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

Completed

• Conditions: Cervical Length; Preterm Birth

• Registration Number: NCT04922671
• Lead Sponsor: Universiti Putra Malaysia

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

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-10
• Primary Completion: 2023-02-28
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To examine the relationship between body mass index (BMI) and cervical length (CL)	till February 2023	Association of BMI and CL
4. To examine the association between body mass index and preterm birth	till February 2023	Association of BMI and PTB
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
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

Trial Locations

Locations (2)

Hospital Pengajar UPM; 🇲🇾 Serdang, Selangor Darul Ehsan, Malaysia

Hospital Serdang; 🇲🇾 Serdang, Selangor Darul Ehsan, Malaysia