NCT03813849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

3.6 years

First QC Date

April 9, 2018

Last Update Submit

October 25, 2019

Conditions

Miscarriage

Keywords

remnants of conception

Outcome Measures

Primary Outcomes (1)

  • presence remnants of conception

    transvaginal sonographic detection

    immediately after the end of the procedure

Interventions

Sonographic examination of uterus after surgical evacuationDIAGNOSTIC_TEST

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shatby maternity university hospital

Alexandria, 03312, Egypt

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Mervat S Omran, M.D

CONTACT

+2034226106Mervat.Elsedeek@alexmed.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of obstetrics and gynecology

Study Record Dates

First Submitted

April 9, 2018

First Posted

January 23, 2019

Study Start

June 10, 2016

Primary Completion

January 30, 2020

Study Completion

March 30, 2020

Last Updated

October 28, 2019

Record last verified: 2019-10

Locations

EG(1)