Ultrasound Predictors of Early Pregnancy Failure in Patie... | NCT03178682

Studies
Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss

NCT03178682

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 6, 2018Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Recurrent Pregnancy Loss
Early Pregnancy Failure

Interventions

ultrasound parameters

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jul 1, 2017Actual

Completion Date

Oct 1, 2017Actual

First Submitted Date

May 28, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 7, 2017Actual

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

Mar 3, 2018

Last Update Posted Date

Mar 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Radwa Rasheedy Ali, lecturer of obstetrics and gynecology, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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

Detailed Description

Mean gestational sac diameter (MSD) is determined by measuring the mean of 3 diameters (longitudinal, antero-posterior and transverse) which are measured from inside of the sac excluding the decidual reaction from the measurement. It is normally eccentric in location embedded in endometrium, and has a smooth; round or oval shape.
Yolk sac is measured by placing calipers on the inner limits of the longer diameter. It usually appears at the periphery of the gestational sac and should not be floating within the sac. Size of the sac, shape, echogenicity of the rim and center of sac, its number and degenerative changes such as calcification will be evaluated. YS having diameter between 3-7mm, rounded shape, absence of degenerative changes, presence of echogenic rim and hypoechoic center are considered normal. Any deviation from above parameters is considered abnormal.
Crown-rump length (CRL) is the length of the embryo from the top of its head to bottom of torso excluding the yolk sac and the extremities, to be measured in sagittal plane of the embryo and recorded as an average of three measurements.
The MGSD-CRL ratio was calculated as the difference between the MGSD and the CRL if less than 5 mm are prone to first trimester miscarriage.
Embryonic heart rate by M-mode calculated as beat per minute using software of ultrasound machine after measuring by electronic calibers of distance between 2 heart waves on frozen M-mode image.
Uterine artery Doppler with measurement of systolic/diastolic (S/D) ratio, resistance index (RI) and pulsatility index (PI) of uterine arteries.

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

90Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound parameters	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

90 pregnant females with history of recurrent pregnancy loss

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hassan A Bayomy, MD	Professor	Study Director
Amgad E Abou Gamrah, MD	Professor	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university		Cairo		+202	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