The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Amniotic fluid index
研究概览
简要总结
A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into 2 groups. Group I in which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen plasma in addition to the routine management used in the control group. Group II were treated with routine management including antibiotics and corticosteroids
详细描述
All patients were started on a regimen of hospital bed rest and received antibiotic prophylaxis consisting of ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days . Antenatal corticosteroids were given in the form of dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses.
Fifty to two hundred ml of normal saline was infused to create an adequate pocket in which the infusion needle can be stabilized. After injection of normal saline, alternate infusions of 20 mL of platelets, normal saline (which does not contain Calcium, needed for the clotting process), and 20 mL of (FFP). The infused substances were warmed to a temperature of 37°c. Avoiding contact between the blood products prevents clotting in the lines.
During infusion, the fetal heart rate as well as the accumulation of amniotic fluid was monitored by ultrasound. Usually a total of around 60-80 mL of platelets, 100-150 mL of FFP and 100-150 mL of amnioinfusion fluid was used throughout the procedure
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy pregnant women
- •gestational age of 24 to 34 weeks (calculated by the sure dates of the last menstrual period and confirmed by early 1st trimesteric ultrasound).
- •All women carried a normal healthy singleton fetus
排除标准
- •established preterm labor at admission
- •those with symptoms or signs suggestive of clinical chorioamnionitis.
- •women with uncontrolled medical disorder e.g. severe hypertension, uncontrolled diabetes, chronic renal impairment
- •women with vaginal bleeding regardless its cause.
- •Pregnancies associated with major congenital fetal malformations
- •placental insufficiency or anomalies
- •anterior position of the placenta
- •iatrogenic PPROM
研究组 & 干预措施
Amniopatch group
in which women were subjected to active treatment included prophylactic antibiotics and antenatal corticosteroids with an effort to seal the ruptured membranes using the amniopatch technique.
干预措施: Antibiotics (Drug)
Amniopatch group
in which women were subjected to active treatment included prophylactic antibiotics and antenatal corticosteroids with an effort to seal the ruptured membranes using the amniopatch technique.
干预措施: Corticosteroid (Drug)
Amniopatch group
in which women were subjected to active treatment included prophylactic antibiotics and antenatal corticosteroids with an effort to seal the ruptured membranes using the amniopatch technique.
干预措施: Amniopatch (Procedure)
control group
in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
干预措施: Antibiotics (Drug)
control group
in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Amniotic fluid index
时间窗: one week after the procedure
increase in amniotic fluid index to reach above the 10th percentile for the gestational age
次要结局
未报告次要终点