NCT04405336

Brief Summary

cesarean section rate become increasing nowadays

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 28, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

10 months

First QC Date

May 23, 2020

Last Update Submit

May 21, 2021

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • The number of women who will feel less pain post CS

    the degree of pain that will be felt post CS

    2 days

Study Arms (3)

giving tab block

ACTIVE COMPARATOR

giving patients tab block

Drug: tab blockDrug: women who will not receive tab block or PCA

giving PCA

ACTIVE COMPARATOR

Giving PCA to patients

Drug: PCADrug: women who will not receive tab block or PCA

Patients who will not receive PCA or tab block

NO INTERVENTION

No tab block or PCA

Interventions

tab blockDRUG

injection of tab block to women who are doing cs

giving tab block
PCADRUG

giving women PCA

giving PCA
women who will not receive tab block or PCADRUG

no tab block or PCA will be given

giving PCAgiving tab block

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing CS
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women coming for an elective CS

You may not qualify if:

  • women who has a n emergency CS or complicated normal deivery needs urgent CS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeera( Al Gazeera) hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dental OcclusionPassive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaSkin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2020

First Posted

May 28, 2020

Study Start

May 28, 2020

Primary Completion

March 15, 2021

Study Completion

April 1, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

EG(1)