Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01987024
First received: September 16, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.

Methods Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to our gold standard protocol. After 48 hours, they will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.

Study duration The trial period will be 36 months.

Expected results The use of detection of IGFBP-1 would enable us to select patients at risk and to decrease the duration of hospitalization in the case of a negative result.

Perspectives The negative predictive value of phIGFBP-1 test could be useful to select patients with stabilized risk of preterm labor, who could be discharged early. Moreover it could be used, in the Perinat Sud network, to decide if patients with a risk of preterm labor would benefit from hospitalization in a level II or III maternity ward.


Condition Intervention
Patients With a Risk of Preterm Labour
Device: Actim Partus® test
Other: usual procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • vaginal cervical sampling [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: October 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group A-usual procedure Other: usual procedure
Experimental: groupB- actim partus Device: Actim Partus® test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Women aged 18 years or more,

    • Women with a single intrauterine pregnancy with a term consistent with the LMP and / or ultrasound of the first quarter,
    • Women with a pregnancy in which the term is greater than 24 weeks and strictly less than 34 weeks,
    • initially consultant Woman (D0):
  • For painful uterine contractions associated with ultrasound measurement of a neck (LC) of less than 25 mm,
  • Or cervical changes discovered incidentally during a vaginal examination confirmed by LC <25 mm,
  • Or during a routine ultrasound with LC <25 mm;
  • Patient with a MAP stabilized in terms Clinical Ultrasound in D2:

Clinical criteria: absence of painful uterine contractions described or strictly less than 3 uterine contractions recorded during an external électrocardiotocographie for 30 minutes; And sonographic criteria: cervicométrie measured steady J2 (+ / - 10%) or increased relative to the cervicométrie J0.

- Women who have signed a written informed consent.

Exclusion Criteria:

  • - Minor Female,
  • Women with a multiple pregnancy,
  • Women with a pathological whose late intrauterine growth preeclampsia, fetal malformations, maternal-fetal immunizations, abnormal amount of amniotic fluid (polyhydramnios / oligohydramnios), abnormal insertion of pregnancy placenta (low inserted / previa acreta / percreta)
  • Women with pregnancy circled,
  • Women with premature rupture of membranes or signs of chorioamnionitis,
  • Women with bleeding irregularities,
  • Women with uterine malformation (septate uterus, bicornuate, polyfibromateux)
  • Women are not affiliated with the social security system,
  • Women who can not receive an informed information
  • Women who have not signed the informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987024

Contacts
Contact: cecile chau cecile.chau@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: cecile chau       cecile.chau@ap-hm.fr   
Principal Investigator: cecile chau         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01987024     History of Changes
Other Study ID Numbers: 2013-A00780-45, 2013-21
Study First Received: September 16, 2013
Last Updated: July 23, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des Produits de Sant

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 20, 2014