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

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.

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Key information

Conditions

Cervical Length Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Pengajar UPM, Serdang, Selangor, Malaysia

About this study

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

Specific Objectives

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Major fetal anomaly
Multiple pregnancy
Uterine anatomic malformation
Those require iatrogenic preterm delivery due to various condition

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jun 10, 2021
Registry last updated: Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed