Clinical trial NCT04922671: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Length
Preterm Birth
Keywords: body mass index
preterm labour
preterm birth
cervical length
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 145
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: 1. To examine the relationship between body mass index (BMI) and cervical length (CL)
timeFrame: till February 2023
measure: 2. To identify cut-off value of cervical length
timeFrame: till February 2023
measure: 3. To assess the association between different cervical length and preterm birth
timeFrame: till February 2023
measure: 4. To examine the association between body mass index and preterm birth
timeFrame: till February 2023
measure: 5. To develop an individualised screening tool for assessing risk of preterm birth
timeFrame: Till May 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Hospital Pengajar UPM
state: Selangor Darul Ehsan
city: Serdang
country: Malaysia
facility: Hospital Serdang
state: Selangor Darul Ehsan
Study officials:
References: