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Neuroaxial Labour Analgesia

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ClinicalTrials.gov Identifier: NCT03980951
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
elite medical hospital
Information provided by (Responsible Party):
Wahba bakhet, Ain Shams University

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

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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

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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

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): NCT03980951


Locations
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Egypt
Ain Shams University
Cairo, Abbasyia, Egypt, 002
Kuwait
Elite Hospital
Kuwait, Abbasyia, Kuwait, 002
Sponsors and Collaborators
Wahba bakhet
elite medical hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wahba bakhet, Director, Ain Shams University
ClinicalTrials.gov Identifier: NCT03980951    
Other Study ID Numbers: 2019 WB
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents