NCT06502119

Brief Summary

The goal of this observational study is to evaluate the knowledge, attitudes, and practices of operative vaginal birth among obstetric providers in Egypt. The main questions it aims to answer are:

  • What is the level of knowledge among obstetric providers regarding operative vaginal birth?
  • What are the attitudes and practices of obstetric providers towards operative vaginal birth? Participants will:
  • Complete a detailed questionnaire assessing their knowledge, attitudes, and practices related to operative vaginal birth.
  • Provide demographic information to contextualize their responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 27, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

July 20, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

June 27, 2024

Last Update Submit

July 1, 2025

Conditions

Keywords

Operative ForcepsVaginal birthBirth injuries

Outcome Measures

Primary Outcomes (4)

  • Knowledge of Operative Vaginal Birth Among Obstetric Providers

    The level of knowledge regarding operative vaginal birth among obstetric providers, assessed using a validated questionnaire. The knowledge score will be based on correct responses to a series of questions about indications, techniques, benefits, and risks associated with operative vaginal birth.

    Within 6 months of study commencement.

  • Attitudes Toward Operative Vaginal Birth Among Obstetric Providers

    The attitudes of obstetric providers towards operative vaginal birth, measured using a Likert scale in the validated questionnaire. Providers will rate their agreement with statements related to their perceptions and opinions on the use of operative vaginal birth.

    Within 6 months of study commencement.

  • Practices of Operative Vaginal Birth Among Obstetric Providers

    The frequency and context of operative vaginal birth practices among obstetric providers, as reported in the validated questionnaire. This measure will include the number of operative vaginal births performed, preferred techniques, and any barriers to performing these procedures.

    Within 6 months of study commencement.

  • Rate of Cesarean Sections Among Participants

    The percentage of Cesarean sections performed by the obstetric providers participating in the study, as reported in the validated questionnaire. This measure aims to correlate knowledge, attitudes, and practices with the actual rate of Cesarean sections.

    Within 6 months of study commencement.

Study Arms (1)

Health Provider

The study will include obstetricians and gynecologists practicing in Egypt. These healthcare professionals specialize in the management of pregnancy, childbirth, and women's reproductive health. Participants will be recruited from various healthcare settings, including public and private hospitals, ensuring a diverse representation of clinical experiences and perspectives on operative vaginal birth practices. All participants must actively engage in obstetric care and possess direct experience with operative vaginal births, allowing for an in-depth exploration of their knowledge, attitudes, and practices related to this procedure within the Egyptian healthcare context.

Other: Designed Questionnaire

Interventions

Participants in this study, comprised solely of obstetricians and gynecologists practicing in Egypt, will complete a self-administered questionnaire designed to assess their knowledge, attitudes, and practices related to operative vaginal birth. The questionnaire includes four sections: the first gathers demographic data such as name, gender, and years of experience in childbirth care; the second focuses on participants' practices regarding the frequency and types of operative vaginal birth used (forceps, ventouse) and reasons for their use; the third evaluates knowledge of outcomes associated with operative vaginal birth through multiple-choice questions; and the fourth explores attitudes towards operative vaginal birth, including opinions on hospital rates and policy appropriateness. Completion and return of the questionnaire, which takes approximately 5 to 10 minutes, will be considered as consent to participate in the study.

Health Provider

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study focuses exclusively on obstetricians and gynecologists practicing in Egypt. These healthcare professionals are actively involved in providing obstetric care and have direct experience with operative vaginal births. Participants will be recruited from various healthcare settings, including public and private hospitals, ensuring a diverse representation of clinical perspectives and experiences across different practice environments within Egypt.

You may qualify if:

  • Licensed Obstetricians: Only obstetricians who are currently licensed to practice in Egypt.
  • Active Practice: Obstetricians who are actively practicing in hospitals or clinics in Egypt.
  • Experience: Obstetricians with a minimum of one year of experience in obstetrics and gynecology.
  • Consent: Willingness to participate and provide informed consent.
  • Language: Ability to understand and complete the questionnaire in English.

You may not qualify if:

  • Non-Obstetricians: Healthcare providers who are not obstetricians.
  • Inactive Practice: Obstetricians who are not currently practicing in Egypt.
  • Insufficient Experience: Obstetricians with less than one year of experience in the field.
  • Non-Consent: Individuals who do not provide informed consent to participate in the study.
  • Language Barrier: Obstetricians who are unable to understand and complete the questionnaire in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty od Medicine, Department of Obstetrics and Gynecology.

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Pregnancy ComplicationsBirth Injuries

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer and consultant at Obstetrics and Gynecology Department.

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 16, 2024

Study Start

July 20, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

As part of this study, Individual Participant Data (IPD) will be shared to facilitate transparency and enable further research in the field of operative vaginal birth practices among obstetricians and gynecologists in Egypt. De-identified IPD will include demographic information, responses from the questionnaire assessing knowledge, attitudes, and practices related to operative vaginal birth, and any additional data pertinent to the study outcomes. Access to the IPD will be granted to researchers with approved proposals demonstrating scientific merit and ethical approval. Data will be made available through a secure, encrypted transfer mechanism, and all users will be required to sign a Data Use Agreement (DUA) outlining terms for responsible data use and confidentiality.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data collection for the study will commence on \[1, July, 2014\] and conclude by \[30, October, 2024\]. IPD will be accessible for sharing beginning \[30, December, 2024\] and will remain available for a period of \[2 years\] following publication of primary study results.
Access Criteria
Access to IPD will be granted to researchers with scientifically sound proposals aimed at advancing knowledge in the field of operative vaginal birth practices among obstetricians and gynecologists in Egypt. Proposals must include evidence of ethical approval from an institutional review board or equivalent ethics committee. Researchers affiliated with recognized academic, medical, or research institutions will be eligible. Access requests will be evaluated based on the scientific merit of the proposal, feasibility of the research aims, and potential contribution to improving health outcomes. All users must sign a Data Use Agreement (DUA) ensuring confidentiality, ethical data use, and prohibiting attempts to re-identify participants.

Locations