Indication of Ceaseran Section in Primigravida According... | NCT03967028

Studies
Indication of Ceaseran Section in Primigravida According to Robson's Classification

NCT03967028

Sponsor

Assiut University

Status

Completed

Last Update Posted

May 9, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

CESAREAN SECTION

Interventions

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

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2019Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

May 26, 2019

First Submission Date that Met QC Criteria

May 26, 2019

First Posted Date

May 30, 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

May 6, 2022

Last Update Posted Date

May 9, 2022Actual

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

Rate of caesarean section surgery are rising worldwide,but the determinant of this increase,especially in low-income and middle-income countries, are controversial.In 1985,The world Health organization (WHO) stated;(There is no justification for any region to have a ceasearan section rate higher than 10-15%). Despite the lack of scientific evidence indicating any substantial maternal and perinatal benefits from increasing cs rates,and some studies showing that higher rates could be linked to negative consequences in maternal and child health, CS continue to increase world wide

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		primigravida scheduled for cesarean section	Procedure: cesarean section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cesarean section	Procedure	lower segment cesarean section either elective or emergency	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of etiologies of cesarean section	determine the rate of cesarean section with different indication according to Robson classification	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nullipara
Single fetus .
More than 37 weeks .
Patients who pass into spontaneous
Patient who induced labour

Exclusion Criteria:

Non cephalic presentation.
Abnormal lie

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant women admitted to women health hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

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

Not provided

Browse Branches

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