NCT04810767

Brief Summary

This retrospective study will include Women who will attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective CD under spinal anesthesia with horizontal lower abdominal surgical incision within last two years. Exclusion criteria will be refusal to participate, age less than 18 years, recent CD (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder. Data collection Participants will be contacted personally by one of study authors. Data collected are consisted of:

  • Participants' characteristics as Age, parity and ways of delivery, weight, height, residency, husband smoking status, work, previous abdominal surgery, history of diabetes mellitus and hypertension.
  • Last CD related data which include presence of multiple pregnancies, if CD was in private/public facility, presence surgical wound infection.
  • Pain experienced will be assessed by questionnaire described by Nikolajsen et al, 2004

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

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

March 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

March 21, 2021

Last Update Submit

September 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chronic pain

    Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004

    Three months after the last ceserean section

Interventions

Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

20-40 years old Women attending to Al Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years

You may qualify if:

  • Women attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years

You may not qualify if:

  • refusal to participate, age less than 18 years, recent ceserean section (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kareem ElGebaly, Lecturer

    Lecturer of anesthesia and ICU

    STUDY CHAIR
  • Hossam Eldin Mostafa, Consultant

    Consultant of anesthesia and ICU Elhelal insurance hospital

    STUDY DIRECTOR

Central Study Contacts

Bahaa M Refaie, Lecturer

CONTACT

Mohammed A Soliman

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 23, 2021

Study Start

May 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

September 21, 2021

Record last verified: 2021-09