title: [Definite diagnosis of premature rupture of the membranes (PROM) using intra-amniotic dye injection method and development of a new kit (AFP-test kit) for PROM diagnosis].
abstract: In the diagnosis of premature rupture of the membranes (PROM) in the mid-trimester of pregnancy, it is often difficult to obtain reliable information from only an analysis of the amniotic fluid, especially in equivocal cases. In cases where we have not been able to obtain a definite diagnosis of PROM by conventional methods including amnioscopy, we have employed the intra-amniotic dye injection method (PSP method) by abdominal amniocentesis. We have established the method to be good for discrimination of high-leak and low-rupture PROM as well as the rupture of the pseudo-amniotic cavity, and have preliminarily reported on the clinical usefulness and safety of the PSP method since 1981. In this study, through examination of 64 equivocal PROM cases, we have investigated the clinical efficacy of the PSP method for cases in their 14th to 33rd week of gestation. The conventional methods showed a correct diagnostic rate of 63.9%-70.5%, in contrast the PSP method had a 100% rate. We have reconfirmed the clinical efficacy of the PSP method. The PSP method has been proven to be a reliable PROM diagnostic method, but employed for a selected doubtful cases. A non-invasive, reliable and rapid method which can be employed in a repeated manner as a bed-side examination, has been needed for many years. Amniotic fluid contains a high concentration of alpha-fetoprotein(AFP), especially in mid-trimester, and undetectable levels are determined in urine, vaginal fluid and seminal fluid. We have developed a new anti-AFP monoclonal antibody kit for PROM diagnosis. In the present study, we investigated the fundamental ability of AFP-test kit and the clinical efficacy of this kit for 71 cases in their 11th to 40th week of gestation with PROM or suspected PROM. The AFP-test kit method showed a correct diagnostic rate of 100%. The reaction time of this kit is approximately 3 minutes. It is a simple and non-invasive test which can be easily carried out repeatedly as a bed-side examination. This study has confirmed the high efficacy of the AFP-test kit as a method of PROM diagnosis.
authors.affiliation: Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Kishida
mesh_terms: D000649:Amniocentesis; D000911:Antibodies, Monoclonal; D005069:Evaluation Studies as Topic; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis*; D006801:Humans; D007267:Injections; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D000509:alpha-Fetoproteins / Q000032:analysis*
chemical_list: D000911:Antibodies, Monoclonal; D011933:Reagent Kits, Diagnostic; D000509:alpha-Fetoproteins