Antenatal Azithromycin to Prevent Preterm Birth in Pregnant Women With Vaginal Cerclage. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gestational age at time of delivery
研究概览
简要总结
In women with indicated vaginal cerclage, this study aims to assess the efficacy of antenatal prophylactic Azithromycin in preventing preterm labor.
详细描述
Study procedures and interventions:
- After approval of study protocol, pregnant women who underwent vaginal cerclage at Ain Shams University Maternity Hospital will be enrolled into the study according to inclusion and exclusion criteria.
- Eligible patients will be randomized using a computer-generated sequence 1:1 either to the Azithromycin group or to non-Azithromycin group.
Randomization: Will be done using computer generated randomization sheet using MedCalc© version 13.
Allocation and Concealment: Will be done by use of sealed opaque envelopes that will be given to a third party (nurse) who will assign the women to study arms. Each woman will be invited to pull out an envelope. According to the number inside her envelope, women will be allocated to either group 1 or group 2 according to a computer- generated random list.
- Intervention:
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age (14-34 weeks).
- •Pregnant women who underwent vaginal cerclage (either history- based or ultrasound based vaginal cerclage)
- •History based cerclage:
- •History of one or more second-trimester pregnancy losses related to painless cervical dilatation and in absence of labor or abruptio placentae; OR
- •Prior cerclage due to painless cervical dilation in the second trimester
- •Ultrasound based cerclage:
- •Current singleton pregnancy, prior spontaneous preterm birth at less than 34 weeks of gestation, and short cervical length (less than 25 mm) before 24 weeks of gestation
排除标准
- •Multiple pregnancy.
- •Current or past history of medical diseases (Diabetes Milletus, Hypertension, Systemic Lupus Erythematosus, Cardiac diseases, etc ).
- •Adverse perinatal outcome due to abdominal trauma.
- •Structural fetal anomalies detected during anomaly scan.
- •Allergy to Azithromycin
研究组 & 干预措施
Azithromycin group
women will receive 500mg Azithromycin (Zithrokan®, Hikma, Egypt) one tablet orally twice daily for three days in 3 courses at 14 weeks, 24 weeks and 32 weeks in addition to routine usual antenatal care.
干预措施: Azithromycin Tablets (Drug)
结局指标
主要结局
Gestational age at time of delivery
时间窗: At time of delivery
the gestational age measured in weeks
次要结局
- Maternal complications(At time of delivery and in the first postpartum week)
- Birth weight(At time of delivery)
- Neonatal complications(At time of delivery and in the first postpartum week)
研究者
Rania Hassan Mostafa
Lecturer
Ain Shams Maternity Hospital