NCT02125708

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 26, 2021

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

April 23, 2014

Last Update Submit

February 23, 2021

Conditions

Preterm Premature Rupture of Fetal Membranes

Keywords

preterm prelabor rupture of membranesOvula Ringbody-core-temperaturebiomarkersSingle pregnanciesPPROMgestation week 22 and 27

Outcome Measures

Primary Outcomes (1)

  • Body-core-temperature

    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.

    288 times a day from PPROM-verification until delivery

Secondary Outcomes (3)

  • CRP

    once a day from hospitalization due to PPROM until delivery

  • Interleukine (IL-) 6

    once a day from hospitalization due to PPROM until delivery

  • white blood cell count

    once a day from hospitalization due to PPROM until delivery

Study Arms (1)

OvulaRing®

OTHER

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.

Device: OvulaRing®

Interventions

OvulaRing®DEVICE

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-sensor thermometer should be placed into the vaginal fornix for a maximum of 30 days, measuring the intravaginal core-temperature 288 times a day.

OvulaRing®

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • single pregnancy
  • verified PPROM
  • gestation week 22 to 27
  • signed informed consent (ICF)

You may not qualify if:

  • multiple pregnancy
  • Patient's age under 18 years
  • Allergy to epoxide resin or ethylene vinyl acetate (EVA)-Copolymer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Fetal Membranes, Premature RupturePreterm Premature Rupture of the Membranes

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ljubomir Petricevic, Ass. Prof. M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Dr.

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 29, 2014

Study Start

January 1, 2017

Primary Completion

August 1, 2017

Study Completion

January 1, 2018

Last Updated

February 26, 2021

Record last verified: 2016-11

Locations

AU(1)