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Clinical Trials/NCT03980951
NCT03980951CompletedNot Applicable

A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.

Wahba bakhet4 sites in 2 countries120 target enrollmentStarted: December 1, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
4
Primary Endpoint
epidural Local anesthetic consumption
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Hypersensitivity to local the study drugs
  • •Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
  • •Any contraindication to the administration of an epidural technique
  • •Risk factor for cesarean delivery.
  • •fetal anomalies

Outcomes

Primary Outcomes

epidural Local anesthetic consumption

Time Frame: 1 year

Secondary Outcomes

  • incidence of fetal bradycardia(1 year)
  • Maternal hypotension(1 year)
  • incidence of maternal pruritus(1 year)
  • labour pain scores(1 year)

Investigators

Sponsor
Wahba bakhet
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Wahba bakhet

Director

Ain Shams University

Study Sites (4)

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