Value of CA125 and Yolk Sac Morphology in Prediction of P... | NCT03320213

Studies
Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage

NCT03320213

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Oct 25, 2017Actual

Enrollment

192Actual

Phase

Not provided

Conditions

Threatened Miscarriage in First Trimester

Interventions

Not provided

Countries

Not provided

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

Oct 2017

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

Oct 1, 2016Actual

Primary Completion Date

Jul 30, 2017Actual

Completion Date

Jul 30, 2017Actual

First Submitted Date

Oct 8, 2017

First Submission Date that Met QC Criteria

Oct 20, 2017

First Posted Date

Oct 25, 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

Oct 20, 2017

Last Update Posted Date

Oct 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fatma Ahmed Mahmoud Sami, gynecology and obstetrics resident at ministry of health and population, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 serum CA125 level and yolk sac morphology in women with threatened miscarriage is very important to predict pregnancy outcome

Detailed Description

Not provided

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

192Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of serum CA125	Measuring serum level of CA125 by ELIZA kits.	6 - 10 weeks
Evaluation of yolk sac morphology	Evaluating yolk sac size and shape by transvaginal ultrasound	6 - 10 weeks

Secondary Outcomes

Measure	Description	Time Frame
follow up of participants	measuring fetal heart rate by transvaginal ultrasound.	up to 20 weeks
follow up of participants	measuring crown rump length by transvaginal ultrasound.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women between 20-40 years. Pregnancy between 6-10 weeks. single intrauterine spontaneous pregnancy. vaginal bleeding or bloody vaginal discharge with or without pelvic pain for patients with threatened miscarriage.

Exclusion Criteria:

medical disorders with pregnancy. History of recurrent miscarriage. Any maternal disease that would cause an increase in CA125 level. Local gynecological disorders e.g. fibroid. Presence of any uterine malformation. History of congenital abnormalities in previous pregnancy Presence of multiple pregnancy. Presence of anembryonic sac. Absent fetal heart pulsation.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant women at age of 20- 40 years Pregnancy at 6-10 weeks women with single intrauterine spontaneous pregnancy

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000033	Abortion, Threatened

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided