ClinicalTrials.gg
CompletedNCT04922671Updated Nov 3, 2023

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

An observational study in Cervical Length and Preterm Birth, sponsored by Universiti Putra Malaysia. Completed at 2 sites in Malaysia. Open to female participants. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by Universiti Putra Malaysia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
145
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • Cervical Length
  • Preterm Birth

Keywords

  • body mass index
  • preterm labour
  • preterm birth
  • cervical length
03

In context

Premature Birth

2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's enrollment of 145 is above the median of 115 across 798 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Universiti Putra Malaysia is the lead sponsor of 145 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Antenatal 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Major fetal anomaly
  2. Multiple pregnancy
  3. Uterine anatomic malformation
  4. Those require iatrogenic preterm delivery due to various condition
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
145 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 1. To examine the relationship between body mass index (BMI) and cervical length (CL)

    Association of BMI and CL

    Time frame: till February 2023

  2. 2. To identify cut-off value of cervical length

    Value leading to high risk of spontaneous preterm birth among Malaysian women

    Time frame: till February 2023

  3. 3. To assess the association between different cervical length and preterm birth

    Association of CL and PTB

    Time frame: till February 2023

  4. 4. To examine the association between body mass index and preterm birth

    Association of BMI and PTB

    Time frame: till February 2023

  5. 5. To develop an individualised screening tool for assessing risk of preterm birth

    Attributable risk of preterm birth with relation to BMI and CL

    Time frame: Till May 2023

07

Study locations

2 sites
  • Hospital Pengajar UPM
    Serdang, Selangor 43400, Malaysia
  • Hospital Serdang
    Serdang, Selangor 43400, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04922671
Responsible party
Nurul Iftida Binti Basri (Principal Investigator (Dr), Universiti Putra Malaysia) — Principal investigator
First posted
Jun 10, 2021
Start date
Jun 1, 2021
Primary completion
Feb 28, 2023
Completion
Oct 31, 2023
Last update
Nov 3, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion