NCT03178682

Brief Summary

evaluation of the role of ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

May 28, 2017

Last Update Submit

March 3, 2018

Conditions

Recurrent Pregnancy LossEarly Pregnancy Failure

Outcome Measures

Primary Outcomes (1)

  • number of patients develops 1st trimester pregnancy loss

    defined as a non-viable intrauterine pregnancy with either empty gestational sac or gestational sac containing embryo or fetus without fetal heart activity

    within the first 13 weeks of pregnancy.

Interventions

ultrasound parametersDIAGNOSTIC_TEST

ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss.

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

90 pregnant females with history of recurrent pregnancy loss

You may qualify if:

  • A positive pregnancy test result.
  • Single intrauterine pregnancy.
  • Gestational age by last menstrual period of 6-10 weeks in patients with regular cycles and sure of her last menstrual period date.
  • History of recurrent pregnancy loss which is defined as three or more consecutive pregnancy losses.

You may not qualify if:

  • Women who are uncertain of her last menstrual period date.
  • Women with irregular menstrual cycles.
  • Multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, +202, Egypt

Location

Study Officials

  • Hassan A Bayomy, MD

    Professor

    STUDY DIRECTOR

  • Amgad E Abou Gamrah, MD

    Professor

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 7, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

EG(1)