Premature Delivery Clinical Trial
— PARTOSURE-OI
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | March 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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; |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de La Réunion - site Nord | Saint-Denis | Reunion Island |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de la Réunion |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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