Placenta Accreta&Its Complications in Placenta Previa Cases | NCT02606474

Studies
Placenta Accreta&Its Complications in Placenta Previa Cases

NCT02606474

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Nov 17, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Placenta Accreta in Placenta Previa Anterior

Interventions

Not provided

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

Nov 2015

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

Nov 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Nov 7, 2015

First Submission Date that Met QC Criteria

Nov 13, 2015

First Posted Date

Nov 17, 2015Estimated

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

Nov 13, 2015

Last Update Posted Date

Nov 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta accreta is diagnosed during cesarean section &confirmed by pathology. All complications are monitored in cases with placenta accreta and without.

Detailed Description

100 cases of gestational age 30 weeks or more with placenta previa anterior with previous one or more cesarean section will be enrolled. History,examination &routine investigations will be taken. Colour doppler will be done to diagnose cases with suspected placenta accreta. Pre & postoperative Hb concentration will be taken. Cases with nonseparation of the placenta will be diagnosed as accreta & confirmed by pathology. Operative time & complications like bladder or intestinal injury will be noted. All data will be analyzed.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with placenta accreta.		3 months
Number of patients with bladder injury.		3 months
Number of patients with intestinal injury.		3 months
Number of patients with cesarean hysterectomy.		3 months
Number of deaths.		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all pregnant women more than 30 weeks with previous one or more cesarean section with placenta previa anterior

Exclusion Criteria:

pregnant with unscarred uterus
scars other than cesarean section

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 with gestational age more than 30 weeks with previous one or more cesarean section with placenta previa anterior

Sampling Method

Probability Sample