View clinical trials related to Amniotic Fluid Leakage.
Filter by:Although much investigation has been done on the use of ferning in the second and third trimesters, particularly with the development of rapid protein clinical assays, there appears to be lower ferning rates in clinical practice with traditional techniques compared to previous published research on the subject. Much of the older study designs are lacking in detail and lack a large enough sample sizes at each gestational age to appropriately interpret the significance of ferning results by gestational age. Additionally, a large premise for the current tests used to diagnose rupture of membranes is based on these older studies. Given this, we propose collecting amniotic fluid vaginally to evaluate for the presence of ferning in the second trimester to determine if there is a difference in ferning based on gestational age as well as the time interval after rupture of membranes in which ferning can observed on microscope examination.
Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 and who finally were diagnosed as PPROM were included in the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission, hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios, and those who declined to involve in the study were excluded. In all included women were examined at the admission for amniotic fluid index via trans abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All included patients were assessed in two groups; women with AFI<5 and those with AFIā„5 cm. Included patients were followed in terms of maternal and fetal complications. Maternal complications were chorioamnionitis, placental abruption, placental retention, postpartum endometritis, postpartum hemorrhage; while fetal complications comprised necessity of admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome, respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10, APGAR score of 5th minute below 5. All complication rates were compared between the groups. In addition, the time period between the diagnosis of PPROM and the time of delivery was defined as latency period and were compared between the groups.
This study is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage or a "water breaking". The AL-SENSE is an extended shelf-life product that is technically simple, fast to react, visually readable, and therefore enables women to test the cause of any unidentified wetness. An additional, secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and specificity that are comparable to those specified for the currently marketed AMNIOTESTTM (nitrazine yellow swabs; PRO LAB Diagnostics) product.
The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.
The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence.