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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 14, 2023

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

Clinical Trial Outcome Measures

Primary Measures

  • 1. To examine the relationship between body mass index (BMI) and cervical length (CL)
    • Time Frame: till February 2023
    • Association of BMI and CL
  • 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
  • 3. To assess the association between different cervical length and preterm birth
    • Time Frame: till February 2023
    • Association of CL and PTB
  • 4. To examine the association between body mass index and preterm birth
    • Time Frame: till February 2023
    • Association of BMI and PTB
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universiti Putra Malaysia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nurul Iftida Binti Basri, Dr – Universiti Putra Malaysia
  • Overall Contact(s)
    • Nurul I Binti Basri, 0133452294, nurul.basri@yahoo.co.uk

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