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

Premature Rupture of Fetal Membranes Clinical Trial

— EFFARM  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940043
• Other study ID #: 08-072
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: January 15, 2013
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2013
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Fetal Membranes
• Rupture

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison between the results of the bedside test and the ELISA tests performed in the laboratory		after rupture of membranes	No
Secondary	description of the inflammatory status following a rupture of membranes at term and during labor		after rupture of membranes	No