NCT04617249

Brief Summary

The number of cesarean sections worldwide has markedly been increasing since 1985.Intrathecal anesthesia is preferred by most anesthesiologists over general anesthesia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 31, 2020

Last Update Submit

October 31, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • the number of women who will have less pain

    the number of women who will have less pain post procedure

    3 days

Study Arms (2)

Giving median anesthesia

ACTIVE COMPARATOR
Procedure: median anesthesia

Giving paramedian anesthesia

ACTIVE COMPARATOR
Procedure: paramedian anesthesia

Interventions

median anesthesiaPROCEDURE

giving median anesthesia

Giving median anesthesia
paramedian anesthesiaPROCEDURE

giving paramedian anesthesia

Giving paramedian anesthesia

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women undergoing CS
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-42 years
  • Scheduled for elective cesarean section
  • ASA II

You may not qualify if:

  • Age \<18 years or \>42 years
  • ASA \>II
  • Emergency cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeera( Al Gazeera) hospital

Giza, Egypt

Location

Study Officials

  • Mahmoud Alalfy

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: anesthesia with median route versus paramedian route
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2020

First Posted

November 5, 2020

Study Start

November 5, 2020

Primary Completion

April 25, 2021

Study Completion

May 15, 2021

Last Updated

November 5, 2020

Record last verified: 2020-10

Locations

EG(1)