NCT04859179

Brief Summary

Spinal muscular atrophy (SMA) prenatal carrier screening is recommended by American College of Medical Genetics (ACMG) and American College of Obstetrics and Gynecology (ACOG). However, in Thailand, there are no standard protocol for SMA prenatal carrier screening.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 10, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

March 26, 2021

Last Update Submit

April 21, 2021

Conditions

Spinal Muscular Atrophy

Keywords

spinal muscular atrophyprenatal screening

Outcome Measures

Primary Outcomes (1)

  • Rate of acceptance of prenatal carrier screening for spinal muscular atrophy

    Rate of acceptance of prenatal carrier screening for spinal muscular atrophy among pregnant women seeking prenatal care

    12 months

Secondary Outcomes (4)

  • Factors associated rate of acceptance of prenatal carrier screening for spinal muscular atrophy

    12 months

  • Copies number of SMN1 and SMN2 genes in pregnant women

    12 months

  • Carrier frequency among individuals who accepted carrier screening

    12 months

  • Pregnant women's attitudes toward spinal muscular atrophy and carrier screening

    12 months

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All pregnant women who came to antenatal care clinic at Ramathibodi Hospital, Mahidol University

You may qualify if:

  • Maternal age \> 18 years
  • Singleton pregnancy
  • Gestational age ≤ 14 weeks

You may not qualify if:

  • Refuse to participate the research trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, plasma and DNA

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular Diseases

Study Officials

  • Chayada Tangshewinsirikul

    Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chayada Tangshewinsirikul

CONTACT

0898905444chayada.tan@mahidol.ac.th

Takol Chareonsirisuthigul

CONTACT

021677066takol.cha@mahidol.ac.th

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 26, 2021

Study Start

March 10, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations

TH(1)