Remnants of Conception After Suction Evacuation of Missed Abortion

October 25, 2019 updated by: Mervat Sheikhelarab Elsedeek Ibrahim Omran, University of Alexandria

Sonographic Detection of Remnants After Surgical Evacuation of Missed Abortion

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2016

Primary Completion (Anticipated)

January 30, 2020

Study Completion (Anticipated)

March 30, 2020

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0409/016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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