NCT01891370

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

June 28, 2013

Last Update Submit

September 25, 2015

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • levels of biochemical serum markers

    10-13 wks gestation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women in first trimester of pregnancy coming to antenatal assessment

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Tuanku Jaafar

Seremban, Malaysia

Location

MCU-FDT Medical Foundation

Caloocan, Philippines

Location

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 3, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

September 1, 2015

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

TH(1)MY(1)PH(1)