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

November 2, 2023 updated by: Nurul Iftida Binti Basri, Universiti Putra Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

General Objective To assess the association between body mass index, cervical length and risk of preterm birth.

Specific Objectives

  1. To examine the relationship between body mass index and cervical length
  2. To identify cut-off value of cervical length leading to high risk of spontaneous preterm birth among Malaysian women
  3. To assess the association between different cervical length and preterm birth
  4. To examine the association between body mass index and preterm birth
  5. To develop an individualised screening tool for assessing risk of preterm birth

Study Type

Observational

Enrollment (Actual)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor Darul Ehsan
      • Serdang, Selangor Darul Ehsan, Malaysia, 43400
        • Hospital Pengajar UPM
      • Serdang, Selangor Darul Ehsan, Malaysia, 43400
        • Hospital Serdang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Singleton pregnancy between 16-24 weeks gestation
  2. No history of previous spontaneous preterm birth (gestation between 24-36+6 weeks)
  3. Agreement to follow up and consented for the study

Exclusion Criteria:

  1. Major fetal anomaly
  2. Multiple pregnancy
  3. Uterine anatomic malformation
  4. Those require iatrogenic preterm delivery due to various condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. To examine the relationship between body mass index (BMI) and cervical length (CL)
Time Frame: till February 2023
Association of BMI and CL
till February 2023
2. To identify cut-off value of cervical length
Time Frame: till February 2023
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
Time Frame: till February 2023
Association of CL and PTB
till February 2023
4. To examine the association between body mass index and preterm birth
Time Frame: till February 2023
Association of BMI and PTB
till February 2023
5. To develop an individualised screening tool for assessing risk of preterm birth
Time Frame: Till May 2023
Attributable risk of preterm birth with relation to BMI and CL
Till May 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GM-IPM/2021/9695300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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