Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02125708 |
| Other study ID # |
0012014 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2017 |
| Est. completion date |
January 2018 |
Study information
| Verified date |
November 2016 |
| Source |
Medical University of Vienna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
The goal of antibiotic prophylaxis/therapy in PPROM is to reduce maternal and neonatal
morbidity and mortality. Women should be observed for signs of infection, including maternal
temperature, fetal heart rate, uterine contractions, and periodically common clinical
infection markers. As the most common biomarkers like CRP and leucocytes are not specific for
uterine infections, they have not been proven useful in these particular cases.
Prematurity is the crucial risk to the fetus with PPROM in the absence of complications like
infection, before 34 weeks of gestation. Therefore, expectative management of uncomplicated
PPROM-pregnancies at this gestational age is routinely used. This includes blood cell and
infection monitoring, avoiding vaginal manipulation, antibiotic prophylaxis/treatment and
corticosteroids.
After having reached gestational week 34+ induction of labour is routinely performed, without
induction of lung maturity. The goal is a quick reaction to a chorioamnionitis with a prompt
delivery.
Materials and Methods This study is conducted as a single centre pilot study in patients with
PPROM. The study was approved by the local ethics committee of the Medical University of
Vienna (IRB number: 1031/2014). Study center is the Department of Obstetrics and Gynecology
of the Medical Universitiy of Vienna General Hospital.
Twenty patients with verified PPROM between gestation week 22 and 27 should be included.
After gynecological and physical examination within verification of PPROM women will be
informed about the study and invited to participate in this study. Subsequently informed
consent will be obtained and the OvulaRing® placed into the vaginal fornix.
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.
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.
Hypothesis In this pilot study, 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.
A correlation between temperature and CRP, leucocytes and IL-6 should be explored. Later on,
these facts may be used to optimize the standard procedures for a PPROM.
In some studies there is pointed out that there is a need for new parameters for
chorioamnionitis. Maybe temperature monitoring can become such a new biomarker.
