Complications; Cesarean SectionNCT02785094
Education and Social Media Versus Non-Indicated Caesarean Section Rate in Egypt
An observational study of Complications; Cesarean Section, run by Talkha Central Hospital at 1 site in Egypt.
Trial summary
This study focus on measuring effect of Egyptian Primigravidas' education level and accessibility to social media on rate of maternal request option offered for non-indicated primary caesarean section. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,400 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to Sep 2016
- 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
- No healthy volunteers
- Adult
Study population: Primigravidas whom been carefully counselled, and the overall risks and benefits of caesarean section and vaginal birth, and IOL for prolonged pregnancy discussed with.
Who may be able to join
- Full term with gestational age (G.A) more than or equal 39 weeks.
- Acceptance to answer study short questionnaire to determine eligible participants for each cohort.
Who cannot join
- Multiparity.
- History of previous Caesarean Section/s.
- Any Mental or Physical disabilities.
- Disapproval for answering a predefined short questionnaire related to study.
Trial locations and contacts
1 site in 1 country.
About this study
This study focus on measuring effect of Egyptian Primigravidas' education level and accessibility to social media on rate of maternal request option offered for non-indicated primary caesarean section.
Read the detailed description
A caesarean section (CS) is a life-saving surgical procedure when certain complications arise during pregnancy and labour. However, it is a major surgery and is associated with immediate maternal and perinatal risks and may have implications for future pregnancies as well as long-term effects that are still being investigated. The use of CS has increased dramatically worldwide in the last decades particularly in middle- and high-income countries, and some studies showing a link between increasing CS rates and poorer outcomes, and reasons for this increase are multifactorial and not well-understood.
In Egypt the CS rate according to WHO (World Health Organization),Health report (2010) is 27.6 %. Egypt also is considered to be the highest African country in CS rate (51.8 %), in which CS rate rose from 4.6 % to 51.8 % over the 24 year period (1990-2014), and more than half of all women give birth by CS in Egypt without much difference between urban and rural areas.
Slightly more than half of the live births in the five-year period before 2014 Egypt Demographic and Health survey were by CS, and 60 % of primigravidas delivered by CS.
Updated indications of primary CS including option of maternal request as one of these indications were reported in both RCOG (Royal College of Obstetricians and Gynaecologists) Press report (2001) and RCOG CS various guidelines.
Recently, the Egyptian public opinion deviated to obstetricians' desire for self financial benefits to be the major cause of increasing Egypt CS rates; depending on newspaper articles and social media talks.
- Conditions
- Complications; Cesarean Section
- Being tested
- Observation
- Keywords
- Caesarean Section Rate, Primigravida
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
Observation of Participants' behaviour
| Study group | Role | What they receive |
|---|---|---|
| A | Group of High Education level Receives: Behavioral: Observation | |
| B | Group of Low/Non Education level Receives: Behavioral: Observation | |
| C | Group has Accessibility to Social Media Receives: Behavioral: Observation | |
| D | Group has not Accessibility to Social Media Receives: Behavioral: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Primigravidas who request a Non-Indicated CS
Number of Primigravidas who request a Non-Indicated CS.
Measured: Up to 2 weeks
Secondary outcomes (1)
Number of Primigravidas who refused to have a trial of IOL (Induction of Labour), as an index for deviated intention to request a Non-Indicated CS
Number of Primigravidas who refused to have a trial of IOL (Induction of Labour), as an index for deviated intention to request a Non-Indicated CS.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
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 Complications; Cesarean SectionStudies 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
- Prospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talkha Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amro Mohamed Ibrahim Ibrahim Hetta, Talkha Central Hospital
- Investigators
- Amro M Hetta, M.B., Ch.B., Principal investigator, Talkha Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785094
- Sponsor's protocol ID
- OG3
- Status last verified
- Sep 2016
- First submitted
- 23 May 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801Gibbons L, Belizán JM, Lauer JA, Betrán AP, Merialdi M, Althabe F. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. World health report 2010, 30: 1-31.
Ministry of Health and Population [Egypt], El-Zanaty and Associates [Egypt], and ICF International. 2015. Egypt Demographic and Health Survey 2014. Cairo, Egypt and Rockville, Maryland, USA: Ministry of Health and Population and ICF International.
Thomas J, Paranjothy S. Royal College of Obstetricians and Gynaecologists Clinical Effectiveness Support Unit. National Sentinel Caesarean Section Audit Report. London: RCOG press; 2001.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education and Social Media Versus Non-Indicated Caesarean Section Rate in Egypt
- ClinicalTrials.gov ID
- NCT02785094
- Acronym / sponsor ID
- OG3
- Conditions
- Complications; Cesarean Section
- Keywords
- Caesarean Section Rate, Primigravida
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Talkha Central HospitalOther government
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- 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 study focus on measuring effect of Egyptian Primigravidas' education level and accessibility to social media on rate of maternal request option offered for non-indicated primary caesarean section.
Detailed description
A caesarean section (CS) is a life-saving surgical procedure when certain complications arise during pregnancy and labour. However, it is a major surgery and is associated with immediate maternal and perinatal risks and may have implications for future pregnancies as well as long-term effects that are still being investigated. The use of CS has increased dramatically worldwide in the last decades particularly in middle- and high-income countries, and some studies showing a link between increasing CS rates and poorer outcomes, and reasons for this increase are multifactorial and not well-understood.
In Egypt the CS rate according to WHO (World Health Organization),Health report (2010) is 27.6 %. Egypt also is considered to be the highest African country in CS rate (51.8 %), in which CS rate rose from 4.6 % to 51.8 % over the 24 year period (1990-2014), and more than half of all women give birth by CS in Egypt without much difference between urban and rural areas.
Slightly more than half of the live births in the five-year period before 2014 Egypt Demographic and Health survey were by CS, and 60 % of primigravidas delivered by CS.
Updated indications of primary CS including option of maternal request as one of these indications were reported in both RCOG (Royal College of Obstetricians and Gynaecologists) Press report (2001) and RCOG CS various guidelines.
Recently, the Egyptian public opinion deviated to obstetricians' desire for self financial benefits to be the major cause of increasing Egypt CS rates; depending on newspaper articles and social media talks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: ObservationGroup of High Education level |
| B | – | Behavioral: ObservationGroup of Low/Non Education level |
| C | – | Behavioral: ObservationGroup has Accessibility to Social Media |
| D | – | Behavioral: ObservationGroup has not Accessibility to Social Media |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primigravidas whom been carefully counselled, and the overall risks and benefits of caesarean section and vaginal birth, and IOL for prolonged pregnancy discussed with.
Key inclusion criteria (2 listed)
- Full term with gestational age (G.A) more than or equal 39 weeks.
- Acceptance to answer study short questionnaire to determine eligible participants for each cohort.
Key exclusion criteria (4 listed)
- Multiparity.
- History of previous Caesarean Section/s.
- Any Mental or Physical disabilities.
- Disapproval for answering a predefined short questionnaire related to study.
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 |
|---|---|---|
| ObservationObservation of Participants' behaviour | Behavioural | A, B, C, D |
Primary outcome
Number of Primigravidas who request a Non-Indicated CS
Time frame: Up to 2 weeks
Number of Primigravidas who request a Non-Indicated CS.
1 secondary outcome
Number of Primigravidas who refused to have a trial of IOL (Induction of Labour), as an index for deviated intention to request a Non-Indicated CS
Time frame: Up to 24 hours
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 7 Sep 2016.
- Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- BackgroundGibbons L, Belizán JM, Lauer JA, Betrán AP, Merialdi M, Althabe F. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. World health report 2010, 30: 1-31.
- BackgroundMinistry of Health and Population [Egypt], El-Zanaty and Associates [Egypt], and ICF International. 2015. Egypt Demographic and Health Survey 2014. Cairo, Egypt and Rockville, Maryland, USA: Ministry of Health and Population and ICF International.
- BackgroundThomas J, Paranjothy S. Royal College of Obstetricians and Gynaecologists Clinical Effectiveness Support Unit. National Sentinel Caesarean Section Audit Report. London: RCOG press; 2001.
- 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.
Amro M Hetta, M.B., Ch.B. principal investigator
Talkha Central Hospital
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 Complications; Cesarean Section, run by Talkha Central Hospital 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 2 inclusion and 4 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 7 Sep 2016. 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?
Number of Primigravidas who request a Non-Indicated CS (time frame: Up to 2 weeks). 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 NCT02785094, 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 7 Sep 2016.