Chronic PainNCT04810767
Chronic Pain After CS in Egypt
An observational study of Chronic Pain, run by Bahaa Mohammed Refaie.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Questionnaire
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Mohammed A Soliman contact
About this study
Official title: Prevalence and Risk Factors for Chronic Pain After Cesarean Delivery in Upper Egypt: Retrospective Study
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.
Read more
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
- Conditions
- Chronic Pain
- Being tested
- Questionnaire
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004
Measured: Three months after the last ceserean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study startMay 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahaa Mohammed Refaie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahaa Mohammed Refaie, Sohag University
- Investigators
- Kareem ElGebaly, Lecturer, Study chair, Lecturer of anesthesia and ICUHossam Eldin Mostafa, Consultant, Study director, Consultant of anesthesia and ICU Elhelal insurance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810767
- Sponsor's protocol ID
- 2020
- Status last verified
- Sep 2021
- First submitted
- 21 Mar 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors for Chronic Pain After Cesarean Delivery in Upper Egypt: Retrospective Study
- ClinicalTrials.gov ID
- NCT04810767
- Acronym / sponsor ID
- 2020
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bahaa Mohammed RefaieUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePain experienced assessed by questionnaire described by Nikolajsen et al, 2004 | Other | – |
Primary outcome
Chronic pain
Time frame: Three months after the last ceserean section
Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A Soliman contact
Kareem ElGebaly, Lecturer study chair
Lecturer of anesthesia and ICU
Hossam Eldin Mostafa, Consultant study director
Consultant of anesthesia and ICU Elhelal insurance hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Bahaa Mohammed Refaie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahaa M Refaie, Lecturer (00201026887257, bahaarefaay@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain (time frame: Three months after the last ceserean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.