Role of Drain in Decreasing Postoperative Complications | NCT04287933

Studies
Role of Drain in Decreasing Postoperative Complications

NCT04287933

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Feb 27, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cesarean Section Complications

Interventions

Drain insertion

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 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2020Estimated

Primary Completion Date

Jul 3, 2020Estimated

Completion Date

Aug 10, 2020Estimated

First Submitted Date

Feb 26, 2020

First Submission Date that Met QC Criteria

Feb 26, 2020

First Posted Date

Feb 27, 2020Actual

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 26, 2020

Last Update Posted Date

Feb 27, 2020Actual

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drain	Active Comparator		Device: Drain insertion
No drain	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drain insertion	Device	insertion of a drain	Drain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of women who will have complications	How many women who will have complications postoperative	within 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women undergoing cesarean section

Exclusion Criteria:

Women who deliver by normal vaginal delivery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women who will have complications after cesarean sectin

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy, PhD	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	Algezeera hospitaland National Research Centre ,Egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah		Giza			Egypt	Mahmoud Alalfy, master