Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.
Primary Purpose
Patients With a Risk of Preterm Labour
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Actim Partus® test
usual procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients With a Risk of Preterm Labour
Eligibility 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.
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
group A-usual procedure
groupB- actim partus
Arm Description
Outcomes
Primary Outcome Measures
vaginal cervical sampling
Secondary Outcome Measures
Full Information
NCT ID
NCT01987024
First Posted
September 16, 2013
Last Updated
September 23, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01987024
Brief Title
Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.
Official Title
Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
March 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With a Risk of Preterm Labour
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A-usual procedure
Arm Type
Active Comparator
Arm Title
groupB- actim partus
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Actim Partus® test
Intervention Type
Other
Intervention Name(s)
usual procedure
Primary Outcome Measure Information:
Title
vaginal cervical sampling
Time Frame
36 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.
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