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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- 1. To examine the relationship between body mass index (BMI) and cervical length (CL)
研究概览
简要总结
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.
详细描述
General Objective To assess the association between body mass index, cervical length and risk of preterm birth.
Specific Objectives
- To examine the relationship between body mass index and cervical length
- To identify cut-off value of cervical length leading to high risk of spontaneous preterm birth among Malaysian women
- To assess the association between different cervical length and preterm birth
- To examine the association between body mass index and preterm birth
- To develop an individualised screening tool for assessing risk of preterm birth
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy between 16-24 weeks gestation
- •No history of previous spontaneous preterm birth (gestation between 24-36+6 weeks)
- •Agreement to follow up and consented for the study
排除标准
- •Major fetal anomaly
- •Multiple pregnancy
- •Uterine anatomic malformation
- •Those require iatrogenic preterm delivery due to various condition
结局指标
主要结局
1. To examine the relationship between body mass index (BMI) and cervical length (CL)
时间窗: till February 2023
Association of BMI and CL
4. To examine the association between body mass index and preterm birth
时间窗: till February 2023
Association of BMI and PTB
2. To identify cut-off value of cervical length
时间窗: 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
时间窗: till February 2023
Association of CL and PTB
5. To develop an individualised screening tool for assessing risk of preterm birth
时间窗: Till May 2023
Attributable risk of preterm birth with relation to BMI and CL
次要结局
未报告次要终点
研究者
Nurul Iftida Binti Basri
Principal Investigator (Dr)
Universiti Putra Malaysia