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NCT01891370 Clinical Trial

Median Study for Biochemical Serum Markers in First Trimester of Pregnancy

Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01891370
Other study ID # 11060
Secondary ID
Status Completed
Phase N/A
First received June 28, 2013
Last updated September 25, 2015
Start date July 2013
Est. completion date September 2015

Study information
Verified date September 2015
Source PerkinElmer, Wallac Oy
Contact n/a
Is FDA regulated No
Health authority Malaysia: Ministry of HealthPhilippines: Manilla Central University Institutional Review BoardThailand: Khon Kaen University Ethics Committee for Human Research
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Malaysia Hospital Tuanku Jaafar Seremban
Philippines MCU-FDT Medical Foundation Caloocan City
Thailand Khon Kaen University Khon Kaen

Sponsors (1)
Lead Sponsor Collaborator
PerkinElmer, Wallac Oy

Countries where clinical trial is conducted

Malaysia,  Philippines,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary levels of biochemical serum markers 10-13 wks gestation No
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