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Core-temperature Monitoring in Patients With PPROM

Sponsored by Medical University of Vienna

About this trial

Last updated 5 years ago

Study ID

0012014

Status

Withdrawn

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 60 Years
Female

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* single pregnancy

* verified PPROM

* gestation week 22 to 27

* signed informed consent (ICF)

Exclusion Criteria

* multiple pregnancy

* Patient's age under 18 years

* Allergy to epoxide resin or ethylene vinyl acetate (EVA)-Copolymer