Indication of Cesarean SectionNCT03358615
Robson Classification of Indications of Cesarean Section at MUH
An observational study of Indication of Cesarean Section, run by Mansoura University at 1 site in Egypt.
Trial summary
Robson classification of Cesarean section rates and indications allows evaluation and comparison of the contributors to the Cesarean section rate and their impact. It also allows comparison between institutions, regions, and countries that adopt this classification Robson's system classifies all deliveries into one of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Indication of Cesarean Section
- What is being tested?
- cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2016to 31 Dec 2016
- How long will I take part?
- 1 Year
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective study of an obstetric ,for booked (inpatient), non-booked (emergency) cases. Full data sheet- from for the case (history, examination, diagnosis, pregnancy duration ,labor onset: spontaneous or induced , and previous pregnancy C.S or not
Who may be able to join
- all cases who underwent CS at Mansoura University Hospital inpatients and emergency cases
Who cannot join
- non
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robson Classification of Indications of Cesarean Section at a University Hospital in Egypt
Robson classification of Cesarean section rates and indications allows evaluation and comparison of the contributors to the Cesarean section rate and their impact. It also allows comparison between institutions, regions, and countries that adopt this classification Robson's system classifies all deliveries into one of ten groups on the basis of five parameters: obstetric history (parity and previous cesarean section), onset of labor (spontaneous, induced, or cesarean section before onset of labor), fetal presentation or lie (cephalic, breech, or transverse), number of neonates, and gestational age (preterm or term; panel This study evaluates C.S rates and indications according to Robson classification in a University Hospital in a year (2016) to compare with international standards
- Conditions
- Indication of Cesarean Section
- Being tested
- cesarean section
- Keywords
- robson classification, Egypt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean sectionProcedure or surgery
assessment of the indications of cesarean section according to Robson criteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of C.S rates and indications according to Robson classification
comparison of the results with the international standards
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication of Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Nabil, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358615
- Sponsor's protocol ID
- Robsen classification
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robson Classification of Indications of Cesarean Section at a University Hospital in Egypt
- ClinicalTrials.gov ID
- NCT03358615
- Acronym / sponsor ID
- Robsen classification
- Conditions
- Indication of Cesarean Section
- Keywords
- robson classification, Egypt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 30 Nov 2017 (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.
Robson classification of Cesarean section rates and indications allows evaluation and comparison of the contributors to the Cesarean section rate and their impact. It also allows comparison between institutions, regions, and countries that adopt this classification Robson's system classifies all deliveries into one of ten groups on the basis of five parameters: obstetric history (parity and previous cesarean section), onset of labor (spontaneous, induced, or cesarean section before onset of labor), fetal presentation or lie (cephalic, breech, or transverse), number of neonates, and gestational age (preterm or term; panel This study evaluates C.S rates and indications according to Robson classification in a University Hospital in a year (2016) to compare with international standards
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective study of an obstetric ,for booked (inpatient), non-booked (emergency) cases. Full data sheet- from for the case (history, examination, diagnosis, pregnancy duration ,labor onset: spontaneous or induced , and previous pregnancy C.S or not
Key inclusion criteria (1 listed)
- all cases who underwent CS at Mansoura University Hospital inpatients and emergency cases
Key exclusion criteria (1 listed)
- non
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 |
|---|---|---|
| cesarean sectionassessment of the indications of cesarean section according to Robson criteria | Procedure or surgery | – |
Primary outcome
Evaluation of C.S rates and indications according to Robson classification
Time frame: one year
comparison of the results with the international standards
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indication of Cesarean Section, run by Mansoura University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of C.S rates and indications according to Robson classification (time frame: one year). 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 30 Nov 2017.