NCT06537778已完成不适用
Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
Children's Hospital of Chongqing Medical University2 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2018年1月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Rate of sPTB
研究概览
简要总结
After ultrasound-indicated cerclage, some pregnant women still experience sPTB, and there is controversy regarding the use of tocolytic agents during the perioperative period to reduce the incidence of sPTB. In this study, the investigators employed a randomized double-blind method to investigate whether the use of atosiban during the perioperative period can reduce the incidence of sPTB before 34 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(i) Viable singleton gestation between 14 0/7 and 23 6/7 weeks of gestation.
- •(ii) Previous history of miscarriage or preterm labor in mid-pregnancy.
- •(iii) Transvaginal ultrasound examination showed that the cervix is 25mm or less at gestations less than 24 weeks.
排除标准
- •(i) Women with uterine contractions.
- •(ii) Vaginal bleeding.
- •(iii) Symptoms of chorioamnionitis.
- •(iv) Medically indicated PTB (severe preeclampsia, placental abruption, preterm premature rupture of membranes).
- •(v) Major structural or chromosomal abnormalities.
- •(vi) Contraindication to atosiban.
- •(vii) Had received atosiban or any tocolytic agents within 7 days before their presentation.
研究组 & 干预措施
atosiban
Experimental
干预措施: Atosiban (Drug)
normal saline
Placebo Comparator
干预措施: Normal saline (Drug)
结局指标
主要结局
Rate of sPTB
时间窗: up to 34 weeks
Rate of sPTB before 34 weeks of gestation
次要结局
- Rate of preterm premature rupture of membranes(through study completion, an average of 1 year)
- Gestational latency after cerclage placement (days)(through study completion, an average of 1 year)
- Rate of preterm delivery <28 or <32 weeks gestation(up to 32 weeks)
- Gestational age at delivery (weeks)(through study completion, an average of 1 year)
研究者
Li Qin
Principal Investigator
Children's Hospital of Chongqing Medical University
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
4 期
Effects of Atosiban on uterine peristalsis following frozen embryo transfer: a randomized controlled trialuterine peristalsis following frozen embryo transferuterine peristalsis,frozen embryo transferTCTR20200608002Faculty of Medicine Khon Kaen University50
已完成
4 期
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean SectionCaesarean SectionPain, AcuteNCT04172727Ataturk University60
已完成
不适用
Ultrasound-guided TAP Block Vs Local Wound Infiltration for Analgesia After Cesarean Section.Postoperative Pain ControlNCT04711096Ain Shams Maternity Hospital300
已完成
不适用
Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean SectionAnalgesiaNCT05136118Ain Shams University308
已完成
不适用
ltrasound and Doppler flow study of placental invasion of myometrium and its maternal and fetal effectsPlacenta accretaReproductive Health and Childbirth - Fetal medicine and complications of pregnancyACTRN12615000309583Ahmed Maged280