternal hypotension [ Time Frame: 1 year ]
    maternal mean arterial blood pressure less than 50 mmhg

  2. incidence of fetal bradycardia [ Time Frame: 1 year ]
    a fetal heart rate of less than 100 beats per minute

  3. incidence of maternal pruritus [ Time Frame: 1 year ]
    Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe

  4. labour pain scores [ Time Frame: 1 year ]
    Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females requesting labor analgesia
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Nulliparous parturient
  2. Singleton, vertex gestation at term (37-42 weeks)
  3. Less than 5 cm dilation
  4. request an epidural technique for labor analgesia

Exclusion Criteria:

  1. Hypersensitivity to local the study drugs
  2. Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
  3. Any contraindication to the administration of an epidural technique
  4. Risk factor for cesarean delivery.
  5. fetal anomalies
Contacts and Locations

Locations
Layout table for location information
Egypt
Ain Shams University
Cairo, Abbasyia, Egypt, 002
Kuwait
Elite Hospital
Kuwait, Abbasyia, Kuwait, 002
Sponsors and Collaborators
Wahba bakhet
elite medical hospital
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019) 		epidural Local anesthetic consumption [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		labour pain scores [ Time Frame: 1 year ]
Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • Maternal hypotension [ Time Frame: 1 year ]
    maternal mean arterial blood pressure less than 50 mmhg
  • incidence of fetal bradycardia [ Time Frame: 1 year ]
    a fetal heart rate of less than 100 beats per minute
  • incidence of maternal pruritus [ Time Frame: 1 year ]
    Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe
  • labour pain scores [ Time Frame: 1 year ]
    Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Maternal hypotension [ Time Frame: 1 year ]
    maternal mean arterial blood pressure less than 50 mmhg
  • incidence of fetal bradycardia [ Time Frame: 1 year ]
    a fetal heart rate of less than 100 beats per minute
  • incidence of maternal pruritus [ Time Frame: 1 year ]
    Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroaxial Labour Analgesia
Official Title  ICMJE A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
Brief Summary

The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

The secondary objective of this study is to compare the and fetomaternal outcomes
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial assignment placed in sealed envelopes.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Labor Analgesia
Intervention  ICMJE
  • Procedure: Dural Puncture Epidural Technique
    three labor analgesia techniques
  • Procedure: Combined Spinal Epidural without intrathecal opioids
    three labor analgesia techniques
  • Procedure: epidural
    three labor analgesia techniques
Study Arms  ICMJE
  • Active Comparator: combined spinal epidural group
    Bupivacaine 2.5 mg
    Intervention: Procedure: Combined Spinal Epidural without intrathecal opioids
  • Active Comparator: dura puncture epidural group
    Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
    Intervention: Procedure: Dural Puncture Epidural Technique
  • Active Comparator: epidural
    Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
    Intervention: Procedure: epidural
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2019) 		120
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2019) 		160
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Nulliparous parturient
  2. Singleton, vertex gestation at term (37-42 weeks)
  3. Less than 5 cm dilation
  4. request an epidural technique for labor analgesia

Exclusion Criteria:

  1. Hypersensitivity to local the study drugs
  2. Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
  3. Any contraindication to the administration of an epidural technique
  4. Risk factor for cesarean delivery.
  5. fetal anomalies
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: females requesting labor analgesia
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt,   Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980951
Other Study ID Numbers  ICMJE 2019 WB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wahba bakhet, Ain Shams University
Study Sponsor  ICMJE Wahba bakhet
Collaborators  ICMJE elite medical hospital
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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