Modified Cervical Inversion During CS in Placenta Previa | NCT03772184

Studies
Modified Cervical Inversion During CS in Placenta Previa

NCT03772184

Sponsor

Aljazeera Hospital

Status

Completed

Last Update Posted

Feb 22, 2022Actual

Enrollment

240Actual

Phase

Not Applicable

Conditions

Placenta Previa

Interventions

Cervical inversion

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

Feb 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

Jan 10, 2019Actual

Primary Completion Date

May 12, 2019Actual

Completion Date

May 15, 2019Actual

First Submitted Date

Dec 10, 2018

First Submission Date that Met QC Criteria

Dec 10, 2018

First Posted Date

Dec 11, 2018Actual

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

Feb 20, 2022

Last Update Posted Date

Feb 22, 2022Actual

Name	Class
Suez Canal University	OTHER

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cervical inversion	Active Comparator		Procedure: Cervical inversion
no cervical inversion	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cervical inversion	Procedure	inverting the cervical lip after delivery	cervical inversion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion	how can the cervical inversion technique controls the placental bed bleeding	within an hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women 38 weeks or more with placenta previa

Exclusion Criteria:

pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women with placenta previa

Minimum Age

22 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	National research centre , Aljazeerah hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah and helwan university		Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010923	Placenta Previa

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided