A Comparison of the Effectiveness in Management of Threatened Preterm Labor Between Cervical Length-based Approach and Conventional Approach: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of cases with delivery within 7 day after admission
研究概览
简要总结
To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant with symptoms of threatened preterm labor which refer to regular uterine contractions at least 1 time in every 10 minutes and persist for 30 minute without cervical dilatation or cervical dilation ≤ 1 cm and < 80% of effacement.
- •Age ≥ 18 years
- •Singleton pregnancy
- •24 0/7 - 33 6/7 weeks of gestation
- •Uneventful antenatal care or low-risk pregnancies
排除标准
- •The definitive diagnosis of true labor
- •Proceed to the active phase of labor
- •Age < 18 years
- •Multiple pregnancies
- •< 24 or ≥ 34 weeks of gestation
- •Fetal chromosomal or structural abnormalities
- •Abnormal fetal growth
- •Abnormal amniotic fluid
- •Evidence of placenta previa
- •Significant vaginal bleeding that cannot be ruled out placenta previa
- •Evidence of rupture of membranes
- •Evidence of intrauterine infection
- •Evidence of uterine malformation
- •Evidence of lethal fetal malformation
- •Unable to communicate or understand the information of the study
研究组 & 干预措施
TVCL-based
Monitor progression of labor by shortening of cervix examined by transvaginal cervical length
干预措施: Transvaginal ultrasound (Procedure)
Conventional-based
Monitor progression of labor by per vaginal exam to detect cervical change
干预措施: Transvaginal ultrasound (Procedure)
结局指标
主要结局
Number of cases with delivery within 7 day after admission
时间窗: From admission to no uterine contraction in 10 minute
In case of threatened preterm labor if detection the progression of labor by transvaginal cervical length, the rate of delivery within 7 days will less or more than conventional group.
次要结局
- The number of tocolysis courses, length of hospital stay(From admission to no uterine contraction in 10 minute)
- The number of steroid courses(From admission to no uterine contraction in 10 minute)
研究者
Kuntharee Traisrisilp
Assistant professor
Chiang Mai University