Education and Social Media Versus Non-Indicated Caesarean Section Rate in Egypt

Complications; Cesarean Section Clinical Trial

Official title:

Education and Social Media Versus Non-Indicated Caesarean Section Rate in Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785094
• Other study ID #: OG3
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: September 2, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Talkha Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Multiparity.

• History of previous Caesarean Section/s.

• Any Mental or Physical disabilities.

• Disapproval for answering a predefined short questionnaire related to study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complications; Cesarean Section

Intervention

Behavioral:
• Observation
Observation of Participants' behaviour

Locations

Country	Name	City	State
Egypt	Talkha Central Hospital	Mansoura	Al-Dakahliya

Sponsors (1)

Lead Sponsor	Collaborator
Talkha Central Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Betrán AP, Ye J, Moller AB, Zhang J, Gülmezoglu 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. — View Citation

Gibbons 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Primigravidas who request a Non-Indicated CS	Number of Primigravidas who request a Non-Indicated CS.	Up to 2 weeks	Yes
Secondary	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.	Up to 24 hours	Yes