Cesarean SectionNCT07194876
Robson Ten-Group Classification Study of Cesarean Section Rates in Assiut Hospitals
An observational study of Cesarean Section and Maternal Health, run by Assiut University.
Trial summary
Cesarean section (C-section) rates have increased worldwide, and Egypt is among the countries with the highest rates. In some hospitals, more than half of all births are done by cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Maternal Health
- How many people
- 770 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women delivering by cesarean section at Assiut University Hospital and Assiut General Hospital in Assiut, Egypt, between January and December 2026. Data will be collected from medical records and classified using the Robson Ten Group Classification System.
Who may be able to join
- Women who delivered by cesarean section at Assiut University Hospital or Assiut General Hospital during the study period (January-December 2026).
- Gestational age ≥ 28 weeks.
- Complete medical records available.
Who cannot join
- Vaginal deliveries.
- Cesarean deliveries before 28 weeks of gestation.
- Incomplete or missing medical records.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Survey Study Using the Ten-Group Robson Classification System to Evaluate Cesarean Section Rates and Maternal-Neonatal Outcomes in Assiut University Hospital and Assiut General Hospital
Cesarean section (C-section) rates have increased worldwide, and Egypt is among the countries with the highest rates. In some hospitals, more than half of all births are done by cesarean delivery. The World Health Organization (WHO) recommends using the "Robson Ten Group Classification System" to better understand and compare C-section rates.
This study will use the Robson classification system to evaluate the rate of cesarean deliveries in two hospitals in Assiut, Egypt: Assiut University Hospital and Assiut General Hospital. The study will collect information from medical records of women who delivered by cesarean section between January and December 2026.
The main goal is to identify which groups of women contribute most to the high C-section rate and to compare practices between the two hospitals. The study will also look at outcomes for both mothers and newborns. By doing this, we hope to provide useful information that can help improve obstetric care, reduce unnecessary cesarean deliveries, and improve health outcomes for mothers and babies in Egypt.
Read the detailed description
Cesarean section (C-section) rates have risen dramatically worldwide, with Egypt showing one of the fastest increases, from 4.6% in 1992 to nearly 52% in 2014. Current national data indicate a rate of 51.8%, placing Egypt among the top three countries globally in C-section prevalence. This upward trend highlights an urgent need for systematic evaluation and targeted interventions.
In 2015, the World Health Organization (WHO) endorsed the Robson Ten Group Classification System (TGCS) as the international standard for assessing, monitoring, and comparing cesarean section rates. The TGCS categorizes all women into ten mutually exclusive and totally inclusive groups based on five basic obstetric characteristics: parity, previous cesarean section, onset of labor, gestational age, and fetal presentation. This approach allows for meaningful comparisons within and across institutions, identification of the main contributors to cesarean rates, and evaluation of adherence to evidence-based clinical practice.
Studies worldwide consistently report that Groups 5 (previous cesarean, single cephalic, ≥37 weeks), 2 (nulliparous, induced or elective), and 1 (nulliparous, spontaneous labor) are the major contributors to rising C-section rates. In Egypt, substantial variation exists across hospitals, with facility-specific C-section rates ranging from 22.9% to 94.3%. Previous studies at Assiut University Hospital showed an increase from 32% in 2008 to 38% in 2011, yet comparative analyses across different institutions remain scarce.
This prospective cross-sectional survey will be conducted between January and December 2026 in Assiut University Hospital and Assiut General Hospital. All women delivering by cesarean section during the study period will be eligible, with exclusion of incomplete medical records or deliveries before 28 weeks. The estimated sample size is 770 cases, accounting for incomplete records. Data will be extracted using a standardized Robson-based form and entered electronically.
Primary outcomes include:
Distribution of cesarean deliveries across Robson groups
Comparison of C-section rates within Robson groups between hospitals
Contribution of each Robson group to the overall C-section rate
Secondary outcomes include:
Maternal outcomes (mortality, complications, ICU admission, postpartum hemorrhage, length of stay)
Neonatal outcomes (birth weight, Apgar score, NICU admission, perinatal complications)
Analysis of C-section indications within Robson groups
Identification of potentially avoidable cesarean deliveries
Assessment of adherence to clinical guidelines
Data analysis will be performed using SPSS v29.0. Statistical methods include descriptive analysis, chi-square tests, Fisher's exact tests, t-tests, logistic regression, and propensity score matching. A p-value <0.05 will be considered significant.
The results of this study will provide evidence on institutional differences in cesarean section practices in Assiut, inform local health policies, and support interventions aimed at optimizing the use of cesarean delivery to improve maternal and neonatal outcomes.
- Conditions
- Cesarean Section, Maternal Health
- Being tested
- No Intervention (subjects were previously treated with Onglyza®)
- Keywords
- Robson Ten Group Classification, Cesarean Section Rate, Maternal Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention (subjects were previously treated with Onglyza®)Other
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Deliveries in Assiut Hospitals | Women who delivered by cesarean section at Assiut University Hospital or Assiut General Hospital dur Receives: Other: No Intervention (subjects were previously treated with Onglyza®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of cesarean deliveries by Robson Ten Group Classification
Proportion of cesarean section deliveries categorized into the ten Robson groups, calculated as a percentage of total cesarean deliveries. The main objective is to identify the groups contributing most to the overall cesarean section rate.
Measured: January 2026 - December 2026
Secondary outcomes (1)
Comparison of cesarean section rates within Robson groups between hospitals
Rate and relative contribution of each Robson group will be compared between Assiut University Hospital and Assiut General Hospital.
Measured: January 2026 - December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Elzahraa salah Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194876
- Sponsor's protocol ID
- AUN-OBGYN-RobsonCS-2026
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
3. World Health Organization. Robson classification: implementation manual. Geneva: WHO; 2017.
Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.
PubMed 34130991Elnakib S, Abdel-Tawab N, Orbay D, Hassanein N. Medical and non-medical reasons for cesarean section delivery in Egypt: a hospital-based retrospective study. BMC Pregnancy Childbirth. 2019 Nov 8;19(1):411. doi: 10.1186/s12884-019-2558-2.
PubMed 31703638
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey Study Using the Ten-Group Robson Classification System to Evaluate Cesarean Section Rates and Maternal-Neonatal Outcomes in Assiut University Hospital and Assiut General Hospital
- ClinicalTrials.gov ID
- NCT07194876
- Acronym / sponsor ID
- AUN-OBGYN-RobsonCS-2026
- Conditions
- Cesarean Section, Maternal Health
- Keywords
- Robson Ten Group Classification, Cesarean Section Rate, Maternal Outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Sep 2025 (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.
Cesarean section (C-section) rates have increased worldwide, and Egypt is among the countries with the highest rates. In some hospitals, more than half of all births are done by cesarean delivery. The World Health Organization (WHO) recommends using the "Robson Ten Group Classification System" to better understand and compare C-section rates.
This study will use the Robson classification system to evaluate the rate of cesarean deliveries in two hospitals in Assiut, Egypt: Assiut University Hospital and Assiut General Hospital. The study will collect information from medical records of women who delivered by cesarean section between January and December 2026.
The main goal is to identify which groups of women contribute most to the high C-section rate and to compare practices between the two hospitals. The study will also look at outcomes for both mothers and newborns. By doing this, we hope to provide useful information that can help improve obstetric care, reduce unnecessary cesarean deliveries, and improve health outcomes for mothers and babies in Egypt.
Detailed description
Cesarean section (C-section) rates have risen dramatically worldwide, with Egypt showing one of the fastest increases, from 4.6% in 1992 to nearly 52% in 2014. Current national data indicate a rate of 51.8%, placing Egypt among the top three countries globally in C-section prevalence. This upward trend highlights an urgent need for systematic evaluation and targeted interventions.
In 2015, the World Health Organization (WHO) endorsed the Robson Ten Group Classification System (TGCS) as the international standard for assessing, monitoring, and comparing cesarean section rates. The TGCS categorizes all women into ten mutually exclusive and totally inclusive groups based on five basic obstetric characteristics: parity, previous cesarean section, onset of labor, gestational age, and fetal presentation. This approach allows for meaningful comparisons within and across institutions, identification of the main contributors to cesarean rates, and evaluation of adherence to evidence-based clinical practice.
Studies worldwide consistently report that Groups 5 (previous cesarean, single cephalic, ≥37 weeks), 2 (nulliparous, induced or elective), and 1 (nulliparous, spontaneous labor) are the major contributors to rising C-section rates. In Egypt, substantial variation exists across hospitals, with facility-specific C-section rates ranging from 22.9% to 94.3%. Previous studies at Assiut University Hospital showed an increase from 32% in 2008 to 38% in 2011, yet comparative analyses across different institutions remain scarce.
This prospective cross-sectional survey will be conducted between January and December 2026 in Assiut University Hospital and Assiut General Hospital. All women delivering by cesarean section during the study period will be eligible, with exclusion of incomplete medical records or deliveries before 28 weeks. The estimated sample size is 770 cases, accounting for incomplete records. Data will be extracted using a standardized Robson-based form and entered electronically.
Primary outcomes include:
Distribution of cesarean deliveries across Robson groups
Comparison of C-section rates within Robson groups between hospitals
Contribution of each Robson group to the overall C-section rate
Secondary outcomes include:
Maternal outcomes (mortality, complications, ICU admission, postpartum hemorrhage, length of stay)
Neonatal outcomes (birth weight, Apgar score, NICU admission, perinatal complications)
Analysis of C-section indications within Robson groups
Identification of potentially avoidable cesarean deliveries
Assessment of adherence to clinical guidelines
Data analysis will be performed using SPSS v29.0. Statistical methods include descriptive analysis, chi-square tests, Fisher's exact tests, t-tests, logistic regression, and propensity score matching. A p-value <0.05 will be considered significant.
The results of this study will provide evidence on institutional differences in cesarean section practices in Assiut, inform local health policies, and support interventions aimed at optimizing the use of cesarean delivery to improve maternal and neonatal outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean Deliveries in Assiut Hospitals | – | Other: No Intervention (subjects were previously treated with Onglyza®)Women who delivered by cesarean section at Assiut University Hospital or Assiut General Hospital dur |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women delivering by cesarean section at Assiut University Hospital and Assiut General Hospital in Assiut, Egypt, between January and December 2026. Data will be collected from medical records and classified using the Robson Ten Group Classification System.
Key inclusion criteria (3 listed)
- Women who delivered by cesarean section at Assiut University Hospital or Assiut General Hospital during the study period (January-December 2026).
- Gestational age ≥ 28 weeks.
- Complete medical records available.
Key exclusion criteria (3 listed)
- Vaginal deliveries.
- Cesarean deliveries before 28 weeks of gestation.
- Incomplete or missing medical records.
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 |
|---|---|---|
| No Intervention (subjects were previously treated with Onglyza®)no intervention | Other | Cesarean Deliveries in Assiut Hospitals |
Primary outcome
Distribution of cesarean deliveries by Robson Ten Group Classification
Time frame: January 2026 - December 2026
Proportion of cesarean section deliveries categorized into the ten Robson groups, calculated as a percentage of total cesarean deliveries. The main objective is to identify the groups contributing most to the overall cesarean section rate.
1 secondary outcome
Comparison of cesarean section rates within Robson groups between hospitals
Time frame: January 2026 - December 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Results publication3. World Health Organization. Robson classification: implementation manual. Geneva: WHO; 2017.
- Results publication: PubMed 34130991Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.
- Results publication: PubMed 31703638Elnakib S, Abdel-Tawab N, Orbay D, Hassanein N. Medical and non-medical reasons for cesarean section delivery in Egypt: a hospital-based retrospective study. BMC Pregnancy Childbirth. 2019 Nov 8;19(1):411. doi: 10.1186/s12884-019-2558-2.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Maternal Health, run by Assiut University.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact fatma salah sayed, resident (01004231328, thefreedomeizahraa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of cesarean deliveries by Robson Ten Group Classification (time frame: January 2026 - December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194876, which also lists 3 linked publications.
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 26 Sep 2025.