NCT02419300

Brief Summary

Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.

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
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 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

First Submitted

Initial submission to the registry

April 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

April 10, 2015

Last Update Submit

February 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage

    All patients with endometrial mass after spontineous or medical miscarriage will undergo colour Doppler examination within 1 hour of miscarriage

    60 minutes after delivery

Interventions

pelvic ultrasonography and Doppler

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting The Obstetrics department in Ain Shams University Hospital complaining of early second trimesteric abortion

You may qualify if:

  • Pregnancy duration: early mid-trimester from 14 to 20 weeks
  • Endometrial mass upon ultrasound examination after second trimesteric miscarriage

You may not qualify if:

  • Uterine congenital anomaly
  • Patients with signs of sepsis.
  • Negative scan after second trimesteric miscarriage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Ahmed dr Mohamed, M.D

CONTACT

ebtihal dr kotb, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 17, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations