Median Study for Biochemical Serum Markers in First Trime... | NCT01891370

Studies
Median Study for Biochemical Serum Markers in First Trimester of Pregnancy

NCT01891370

Sponsor

PerkinElmer, Wallac Oy

Status

Completed

Last Update Posted

Sep 28, 2015Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Not provided

Countries

Malaysia
Philippines
Thailand

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

Sep 2015

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

Jul 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jun 28, 2013

First Submission Date that Met QC Criteria

Jul 2, 2013

First Posted Date

Jul 3, 2013Estimated

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

Sep 25, 2015

Last Update Posted Date

Sep 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to get initial values (normal medians) for certain biochemical serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood pressure measurement and certain ultrasound measurement may be established.

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

Retention

Enrollment

200Actual

Measure	Description	Time Frame
levels of biochemical serum markers		10-13 wks gestation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written informed consent
maternal age 18 - 45 years
gestational age 10 -13 (+6 days)verified by ultrasound

Exclusion Criteria:

mental retardation or other mental disorders that impose doubts regarding the true subject's willingness to participate in the study
lack of needed demographic data

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

women in first trimester of pregnancy coming to antenatal assessment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Tuanku Jaafar		Seremban			Malaysia
MCU-FDT Medical Foundation