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

Preterm Birth Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922671
• Other study ID #: GM-IPM/2021/9695300
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Length
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
Malaysia	Hospital Pengajar UPM	Serdang	Selangor Darul Ehsan
Malaysia	Hospital Serdang	Serdang	Selangor Darul Ehsan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To examine the relationship between body mass index (BMI) and cervical length (CL)	Association of BMI and CL	till February 2023
Primary	2. To identify cut-off value of cervical length	Value leading to high risk of spontaneous preterm birth among Malaysian women	till February 2023
Primary	3. To assess the association between different cervical length and preterm birth	Association of CL and PTB	till February 2023
Primary	4. To examine the association between body mass index and preterm birth	Association of BMI and PTB	till February 2023
Primary	5. To develop an individualised screening tool for assessing risk of preterm birth	Attributable risk of preterm birth with relation to BMI and CL	Till May 2023