Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Core-temperature Monitoring in Patients With PPROM for Early Detection of Chorioamnionitis - a Pilot Study
Brief Summary:
The most common reason for preterm prelabor rupture of membrane (PPROM) is an ascendance of infection. Moreover PPROM is one of the main risk factors for chorioamnionitis.
PPROM-related morbidity and mortality is higher in the neonate than in the mother, especially in case of intrauterine inflammation. Of note, the most common biomarkers like CRP and leucocytes are not specific for uterine infections and have not been proven useful in these particular cases. Studies in intensive care medicine could show that there is a possible correlation between onset of infection and body-core-temperature.
The OvulaRing® is a non-invasive thermometer measuring the intravaginal temperature every 5 minutes. It was originally invented to assess the moment of ovulation and optimize fertility.
Twenty patients with verified PPROM between gestation week 22 and 27 should be included in this study. After gynecological and physical examination within verification of PPROM women will be informed and invited to participate in this study. Subsequently informed consent will be obtained and the OvulaRing® placed into the vaginal fornix.
The investigators aim to describe a possible correlation between core-temperature and common biomarkers in clinical use for the detection of chorioamnionitis in patients with PPROM to possibly assess the optimal time for delivery subsequently.