Risk Factors for Primary Cesarean Section in Egypt | NCT03905980

Studies
Risk Factors for Primary Cesarean Section in Egypt

NCT03905980

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 26, 2019Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Cesarean Section

Interventions

vaginal delivery
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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

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

Apr 30, 2019Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Apr 4, 2019

First Submission Date that Met QC Criteria

Apr 4, 2019

First Posted Date

Apr 8, 2019Actual

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

Jul 24, 2019

Last Update Posted Date

Jul 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery

Detailed Description

Evaluation of maternal , fetal, delivery place and health care provider rules to determine route of delivery in women during their first pregnancy

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

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal delivery		woman who terminate their pregnancy by vaginal delivery	Procedure: vaginal delivery
Cesarean delivery		woman who terminate their pregnancy by cesarean delivery	Procedure: Cesarean section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaginal delivery	Procedure	pregnancy ended by vaginal delivery	Vaginal delivery

Measure	Description	Time Frame
route of delivery in primigravida		at delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women in their first pregnancy
Delivery between 37 and 42 weeks
Singleton pregnancy _ cephalic presentation

Exclusion Criteria:

women asked for CS on demand

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

woman carrying their first pregnancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Maged, MD	Contact	+201005227404		prof.ahmedmaged@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed Maged, MD	Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school	Recruiting	Cairo		12151	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

Intervention Browse Module

MeSH Terms

ID	Term
D002585	Cesarean Section

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

Not provided