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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02904070
Acronym
PARTOSURE-OI
Enrollment
300
Registered
2016-09-16
Start date
2014-03-31
Completion date
2017-03-31
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Delivery

Keywords

Threat of

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.

Interventions

DEVICEVaginal swabbing

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Efficient predictivity for premature delivery assessed by Placental Alpha-microglobulin-1 detection test compared with the cervical lengthChildbirthOccurrence 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

Countries

France

Contacts

Primary ContactSamir MEDJANE, PhD
samir.medjane@chu-reunion.fr+262 (0)262906286
Backup ContactValérie Fontaine
drci@chu-reunion.fr+262 (0)262906283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026