Interest of Placental Alpha-microglobulin-1 Detection Test to Assess Risk of Premature Delivery in Reunion Island

NCT ID: NCT02904070

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-03-31

Brief Summary

Prematurity is the leading cause of mortality and perinatal morbidity. Despite the many preventive measures and use of tocolytic therapy, the incidence of premature births has not decreased in recent decades. In 2010 the preterm birth rate (single child, born alive) was still 5.5% in France and 11% in the population of Reunion. In 50% of cases, premature birth is related to spontaneous premature labor layout without rupture of amniotic membranes, called threat of premature birth.The threat of premature birth, defined by the combination of cervical modifications and regular and painful uterine contractions from 22 weeks of amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in pathological pregnancies services. But all threat of premature delivery situations do not cause premature delivery. In our service, only 30% of patients hospitalized for threat of premature delivery give birth prematurely in accordance with published international data. The diagnosis of threat of premature delivery is difficult and it is still not possible to differentiate a "false labour" of a "real labour".

Currently the diagnosis of threat of premature delivery in routine is based on the combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks specificity.

In absence of prognostic tool for predicting more reliably the risk of premature delivery in situation of threat of premature delivery, the medical cares are maximalist.: hospitalization, conducting paraclinical investigations, prescription of tocolytics treatments and conducting antenatal corticotherapy. it seems particularly necessary to identify more efficient prognostic criteria that the clinic and ultrasound for judging the severity of threat of premature delivery in other words to predict the risk of premature delivery to adapt and adjust the care of patients after diagnosis of threat of premature delivery.

Conditions

Premature Delivery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Threat of premature delivery

• Perform detection test of Placental Alpha-Microglobulin-1, fetal Fibronectin and phosphorylated Insulin-like Growth Factor Binding Protein-1ph by vaginal swabbing;
• Collection of clinical data, laboratory data and treatment of obstetric care in the delivery room during childbirth for all included subjects

Group Type: EXPERIMENTAL

Vaginal swabbing

Intervention Type: DEVICE

Interventions

Vaginal swabbing

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients received in programmed or emergency consultation;
• Pregnant, between 24 weeks of amenorrhea and 33 weeks of amenorrhea + 6 days;
• With painful regular uterine contractions confirmed by monitoring;
• Patient affiliated to a social security scheme;
• Informed consent signed by patient if adult or by legal representant for minor subjects

Exclusion Criteria

• cervical cerclage placement;
• proved vaginal infection and/or vaginal ongoing treatment;

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa BENASSI, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de La Réunion

Locations

CHU de La Réunion - site Nord

Saint-Denis, Reunion Island, France

Site Status: RECRUITING

Countries

France

Central Contacts

Samir MEDJANE, PhD

Role: CONTACT

samir.medjane@chu-reunion.fr

+262 (0)262906286

Valérie Fontaine

Role: CONTACT

drci@chu-reunion.fr

+262 (0)262906283

Facility Contacts

Vanessa Benassi, MD

Role: primary

drci@chu-reunion.fr

Other Identifiers

2013/CHU/07

Identifier Type: -

Identifier Source: org_study_id