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

NCT01987024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-09-28

No results posted yet for this study

Summary

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.

Conditions

  • Patients With a Risk of Preterm Labour

Interventions

DEVICE

Actim Partus® test

OTHER

usual procedure

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • LOIC MONDOLONI · Assistance Publique Hopitaux De Marseille

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-09-16
Completion
2020-03-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01987024 on ClinicalTrials.gov