跳至主要内容
临床试验/IRCT2017092317034N5
IRCT2017092317034N5已完成未知

Targeted therapy for threatened preterm labor based on sonographic measurements of the cervical length in women

Vice chancellor for research of Shiraz University of Medical Sciences0 个研究点目标入组 120 人开始时间: 待定最近更新:

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

研究者

发起方
Vice chancellor for research of Shiraz University of Medical Sciences

相似试验