NCT07696858尚未招募不适用
Prognostic Factors Affecting the Success of Short-Term Tocolysis in Preterm Labor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Successful short-term tocolysis, defined as postponement of delivery for at least 48 hours after initiation of tocolytic therapy
研究概览
简要总结
The aim of this study is to identify independent prognostic factors associated with the success of short-term tocolysis, defined as delivery delayed by at least 48 hours, in women with singleton preterm labor
详细描述
All participants will receive short-term tocolytic therapy according to the unit protocol.
- The choice of tocolytic agent (., Magnesium sulphate ) will be determined by the treating physician.
- Tocolysis will be administered for a maximum duration of 48-72 hours.
- Antenatal corticosteroids (Betamethasone amp 12mg once daily for 2days) will be administered to eligible participants to enhance fetal lung maturity.
- Failure documented when there is efficient uterine contractions more 4/10mins each one lasts more than 40 seconds, and there was progressive cervical dilatation more 3cm
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 45 years old.
- •Singleton Pregnancy
- •Gestational age between 24 and 34 weeks, confirmed by last menstrual period and/or first-trimester ultrasound.
- •Diagnosis of preterm labor, defined as Regular uterine contractions (≥4 in 20 minutes recorded in CTG) with a documented change in cervical dilation (e.g., from<1 cm to ≥2 cm) or, in nulliparous women, a dilation of ≥2 cm
- •Intact membranes at the time of presentation.
排除标准
- •Established preterm labor (efficient uterine contractions 4/10mins each one lasts more than 40 Seconds recorded in CTG, with cervical changes (dilatation>4cm, effacement>80%)).
- •Evidence of chorioamnionitis or intrauterine infection.
- •Preterm premature rupture of membranes (PPROM).
- •Maternal medical disorders contraindicating tocolysis, such as severe preeclampsia, significant cardiac disease, or uncontrolled diabetes mellitus.
- •Contraindications to continuation of pregnancy, including placental abruption or placenta previa with bleeding.
- •Vaginal bleeding of unknown origin" as a specific exclusion criterion, as it may indicate abruption or other pathologies.
结局指标
主要结局
Successful short-term tocolysis, defined as postponement of delivery for at least 48 hours after initiation of tocolytic therapy
时间窗: 48 hours
次要结局
未报告次要终点
研究者
Mohamed Taleb Hussein Abdellattif
Mohamed Hussein Abdelatif Teleb
Sohag University
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