Monitoring of the Inflammatory Response of Patients With Premature Rupture of Membranes With Bedside Tests (EFFARM)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jean-Charles Pasquier, MD, PhD, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00940043
First received: July 14, 2009
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Prematurity represents 8% of birth and it is one of the leading causes of infant complications. The preterm premature rupture of membranes (PPROM) represents one-third of preterm birth and the rupture of membranes increase the risk of fetal exposition to infection which could lead to neurological sequels. Classic management of women with PPROM before 32SA is based on the extension of the pregnancy with the risk of adding complications like a secondary infection. Moreover, different studies have shown that fetal infection could be one of the most important risk factor for subsequent neurological complications. However, it is difficult to know if it is better to extend the pregnancy to gain in maturity or to arrest the pregnancy to avoid the risk of intrauterine infection. The research objective is to suggest a new strategy to manage women with PPROM. With this new strategy, the investigators seek to extend pregnancy as much as possible but the investigators would like to give birth before the intrauterine infection. The investigators suggest detecting protein associate with neurological complications of preterm child in the amniotic liquid found in the vagina of the mother. A positive test will lead to the delivery of the newborn before its infection. The hypothesis is that it is possible to study changes in the inflammatory status of patients who presented an PPROM from repeated detection of interleukins in vaginal secretions.


Condition
Premature Rupture of Fetal Membranes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Women With Preterm Premature Rupture of Membranes (PPROM) Between 28 and 33 Weeks of Gestation With Repetitive Immunochromatographic Bedside Test to Detect Inflammatory Protein in Vaginal Secretions.

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • comparison between the results of the bedside test and the ELISA tests performed in the laboratory [ Time Frame: after rupture of membranes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • description of the inflammatory status following a rupture of membranes at term and during labor [ Time Frame: after rupture of membranes ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

vaginal secretions


Enrollment: 60
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rupture of fetal membranes
women with rupture of fetal membranes before onset of labor

Detailed Description:

Preterm premature rupture of the membranes (PPROM) represents one-third of preterm births and is the leading cause of perinatal mortality and morbidity. During the latency period, several events such as the ascent of pathogenic microorganisms from the lower genital area could create complications which may culminate in cerebral palsy. Avoiding intrauterine infection appears as one of the most important objective in the PPROM management. Most authors propose the conservative management of women with PPROM, associating antibiotic therapy to corticosteroid administration in patients with PPROM before 30 to 32 weeks. The main benefit of conservative management is prolonging pregnancy, but the benefit must be balanced with the risks of fetal complications. In an effort to diminish the risks of infection linked to a longer latency period, several authors have proposed intentional delivery after PPROM.

The primary objective is the comparison between the results of IMMUNOCHROMATOGRAPHY tests done at the bedside of the patient and the ELISA tests performed in the laboratory.

The secondary outcome is the description of the inflammatory status following a rupture of membranes at term and during labor.

Vaginal secretions samplings are perform after premature rupture of membranes and during labor. The bedside test is performing immediately after sampling and the rest of the sampling is frozen. ELISA assays will be performed on these samples.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women hospitalized for premature rupture of membranes at the CHUS

Criteria

Inclusion Criteria:

  • Women with a single fetus and hospitalized for a rupture of membranes at term or before term.

The criteria for diagnosis of rupture of membranes is based on clinical and biochemical tests, including Fern test and Actim PROM test

Exclusion Criteria:

  • Twin pregnancies, patients in labor, the presence of medical complications which exclude expectant management including abruptio placentae, preeclampsia or eclampsia and fetal death.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940043

Locations
Canada, Quebec
Centre hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jean-Charles Pasquier, MD, PhD Centre hospitalier de l'Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Charles Pasquier, MD, PhD, DR, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00940043     History of Changes
Other Study ID Numbers: 08-072
Study First Received: July 14, 2009
Last Updated: January 15, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Université de Sherbrooke:
bedside test
interleukins
inflammation
vaginal secretions

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on August 01, 2014