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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04922671

Enrollment

145

Registered

2021-06-10

Start date

2021-06-01

Completion date

2023-10-31

Last updated

2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Length, Preterm Birth

Keywords

body mass index, preterm labour, preterm birth, cervical length

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Malaysia

Outcome results