Interest of Placental Alpha-microglobulin-1 Detection Test to Assess Risk of Premature Delivery in Reunion Island (PARTOSURE-OI)
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|ClinicalTrials.gov Identifier: NCT02904070|
Recruitment Status : Unknown
Verified September 2016 by Centre Hospitalier Universitaire de la Réunion.
Recruitment status was: Recruiting
First Posted : September 16, 2016
Last Update Posted : September 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Premature Delivery||Device: Vaginal swabbing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
Experimental: Threat of premature delivery
Device: Vaginal swabbing
- Efficient predictivity for premature delivery assessed by Placental Alpha-microglobulin-1 detection test compared with the cervical length [ Time Frame: Childbirth ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904070
|Contact: Samir MEDJANE, PhD||+262 (0)email@example.com|
|Contact: Valérie Fontaine||+262 (0)firstname.lastname@example.org|
|CHU de La Réunion - site Nord||Recruiting|
|Saint-Denis, Reunion Island, France, 97400|
|Contact: Vanessa Benassi, MD email@example.com|
|Principal Investigator:||Vanessa BENASSI, MD||CHU de La Réunion|