A Phase 4 interventional study of Vaginal swabbing in Premature Delivery, sponsored by Centre Hospitalier Universitaire de la Réunion. Status unknown at 1 site in France. Open to female participants. Per ClinicalTrials.gov, last updated 2016-09-16.
Sponsored by Centre Hospitalier Universitaire de la Réunion · Phase 4 and Interventional
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.
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's planned enrollment of 300 is above the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 140 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
* 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
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
Time frame: Childbirth
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Mar 2014, a primary completion of Mar 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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