Use of vaginal creatinine levels in detecting premature rupture of membranes

Abstract

Aim: Misdiagnosis is frequent in premature rupture of membranes (PROM) patients. The most accurate diagnosis of PROM requires reliable laboratory tests. Due to the lack of a gold-standard diagnostic method, many methods have been proposed in this regard. The aim of this study is to determine an easy diagnostic method in early membrane rupture and to determine the usability, reliability and cut-off values of vaginal creatinine measurements in the detection of PROM compared to vaginal placental alpha microglobulin-1 (PAMG-1) test.

Methods: We designed a cross-sectional study. A total of 63 patients admitted to the Obstetrics and Gynecology Clinic of Samsun Ondokuz Mayıs University with suspected PROM between 15 November 2012 and 15 June 2013 were included in this study. Following anamnesis, all patients were vaginally subjected to PAMG-1 (AmniSure® ROM) test with sterile speculum and injected with 5 cc of saline into the vagina, and then, a 3 cc sample was retrieved with the same injector and put into a biochemistry tube. Immediately thereafter, the material was sent to the biochemistry laboratory, centrifuged and stored at -70 0C until all samples were studied. The patients were classified as PROM and non-PROM based on the positive or negative result of PAMG-1 test. Following this classification, the patients were also grouped as PROM and non-PROM according to their vaginal creatinine values.

Results: The mean maternal age of our patients was 26.3 years in the PROM group and 28.8 years in the non-PROM group. The mean gestational weeks were 30.8 weeks in the PROM patients and 32.5 weeks in the non-PROM patients. Of 20 patients subjected to PAMG-1 test for PROM diagnosis, 17 were PAMG-1 and creatinine positive while 3 were PAMG-1 negative and creatinine positive. Of 43 patients subjected to PAMG-1 test, 42 were PAMG-1 negative while 1 was PAMG-1 positive and creatinine negative. Accordingly, vaginal creatinine was found to have 94.4% sensitivity, 93.3% specificity, 85% positive predictive value, and 97.7% negative predictive value in PROM diagnosis. The mean creatinine values in the PROM and non-PROM groups were 0.39 (0.31) mg/dl and 0.04 (0.10) mg/dl, respectively (p=0.05).

Conclusion: Creatinine assessment in vaginal flushing fluid can be a cheaper, faster, easily accessible and highly accurate test with 94.4% sensitivity and 93.3% specificity in PROM diagnosis.

Keywords

• Creatinine,placental alpha microglobulin-1,Premature rupture of membranes

Erken memran rüptürü tespitinde vajinal kreatinin seviyelerinin kullanılması

Öz

Amaç: Erken membran rüptürü (EMR) bulunan hastaların teşhisinde yanılgılar sık görülebilmektedir. EMR tanısını en doğru şekilde koymak için güvenilir laboratuvar testleri gerekir. Altın standart bir tanı metodunun olmaması yüzünden bu konuda birçok yöntemler öne sürülmüştür Bu çalışmada EMR teşhisinde vajinal kreatinin ölçümlerinin %100 yakın güvenirlikle kullanılan vajinal Plasental Alfa mikroglobulin-1 (PAMG-1) testine göre kullanılabilirliği, güvenirliği ve cut off değerlerinin tespiti hedeflenmiştir

Yöntemler: Bu çalışmaya, Samsun Ondokuz Mayıs Üniversitesi Kadın Hastalıkları ve Doğum Kliniği’ne 15 Kasım 2012 – 15 Haziran 2013 tarihleri arasında başvuran toplam 63 EMR şüpheli hasta dahil edilmiştir. Tüm hastalara anamnezi takiben steril spekulum ile vajinal olarak PAMG-1 (AmniSure ® ROM) testi ve ardından vajene 5 cc serum fizyolojik enjekte edilip sonrasında 3 cc aynı enjektörle geri alınarak biyokimya tüpüne koyulmuştur. Hemen ardından materyal biyokimya laboratuvarına gönderilip santrifüj edildikten sonra dondurucuda -70 0C derecede tüm numuneler çalışılıncaya kadar saklanmıştır. Hastalar Plasental Alpha Mikroglobulin-1 (PAMG-1) testinin pozitif ve negatif olup olmamasına göre EMR olan ve EMR olamayan olarak sınıflandırıldı. Bu sınıflamanın ardından vajinal kreatinin değerine göre de hastalar EMR ve EMR olmayan olarak gruplandırıldı.

Bulgular: Olgularımızın ortalama maternal yaş değeri EMR olan hasta gurubunda 26,3 yaş, EMR olmayan gurupta 28,8 yaş idi. EMR olan hastalarda gebelik haftası ortalama değeri 30,8 hafta, EMR olmayan hastalarda ise 32,5 hafta idi. EMR tanısı amaçlı PAMG -1 testi uygulanan 20 hastanın 17 sinde PAMG-1 ve kreatinin pozitif, PAMG-1 negatif olan 3 hastada kreatinin pozitifti. PAMG-1 testi uygulanan 43 hastanın 42 sinde PAMG-1 negatif, 1 inde PAMG-1 pozitif ve kreatinin negatifti. Bu sonuçlara göre vajinal kreatinin EMR teşhisinde %94,4 sensitivite, %93,3 spesifisite, %85 pozitif prediktif değer, %97,7 negatif prediktif değer olarak hesaplandı. EMR olan ve olmayan gurupta ortalama kreatinin değerleri sırasıyla 0,39 (0,31)mg/dl ve 0,04 (0,10) mg/dl (p=0,05).

Sonuç: Vajinal yıkama sıvısında kreatinin ölçümü EMR tanısında daha ucuz, hızlı, kolay ulaşılabilir ve %94,4 sensitivite, %93,3 spesifisite ile yüksek doğruluk oranına sahip bir test olabilir.

Anahtar Kelimeler

• Kreatinin,Erken membran rüptürü,Plasental alfa mikroglobulin

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