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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Study Description
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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.


Condition or disease Intervention/treatment Phase
Premature Delivery Device: Vaginal swabbing Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Threat of premature delivery
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Samir MEDJANE, PhD +262 (0)262906286 samir.medjane@chu-reunion.fr
Contact: Valérie Fontaine +262 (0)262906283 drci@chu-reunion.fr

Locations
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France
CHU de La Réunion - site Nord Recruiting
Saint-Denis, Reunion Island, France, 97400
Contact: Vanessa Benassi, MD       drci@chu-reunion.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
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Principal Investigator: Vanessa BENASSI, MD CHU de La Réunion
More Information
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT02904070    
Other Study ID Numbers: 2013/CHU/07
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de la Réunion:
Threat of
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications