Targeted therapy for threatened preterm labor based on sonographic measurements of the cervical length in women
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
Background: Preterm labor and birth are associated with several neonatal complications including respiratory distress syndrome and intraventricular hemorrhage. Differentiating true and false labor pain is a dilemma to obstetricians. Objective: To elucidate the role of cervical length measurement in prediction of birth in pregnant women with threatened preterm labor. Materials and Methods: In this double blind randomized clinical trial, 120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length. Patients were registered in the hospital and a unit number was given. Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator. All participants were managed accordingly (n=65) or to receive tocolysis as planned (n=55). Tocolysis was prescribed when cervical length was <15 mm while those with cervical length =15 mm were managed expectantly. Delivery within 7 days of the presentation was the primary outcome. Results: This RCT showed in case group, 78.9% of patient with cervical length <15 mm were delivered within 7 days and only 21.1% of them maintained their pregnancy. Of those with cervical length =15 mm, only 15.2% were delivered within the study period and the rest (84.8%) maintained their pregnancy (p<0.001). Conclusion: “Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment. Women with cervical length =15mm should not receive tocolysis, however, withholding corticosteroid therapy in these patients needs further evidence.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 40 years(—)
- 性别
- Female
入选标准
- •At least 4 contractions in 20 min interval
- •Single pregnancy
- •Gestational age before 34 weeks
- •Maternal age 18-40 y
排除标准
- •Polyhydramnios (amniotic fluid index greater than 24 cm)
- •Macrosomia(estimated fetal weight >90th centile)
- •Rupture of membranes
- •Cervical dilatation >5 cm
- •Multiple pregnancy
- •Suspected intrauterine infection
- •Vaginal bleeding (more than bloody show)
- •Major medical disorders in mother
- •Contraindicated for vaginal delivery(e.g. placenta previa)
- •Non-reassuring fetal heart monitoring
- •Fetal anomaly
- •Any contraindication for administer of beta-sympathomimetic drugs and previous treatment with tocolytics/corticosteroid in this pregnancy
