Clinical Trial: Core-temperature Monitoring in Patients With PPROM

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.


Detailed Summary:

Introduction A prelabor rupture of membranes (PROM) is defined as a loss of amniotic fluid within a rupture of amniotic membrane before the onset of labour, as preterm prelabor rupture of membranes (PPROM) refers to PROM before 37+0 weeks of gestation.

PPROM occurs in 3 percent of pregnancies and is associated with one third of preterm births. There are multiple risk-factors for PPROM as maternal physiologic, genetic, and environmental as well as life-style factors. Of note, history of PPROM in a previous pregnancy, antepartum bleeding, cigarette smoking and genital tract infections, as the single most identifiable risk factor, are strongly associated with PPROM.

PPROM is diagnosed by the clinical loss of fluid from the cervical os. In case of not immediately visible amniotic fluid loss during the gynecological inspection, it can be diagnosed by ultrasound and verified by tests like the Amnisure© or the Fertisave© which detect the alpha microgloubulin 1 or the IGF binding protein of the fetal membranes.

Referring to a randomized controlled trial, the majority of pregnancies with PPROM deliver within one week of membrane rupture.

PPROM-related morbidity and mortality, which depends on gestational age, is higher in the neonate than in the mother, especially in case of intrauterine inflammation. Pulmonary hypoplasia, facial and orthopedic deformation can be the cause of prolonged, early PPROMS.

As the incidence of infection is higher at earlier gestational ages, up to one third of women with PPROM develop serious infections, including chorioamnionitis, endometritis and septicemia. Responsible bacterias are enterococcus, staphylococcus or anaerobic species.

Sponsor: Medical University of Vienna

Current Primary Outcome: Body-core-temperature [ Time Frame: 288 times a day from PPROM-verification until delivery ]

The OvulaRing® is a non-invasive thermometer measuring the intravaginal temperature every 5 minutes. This plastic ring including a high-tech-sensor thermometer should be placed into the vaginal fornix for a maximum of 30 days, measuring the intravaginal core-temperature 288 times a day.

As there is no change of common PPROM-therapy, only clinical standard parameters will lead to the termination of pregnancy. Directly before delivery the OvulaRing® will be removed and the sensor-data will be analyzed with a special software.



Original Primary Outcome: Body-core-temperature [ Time Frame: 288 times a day from PPROM-verification until delivery ]

The OvulaRing® is a non-invasive thermometer measuring the intravaginal temperature every 5 minutes. This plastic ring including a high-tech-sensored thermometer should be placed into the vaginal fornix for a maximum of 30 days, measuring the intravaginal core-temperature 288 times a day.

As there is no change of common PPROM-therapy, only clinical standard parameters will lead to the termination of pregnancy. Directly before delivery the OvulaRing® will be removed and the sensor-data will be analyzed with a special software.



Current Secondary Outcome:

  • CRP [ Time Frame: once a day from hospitalization due to PPROM until delivery ]
  • Interleukine (IL-) 6 [ Time Frame: once a day from hospitalization due to PPROM until delivery ]
  • white blood cell count [ Time Frame: once a day from hospitalization due to PPROM until delivery ]


Original Secondary Outcome:

  • CRP [ Time Frame: once a day from hospitalization due to PPROM until delivery ]
  • Interleucine (IL-) 6 [ Time Frame: once a day from hospitalization due to PPROM until delivery ]
  • white blood cell count [ Time Frame: once a day from hospitalization due to PPROM until delivery ]


Information By: Medical University of Vienna

Dates:
Date Received: April 23, 2014
Date Started: January 2017
Date Completion: January 2018
Last Updated: November 28, 2016
Last Verified: November 2016