High Versus Low Dose of Magnesium Sulfate as Initial Tocolytic Agent for Preterm Labour in Symptomatic Placenta Previa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Evaluate efficacy (postponing delivery for 48h - till administration of dexamethasone ) of different regimens 0f MgSO4 in patients with pp in preterm . 2) Different regimens of MGSO4 and changes in cervical length
研究概览
简要总结
To assess the efficacy and safety of alternative magnesium sulfate regimens when used as single agent tocolytic therapy for prevention of preterm labour in patients with symptomatic placenta previa and subsequent changes in the cervical length .
详细描述
Placenta previa is implantation of placenta on or near internal os .It is classified into major degree when lower edge of placenta lies within 2 cm from internal os , and minor degree if lower edge of placenta at lower uterine segment but more than 2 cm from internal os .
There are many risk factors for developing placenta previa including multi parity , multiple pregnancy , increased maternal age (>35y ) , previous uterine surgery , history of placenta previa (4-8%) .
A significant degree of uterine contractility has been observed with symptomatic placenta previa. It is directly associated with vaginal bleeding. However, a large percentage of women who have placenta previa associated with haemorrhage will experience subclinical uterine contractions before the onset of overt vaginal bleeding. Therefore, the use of tocolytic agents in management of placenta previa seems reasonable .
Magnesium sulfate alters calcium up take, binding and distribution in smooth muscles of the uterus, so reduces the frequency of cell depolarization and inhibits myometrial contraction .
In addition to its tocolytic action magnesium sulfate also provide neuroprotection to preterm infant . .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy.
- •Gestational age between 28 weeks to 37 weeks.
- •Patients presented to the hospital with per vaginal bleeding and in whom a clinical diagnosis of placenta previa is confirmed by trans vaginal ultrasound.
- •Placenta previa with preterm uterine contractions (< 3 contractions in 10 minutes)
- •Ability to provide informed consent.
排除标准
- •Placental abruption .
- •Women with placenta previa and severe attack of bleeding need immediate termination
- •Clinical criteria of intra uterine infection.
- •intrauterine growth restriction .
- •Fetal anomalies.
- •Fetal distress.
- •intrauterine fetal death.
- •Preterm rupture of membrane
- •High order multiple pregnancies.
- •Treatment with any tocolytic agent before maternal transport.
- •Inability or refusal to provide informed consent.
- •Women with any contraindication for use of magnesium sulfate as patients with renal failure.
- •Patients with bleeding disorder or on anticoagulant therapy .
研究组 & 干预措施
Low dose of magnesium sulfate group
patients will receive 4 g intravenous loading dose of magnesium sulfate on 150 ml saline over 20 minute period. Patients then will receive maintenance therapy with magnesium sulfate 1g / h
干预措施: Magnesium sulfate (Drug)
High dose of magnesium sulfate group
patients will receive 4 g intravenous loading dose of magnesium sulfate on 150 ml saline over 20 minute period. Patients then will receive maintenance therapy with magnesium sulfate 2g/h
干预措施: Magnesium sulfate (Drug)
结局指标
主要结局
Evaluate efficacy (postponing delivery for 48h - till administration of dexamethasone ) of different regimens 0f MgSO4 in patients with pp in preterm . 2) Different regimens of MGSO4 and changes in cervical length
时间窗: 48 hour
comparing efficacy of low vs high dose of MgSO4 to postpone preterm delivery in patients with symptomatic pp and subsequent changes in cervical length
次要结局
- birth weight(at time of delivery)
- Gestational age at delivery(at time of delivery)
- number of full term babies(at time of delivery)
- fetal and Neonatal death .(at time of delivery)
- Neonatal intensive care unit admission & duration of admission(at time of delivery)
- Apgar score at five minutes .(5 minutes)
研究者
Doaa M. Mostafa
Resident of obstetrics &Gynecology
Assiut University