Remnants of Conception After Suction Evacuation of Missed... | NCT03813849

Studies
Remnants of Conception After Suction Evacuation of Missed Abortion

NCT03813849

Sponsor

University of Alexandria

Status

Unknown status

Last Update Posted

Oct 28, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Miscarriage

Interventions

Sonographic examination of uterus after surgical evacuation

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

Oct 2019

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 10, 2016Actual

Primary Completion Date

Jan 30, 2020Estimated

Completion Date

Mar 30, 2020Estimated

First Submitted Date

Apr 9, 2018

First Submission Date that Met QC Criteria

Jan 22, 2019

First Posted Date

Jan 23, 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

Oct 25, 2019

Last Update Posted Date

Oct 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mervat Sheikhelarab Elsedeek Ibrahim Omran, professor of obstetrics and gynecology, University of AlexandriaPrincipal Investigator

Lead Sponsor

University of AlexandriaOTHER

Collaborators

Not provided

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

All women admitted for surgical evacuation of missed abortion after failure of medical treatment from June 2016 underwent transvaginal sonography immediately after completion of the procedure as judged by the operator to ensure absence of remnants.

Detailed Description

Women indicated for surgical evacuation of missed abortion up to 12 weeks were included. Standard surgical evacuation of uterus by suction followed by sharp curettage under general anaesthesia were done for all cases. When the operator judged the procedure as complete, transvaginal sonography was done by dedicated sonographer using portable ultrasound machine in theatre. If remnants were detected the procedure was repeated till the cavity seen empty.

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

Name	Type	Description	Arm Group Labels	Other Names
Sonographic examination of uterus after surgical evacuation	Diagnostic Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence remnants of conception	transvaginal sonographic detection	immediately after the end of the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

multiparous. have missed abortion up to 12 weeks gestational age by dating. failed medical evacuation. consented for the procedure.

Exclusion Criteria:

suspicion of sepsis. Suspected molar pregnancy. previous evacuation trial. abnormal uterus like fibroids.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

multiparous women, aged 18 to 45 years with missed abortion up to 12 weeks gestational age, with normal uterus and without suspicion of sepsis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mervat S Omran, M.D	Contact	+2034226106		Mervat.Elsedeek@alexmed.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shatby maternity university hospital	Recruiting	Alexandria		03312	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000022	Abortion, Spontaneous

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided