Prediction of Intra-abdominal Adhesion Before CS | NCT03800511

Studies
Prediction of Intra-abdominal Adhesion Before CS

NCT03800511

Sponsor

Nahed allam

Status

Unknown status

Last Update Posted

Jan 14, 2019Actual

Enrollment

27Estimated

Phase

Not provided

Conditions

Intra-Abdominal; Adhesion

Interventions

sliding test

Countries

Not provided

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

Jan 2019

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 2019Estimated

Primary Completion Date

Aug 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Jan 9, 2019

First Submission Date that Met QC Criteria

Jan 9, 2019

First Posted Date

Jan 11, 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

Jan 10, 2019

Last Update Posted Date

Jan 14, 2019Actual

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

Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients.

Detailed Description

the repeated cesarean section is associated with recorded maternal morbidity including placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular injuries. The anticipation of the problem is important for decreasing its adverse effect . preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall, bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior staff obstetrician or others and theatre requirements to overcome any problem happened.

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

27Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
repeated caesarean section		full term pregnant women with singleton baby with a history of at least previous one caesarean section	Diagnostic Test: sliding test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sliding test	Diagnostic Test	ultrasound detected sliding test before doing repeated caesarean section	repeated caesarean section

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intra-abdominal adhesion	presence of adhesion between uterus and abdominal wall or intestine on bladder	intra-operative period

Secondary Outcomes

Measure	Description	Time Frame
skin to uterine incision time	time consumed by surgeon from skin incision to uterine incision in minutes	intra-operative period
need to insert intra-peritoneal drain	if there in marked adhesion and vascular injury a drain could be inserted

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant in their 9th-month singleton, planned for elective CS and had a history of previous CS

Exclusion Criteria:

included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of CS

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

pregnant women in their 9th-month singleton planned for elective repeated CS and had a history of previous CS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
nahed allam, MD	Contact	+0201121116136		nahedallam16@gmail.com

Overall Officials

Name	Affiliation	Role
Taiseer Maarouf, MD	Al-Azhar University	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

It is not yet known if there will be a plan to make IPD available.discussion with the other authors after completion of recruitment of patients

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000267	Tissue Adhesions

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided