CsNCT06622733
Attitude Towards the Concept of CS on Demand
An observational study of Cs, run by Sohag University at 1 site in Egypt.
Trial summary
Caesarean section (CS) is a surgical procedure performed to facilitate delivery of the baby through an incision made on the mother's abdomen. Ideally, it is recommended in situations where normal vaginal delivery (VD) can pose risks to either the mother baby or both . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cs
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2024to 30 Sep 2025
- 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 18 to 45 years
- Women only
- Adult
Study population: Pregnant women attending the antenatal care clinic of Sohag University hospital
Who may be able to join
- pregnant women attending the antenatal care clinic of Sohag University hospital
Who cannot join
- postmenopausal women
- women with previous two or more cs
- women refusing to participate in the questionnaire
Trial locations and contacts
1 site in 1 country.
Yasser A Helmy, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Magdy M Amin, Professor
About this study
Official title: Attitude Towards the Concept of Cesarean Section on Demand Among a Random Sample of Pregnant Women Attending the Antenatal Care Clinic of Sohag University Hospital
Caesarean section (CS) is a surgical procedure performed to facilitate delivery of the baby through an incision made on the mother's abdomen. Ideally, it is recommended in situations where normal vaginal delivery (VD) can pose risks to either the mother baby or both . In the western world women have only one or two children, while in the East or the Middle East, women are culturally coerced into having many children. Thus, they are more prone to multiple Cesarean deliveries in their lifetime [1.2]. ThisAccording to the World Health Organization (WHO), since 1985, the acceptable percentage of worldwide C-sections has been 10-15% of all deliveries [3]. One of the most critical findings of the American Center for Disease Control and Prevention found that the Cesarean delivery rate has increased from 20.7% in 1995 to 31.6% in 2016 [4 ]. It is important to mention that Cesarean deliveries are life-saving procedures when there are obstetrical indications.(5.6) Cesarean delivery indications include fetal malpresentation, multiple pregnancies, chorioamnionitis, arrested labour, oligohydramnios, cord prolapse, cephalo-pelvic disorders, and medical diseases such as eclampsia and HELPP (hemolysis, elevated liver enzymes, and low platelets) syndrome .the number of patients undergoing Cesarean delivery for non-obstetric reasons has rapidly increased. This could be due to many factors influencing the patients' decisions, including possible fetal outcomes concerning beliefs in some cultures and the convenience of patients and obstetricians(7) .cesarean section on demand allows a woman to choose a cesarean section without a medical reason, based solely on her personal preference Five themes that reflected the reasons for elective cesarian birth without medical indication were identified: (1) fear of vaginal birth process, (2) concerns about future sexual life, (3) need for humanized birth, (4) personal reasons, and (5) decision-making process.(8) raising the awareness of providers about the appropriate indications for CS and the importance of advocating for vaginal delivery among eligible women - including those with a previous CScan trigger practice changes that may reduce the incidence of non-medically indicated caesarean delivery
- Conditions
- Cs
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Attitude towards the concept of CS on demand
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's interest in caesarean section
Questionnaire to inform women about benefits and risks of CS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start28 Sep 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Khalifa Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622733
- Sponsor's protocol ID
- Soh-Med-24-09---12MS
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sobande A, Eskandar M. Multiple repeat caesarean sections: complications and outcomes. J Obstet Gynaecol Can. 2006 Mar;28(3):193-197. doi: 10.1016/S1701-2163(16)32105-3.
PubMed 16650356Betran AP, Torloni MR, Zhang JJ, Gulmezoglu AM; WHO Working Group on Caesarean Section. WHO Statement on Caesarean Section Rates. BJOG. 2016 Apr;123(5):667-70. doi: 10.1111/1471-0528.13526. Epub 2015 Jul 22. No abstract available.
PubMed 26681211Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, Wilson EC. Births: final data for 2009. Natl Vital Stat Rep. 2011 Nov 3;60(1):1-70.
PubMed 22670489Abbaspoor Z, Moghaddam-Banaem L, Ahmadi F, Kazemnejad A. Iranian mothers' selection of a birth method in the context of perceived norms: a content analysis study. Midwifery. 2014 Jul;30(7):804-9. doi: 10.1016/j.midw.2013.06.003. Epub 2013 Jul 17.
PubMed 23870747
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitude Towards the Concept of Cesarean Section on Demand Among a Random Sample of Pregnant Women Attending the Antenatal Care Clinic of Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06622733
- Acronym / sponsor ID
- Soh-Med-24-09---12MS
- Conditions
- Cs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Oct 2024 (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.
Caesarean section (CS) is a surgical procedure performed to facilitate delivery of the baby through an incision made on the mother's abdomen. Ideally, it is recommended in situations where normal vaginal delivery (VD) can pose risks to either the mother baby or both . In the western world women have only one or two children, while in the East or the Middle East, women are culturally coerced into having many children. Thus, they are more prone to multiple Cesarean deliveries in their lifetime [1.2]. ThisAccording to the World Health Organization (WHO), since 1985, the acceptable percentage of worldwide C-sections has been 10-15% of all deliveries [3]. One of the most critical findings of the American Center for Disease Control and Prevention found that the Cesarean delivery rate has increased from 20.7% in 1995 to 31.6% in 2016 [4 ]. It is important to mention that Cesarean deliveries are life-saving procedures when there are obstetrical indications.(5.6) Cesarean delivery indications include fetal malpresentation, multiple pregnancies, chorioamnionitis, arrested labour, oligohydramnios, cord prolapse, cephalo-pelvic disorders, and medical diseases such as eclampsia and HELPP (hemolysis, elevated liver enzymes, and low platelets) syndrome .the number of patients undergoing Cesarean delivery for non-obstetric reasons has rapidly increased. This could be due to many factors influencing the patients' decisions, including possible fetal outcomes concerning beliefs in some cultures and the convenience of patients and obstetricians(7) .cesarean section on demand allows a woman to choose a cesarean section without a medical reason, based solely on her personal preference Five themes that reflected the reasons for elective cesarian birth without medical indication were identified: (1) fear of vaginal birth process, (2) concerns about future sexual life, (3) need for humanized birth, (4) personal reasons, and (5) decision-making process.(8) raising the awareness of providers about the appropriate indications for CS and the importance of advocating for vaginal delivery among eligible women - including those with a previous CScan trigger practice changes that may reduce the incidence of non-medically indicated caesarean delivery
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women attending the antenatal care clinic of Sohag University hospital
Key inclusion criteria (1 listed)
- pregnant women attending the antenatal care clinic of Sohag University hospital
Key exclusion criteria (3 listed)
- postmenopausal women
- women with previous two or more cs
- women refusing to participate in the questionnaire
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 |
|---|---|---|
| QuestionnaireAttitude towards the concept of CS on demand | Behavioural | – |
Primary outcome
Women's interest in caesarean section
Time frame: 6 months
Questionnaire to inform women about benefits and risks of CS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 16650356Sobande A, Eskandar M. Multiple repeat caesarean sections: complications and outcomes. J Obstet Gynaecol Can. 2006 Mar;28(3):193-197. doi: 10.1016/S1701-2163(16)32105-3.
- Background: PubMed 26681211Betran AP, Torloni MR, Zhang JJ, Gulmezoglu AM; WHO Working Group on Caesarean Section. WHO Statement on Caesarean Section Rates. BJOG. 2016 Apr;123(5):667-70. doi: 10.1111/1471-0528.13526. Epub 2015 Jul 22. No abstract available.
- Background: PubMed 22670489Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, Wilson EC. Births: final data for 2009. Natl Vital Stat Rep. 2011 Nov 3;60(1):1-70.
- Background: PubMed 23870747Abbaspoor Z, Moghaddam-Banaem L, Ahmadi F, Kazemnejad A. Iranian mothers' selection of a birth method in the context of perceived norms: a content analysis study. Midwifery. 2014 Jul;30(7):804-9. doi: 10.1016/j.midw.2013.06.003. Epub 2013 Jul 17.
- 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. This study is not recruiting at the moment.
Yasser A Helmy, Professor contact
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 Cs, run by Sohag 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 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Khalifa, Resident (01140103255, mohamed.khalifa2015@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's interest in caesarean section (time frame: 6 months). 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 NCT06622733, which also lists 4 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 2 Oct 2024.