NCT06622733

Brief 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 . 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 29, 2024

Last Update Submit

September 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Women's interest in caesarean section

    Questionnaire to inform women about benefits and risks of CS

    6 months

Interventions

QuestionnaireBEHAVIORAL

Attitude towards the concept of CS on demand

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women attending the antenatal care clinic of Sohag University hospital

You may qualify if:

  • pregnant women attending the antenatal care clinic of Sohag University hospital

You may not qualify if:

  • postmenopausal women
  • women with previous two or more cs
  • women refusing to participate in the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 16650356BACKGROUND
  • Betran 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.

    PMID: 26681211BACKGROUND
  • Martin 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.

    PMID: 22670489BACKGROUND
  • Abbaspoor 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.

    PMID: 23870747BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Mohamed A Khalifa, Resident

CONTACT

Yasser A Helmy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Residence at gyn and OBS department

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 2, 2024

Study Start

September 28, 2024

Primary Completion

March 30, 2025

Study Completion

September 30, 2025

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations