NCT03980951

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

June 5, 2019

Last Update Submit

March 20, 2020

Conditions

Labor Analgesia

Outcome Measures

Primary Outcomes (1)

  • epidural Local anesthetic consumption

    1 year

Secondary Outcomes (4)

  • Maternal hypotension

    1 year

  • incidence of fetal bradycardia

    1 year

  • incidence of maternal pruritus

    1 year

  • labour pain scores

    1 year

Study Arms (3)

combined spinal epidural group

ACTIVE COMPARATOR

Bupivacaine 2.5 mg

Procedure: Combined Spinal Epidural without intrathecal opioids

dura puncture epidural group

ACTIVE COMPARATOR

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min

Procedure: Dural Puncture Epidural Technique

epidural

ACTIVE COMPARATOR

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min

Procedure: epidural

Interventions

Dural Puncture Epidural TechniquePROCEDURE

three labor analgesia techniques

dura puncture epidural group
Combined Spinal Epidural without intrathecal opioidsPROCEDURE

three labor analgesia techniques

combined spinal epidural group
epiduralPROCEDURE

three labor analgesia techniques

epidural

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales requesting labor analgesia
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain Shams University

Cairo, Abbasyia, 002, Egypt

Location

Elite Hospital

Kuwait City, Abbasyia, 002, Kuwait

Location

Related Publications (1)

  • Bakhet WZ. A randomized comparison of epidural, dural puncture epidural, and combined spinal-epidural without intrathecal opioids for labor analgesia. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):231-236. doi: 10.4103/joacp.JOACP_347_19. Epub 2021 Jul 15.

    PMID: 34349372DERIVED

MeSH Terms

Interventions

Injections, Epidural

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial assignment placed in sealed envelopes.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 10, 2019

Study Start

December 1, 2017

Primary Completion

May 1, 2018

Study Completion

June 1, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)KU(1)