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

NCT ID: NCT04922671

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-10-31

Brief Summary

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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

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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

Conditions

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Cervical Length Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Nurul Iftida Binti Basri

Principal Investigator (Dr)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Pengajar UPM

Serdang, Selangor, Malaysia

Site Status

Hospital Serdang

Serdang, Selangor, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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GM-IPM/2021/9695300

Identifier Type: -

Identifier Source: org_study_id

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