Effect of Multiple Repeat Cesarean Sections on Intra-abdo... | NCT03261765

Studies
Effect of Multiple Repeat Cesarean Sections on Intra-abdominal Adhesions

NCT03261765

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jun 27, 2018Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Cesarean Section Complications

Interventions

Assessment of adhesions

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

Jun 2018

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

Jun 1, 2018Actual

Primary Completion Date

Aug 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Aug 23, 2017

First Submission Date that Met QC Criteria

Aug 23, 2017

First Posted Date

Aug 25, 2017Actual

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

Jun 26, 2018

Last Update Posted Date

Jun 27, 2018Actual

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

The rate of cesarean section deliveries has increased dramatically worldwide in the last decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to 2007 data and is thought to be over 50% at present. The reasons for this include advanced age of primigravida, a wide range of indications, patient requests, the frequency of women with previous cesareans, women's rejections to offers of sterilization, and the common usage of assisted reproductive techniques

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

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiple repeat cesarean (four or more)			Other: Assessment of adhesions
Fewer repeat cesarean (two-three)			Other: Assessment of adhesions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of adhesions	Other	Modified Nair scoring system	Fewer repeat cesarean (two-three) Multiple repeat cesarean (four or more)

Measure	Description	Time Frame
Rate of abdominal adhesions		30 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with at least previous one cesarean section.
Women accepted to participate in the study.

Exclusion Criteria:

Previous abdominopelvic surgery other than cesarean section.
History of Pelvic inflammatory disease.
Women refuse to participate in the study.
Intrauterine fetal death

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

All women with repeated cesarean section

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Abbas	Contact	01003385183		bmr90@hotmail.com
Ahmed Abbas	Contact

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided