Trans-perineal Ultrasound in Assessment of Preterm Pre-labor Rupture of Membranes Compared to Speculum Examination: Accuracy Study
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
- Accuracy in diagnosis of PPROM by trans-perineal ultrasound
研究概览
简要总结
Accurate and timely diagnosis of preterm pre-labor rupture of membranes (PPROM) is important to prevent adverse maternal and fetal outcomes. Following a history of PPROM, physical examination should be performed in a way that minimizes the risk of infection using a speculum. This is important to confirm the diagnosis by visualizing the amniotic fluid passing from the cervical canal or pooling in the vagina. In addition to examining the cervix to assess its dilatation and effacement and look for umbilical cord prolapse or fetal prolapse. However, Pelvic exam is one of the most common anxiety provoking medical procedures that's why this study aims at using the transperineal ultrasound as a non-invasive, accurate, cost effective, applicable and readily available tool in assessment of PPROM with less patient anxiety and fear.
详细描述
Preterm pre-labor rupture of membranes (PPROM) refers to the disruption of fetal membranes before the beginning of labor, resulting in spontaneous leakage of amniotic fluid. PROM, which occurs prior to 37 weeks of gestation, defined as preterm PROM. The definition is similarly defined by ACOG, NICE, RANZCOG and World Health Organization (WHO).
PROM occurs in approximately 5%-10% of all pregnancies, of which approximately 80% occur at term.
There are numerous risk factors for PPROM, such as intrauterine infection at early gestational age, lower socioeconomic status of pregnant women, inadequate prenatal care and inadequate nutrition during pregnancy, sexually transmitted infections, vaginal bleeding, and smoking during pregnancy.
PPROM is linked to significant maternal and fetal morbidity and mortality. It has been shown to be the cause of 18%-20% and 21.4% of prenatal mortalities and morbidity respectively.
Complications of PPROM for the fetus and newborn consist of prematurity, fetal distress, cord compression, deformation and altered pulmonary development leading to pulmonary hypoplasia and pulmonary hypertension, necrotizing enterocolitis (NEC) and neurologic disorder.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Pregnant women with history suggestive of preterm prelabor rupture of membranes (PPROM):
- •Sudden gush of fluid per vagina or.
- •Continuous leakage of fluid per vagina or.
- •Feeling wet or.
- •Feeling inability to stop urinating.
- •24 to 37 weeks' gestation.
排除标准
- •• Women in active labor (uterine contraction with cervical dilatation more than or equal to 5 cm).
- •Women with vaginal bleeding.
- •Vulvovaginitis (vaginal discharge).
- •Cervical cerclage in place.
- •Intrauterine fetal demise (IUFD).
结局指标
主要结局
Accuracy in diagnosis of PPROM by trans-perineal ultrasound
时间窗: at time of diagnosis (24 to 37 weeks' gestation)
Images by ultrasound will be evaluated for appearance of accumulated hypoechogenic fluid around cervix. Whenever collection is spotted, three largest dimensions of fluid will be measured (length, width, depth) comparing it to speculum examination by observing amniotic fluid leaking through the cervix or pooling of amniotic fluid in posterior vaginal vault
次要结局
- assessment of cervical length and dilatation by ultrasound (objective) in mm.(at time of diagnosis (24 to 37 weeks' gestation))
- assessment of fetal parts or cord prolapse by ultrasound(at time of diagnosis (24 to 37 weeks' gestation))
- assessment of patients' anxiety (Tolerability to the examination)(at time of diagnosis (24 to 37 weeks' gestation))
研究者
Maya Abdelrazek
Lecturer in Obstetrics and Gynecology
Ain Shams University