Development of a Screening Tool By Utilising Cervical Length Measurement In Relation To Body Mass Index (BMI) For Early Identification And Intervention Of Preterm Birth
Towards Development of an Individualised Screening Tool By Utilising Cervical Length Measurement In Relation To Body Mass Index (BMI) For Early Identification And Intervention Of Preterm Birth
1 other identifier
observational
145
1 country
2
Brief Summary
This is a prospective study where pregnant women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM will be recruited. BMI will be taken both during booking of pregnancy and at recruitment. Cervical length will be measured via transvaginal scan at recruitment time. We aim to assess the association between body mass index, cervical length and risk of preterm birth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
2 active sites
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
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedNovember 3, 2023
November 1, 2023
1.7 years
June 8, 2021
November 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
1. To examine the relationship between body mass index (BMI) and cervical length (CL)
Association of BMI and CL
till February 2023
2. To identify cut-off value of cervical length
Value leading to high risk of spontaneous preterm birth among Malaysian women
till February 2023
3. To assess the association between different cervical length and preterm birth
Association of CL and PTB
till February 2023
4. To examine the association between body mass index and preterm birth
Association of BMI and PTB
till February 2023
5. To develop an individualised screening tool for assessing risk of preterm birth
Attributable risk of preterm birth with relation to BMI and CL
Till May 2023
Eligibility Criteria
Antenatal women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM
You may qualify if:
- Singleton pregnancy between 16-24 weeks gestation
- No history of previous spontaneous preterm birth (gestation between 24-36+6 weeks)
- Agreement to follow up and consented for the study
You may not qualify if:
- Major fetal anomaly
- Multiple pregnancy
- Uterine anatomic malformation
- Those require iatrogenic preterm delivery due to various condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Pengajar UPM
Serdang, Selangor, 43400, Malaysia
Hospital Serdang
Serdang, Selangor, 43400, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator (Dr)
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 10, 2021
Study Start
June 1, 2021
Primary Completion
February 28, 2023
Study Completion
October 31, 2023
Last Updated
November 3, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share