Primary Cesarean Section in Primigravida and Muligravida... | NCT06083727

Studies
Primary Cesarean Section in Primigravida and Muligravida in Sohag and Al Balyana Cities

NCT06083727

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Oct 16, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Primary Cesarean Section

Interventions

rate of cesarean section

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 24, 2023Actual

Primary Completion Date

Mar 24, 2024Estimated

Completion Date

Mar 24, 2024Estimated

First Submitted Date

Oct 9, 2023

First Submission Date that Met QC Criteria

Oct 9, 2023

First Posted Date

Oct 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2023

Last Update Posted Date

Oct 16, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sahar Nasser Fathy, resident at obstetric and gynacology department at sohag university hospial, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

cesarean section and vaginal delivery are two methods of delivery, cesarean section somtimes indicated for obstetrical reason but primary cesarean section especially in primigravida might have a preference of the mode of delivery

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
primigravida			Other: rate of cesarean section
multigravida			Other: rate of cesarean section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rate of cesarean section	Other	rate of primary cesarean section in primigravida and multigravida	multigravida primigravida

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate	rate of primary cesarean section	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all primigravida with gestational age more than 28 weeks and above who have come for delivery
multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery
women between 18 and 45 years

Exclusion Criteria:

primigravida women <28 weeks
multigravida <28 weeks
patient having previous history of myomectomy or hystrotomy
gravida 5 and more

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

all primigravida with gestational age more than 28 weeks and above who have come for delivery

multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery
women between 18 and 45 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sahar N Fathy, resident	Contact	01146577899		sahernasser@med.sohag.com
Salah M Rasheed, professor	Contact	01224653702

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university	Recruiting	Sohag		Sohag	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 12, 2024
Reset	Oct 10, 2024

Submission Tracking

Estimated Results First Submitted Date

Jul 12, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 12, 2024			Oct 10, 2024