Prediction of spontaneous preterm birth in women by transvaginal sonographic measurement of cervical length between 18 to 24 weeks of gestation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1) Mean cervical length between 18-24 weeks of gestation
研究概览
简要总结
AIM: To measure cervical length between 18-24 weeks of gestation by transvaginal ultrasonography for prediction of spontaneous preterm birth
Primary outcome:
-
Mean cervical length between 18-24 weeks of gestation
-
No. of women who deliver before 34 weeks of gestation
Secondary outcome:
-
No. of women who delivers before 37 weeks of gestation
-
Proportion of women with cervical length less than 25mm who delivers before 34 and 37 weeks of gestation
-
Proportion of women with cervical length more than 25 mm who delivers before 37 and 37 weeks of gestation
Methodology:
100 Pregnant women seeking antenatal care between 18-24 weeks of gestation fulfilling inclusion and exclusion criteria will be recruited for the study. Cervical length measurement by transvaginal ultrasound will be done. All the women will be followed till delivery and the details of gestational age at delivery, mode of onset of labor, obstetrical outcome and neonatal outcome will be recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women within the age group of 18-35 years.
- •Single live intrauterine pregnancy with gestational age 18-24 weeks.
- •Confirmation of gestational age with at least one ultrasound performed at less than 16 weeks.
排除标准
- •Previous history of Preterm Delivery(less than 37 weeks) 2) Previous history of cervical Surgery 3) Any diagnosed uterine structural anomaly 4) Any fetal congenital malformation 5) Placenta previa in present pregnancy.
结局指标
主要结局
1) Mean cervical length between 18-24 weeks of gestation
时间窗: upto 22 weeks
2) No. of women who deliver before 34 weeks of gestation
时间窗: upto 22 weeks
次要结局
- 1) No. of women who deliver before 37 weeks of gestation
研究者
Dr Kanishka Yadav
Maulana Azad medical college
