NCT00510380

Brief Summary

This study is carried out to discover if a baby with restricted growth in the womb is subject to specific fetal programming which predisposes to the metabolic syndrome(diabetes,hypertension,heart disease) in adulthood.We have elected to first study this condition in Chinese population in Singapore with the eventual plan of studying all ethnic groups. This is important for understanding the molecular basis of adult-onset disease such as diabetes, identifying children at risk of developing this disease in future and targeting specific strategies for intervention and disease prevention. Intrauterine fetal programming is effected through epigenetic changes similar to those previously identified in animal studies. The epigenetic markers can be found in growth restricted Chinese pregnancies in the local population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

First QC Date

August 1, 2007

Last Update Submit

September 18, 2009

Conditions

Study Arms (2)

growth-restricted Chinese pregnancies

appropriately-grown Chinese pregnancies

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Babies from Chinese women with single pregnancies

You may qualify if:

  • Chinese women,
  • Singleton pregnancies,
  • fetal growth restriction diagnosed clinically and by ultrasound parameters,
  • Normally grown fetuses by clinical and ultrasound criteria

You may not qualify if:

  • Non-Chinese women
  • Multiple pregnancies
  • Co-existing antenatal complications including sever pre-eclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yap Seng Chong, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

April 1, 2007

Study Completion

April 1, 2009

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations