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

NCT02904070 | Unknown Phase 4

• 1 other identifier: 2013/CHU/07
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Threat of

Outcome Measures

Primary Outcomes (1)

• Efficient predictivity for premature delivery assessed by Placental Alpha-microglobulin-1 detection test compared with the cervical length

  Occurrence of premature delivery within 7 days of diagnosis depending on the positive / negative status for the Placental Alpha-microglobulin-1 detection test versus cervical length

  Childbirth

Study Arms (1)

Threat of premature delivery

EXPERIMENTAL

* 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

Device: Vaginal swabbing

Interventions

Vaginal swabbing DEVICE

Threat of premature delivery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU de La Réunion - site Nord

Saint-Denis, Reunion Island, 97400, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vanessa BENASSI, MD

  CHU de La Réunion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samir MEDJANE, PhD

CONTACT

+262 (0)262906286; samir.medjane@chu-reunion.fr

Valérie Fontaine

CONTACT

+262 (0)262906283; drci@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 16, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)