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Preterm LaborMAPOSURENCT03401255

Interest of a Vaginal Swab in Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth

An observational study of Preterm Labor and Preterm Birth, run by Nantes University Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preterm labor is the first cause of hospitalization during the pregnancy, and at the origin of more than 60 000 births before 37 weeks of amenorrhea every year in France. It is however difficult to predict if a patient consulting in emergencies with symptoms of preterm labor, will give birth prematurely or not. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Preterm Labor, Preterm Birth
What is being tested?
Partosure test
How many people
341 participants
Where
2 sitesFrance
Study dates
28 Feb 2018to 28 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: patients presenting symptoms of preterm labor

Who may be able to join

  • patients presenting for emergency obstetrical care with signs suggestive of preterm labor
  • single pregnancy
  • gestational age between 24 + 0 and 33SA + 6 weeks of gestation
  • cervical length ≤ 25mm measurement on transvaginal ultrasound with or without uterine contraction
  • informed consent
  • consenting to be part of the trial

Who cannot join

  • < 18 years old or patient under guardianship / curators
  • multiple pregnancy
  • gestational term less than 24 SA or greater than or equal to 34 SA
  • heavy vaginal bleeding- antecedent of conisation
  • uterine malformation ( bicervical-bicorn uterus, unicervical bicorn uterus, unicorn uterus, septate uterus)
  • Cervical dilatation >3 cm.
Show all 13Show fewer
  • cervical length with transvaginal ultrasound >25mm
  • presence of a hydramnios with a superior amniotic fluid index 25
  • premature rupture of manifest membranes (PROM)
  • clinical or biological chorioamnionitis
  • hooping cervical
  • intercurrent obstetric pathology that can induce premature birth
  • patient hospitalized for more than 24 hours in another hospital or service for preterm labor diagnosis

Trial locations and contacts

2 sites in 1 country.

France2 sites
  • La Roche-sur-yon University Hospital

    La Roche-sur-Yon, 85191

  • Nantes University Hospital

    Nantes, 44093

Other trials in France

About this study

Official title: Prospective Multicentric Study Estimating the Interest of a Vaginal Swab in Detection of Placental Alpha-Microglobulin-1 (Partosure®) in the Prediction of Preterm Birth

Preterm labor is the first cause of hospitalization during the pregnancy, and at the origin of more than 60 000 births before 37 weeks of amenorrhea every year in France. It is however difficult to predict if a patient consulting in emergencies with symptoms of preterm labor, will give birth prematurely or not. Current diagnostic tools to identify patients with high risk of premature delivery in 7 days are insufficient because of their low positive predictive value. Yet the neonatal complications in case of premature delivery are important, with respiratory distress syndrome, hyaline membrane disease, necrotizing enterocolitis, intraventricular hemorrhage and post-natal death. Recent studies suggested that the detection of the placental alpha microglobulin 1 (PAMG-1) in the vaginal secretions, by Partosure® test at the women presenting symptoms of preterm labor with intact membranes would indicate that a premature spontaneous delivery could arise in 7 days with a good positive predictive value.The test is interesting all the more as the repetition of the prenatal cures of corticosteroids, aiming at the fetal lung maturation, is this day more recommended and as the beneficial effect takes place within 24 hours in 7 days following their administration. It seems thus essential to make studies to specify the interest of this test at the patients presenting a preterm labor. This study aims at estimating the diagnostic performance of the test of detection of PAMG-1 in the prediction of a delivery in 7 days, at the patients presenting symptoms of preterm labor.

Read the detailed description

Preterm labor is the first cause of hospitalization during the pregnancy and complicates of a premature delivery in about 30 % of the cases during single pregnancy. It is about a clinical situation arising between 22 and 36 amenorrhea weeks (SA) + 6 days, which are observed the cervical modifications and the uterine contractions confirmed by an ultrasound measure with cervical length ≤25mm.The main complication of the threat premature delivery (MAP) is the premature birth, which is an essential factor of perinatal morbidity and is the second cause of death before the age of 5 years. The measure of cervical length with ultrasound and the detection of the fetal fibronectin were estimated to identify the patients with risk of spontaneous premature delivery, however their capacity to discriminate these patients is insufficient (predictive value is positive of 20 %). It thus seems necessary to find a diagnostic alternative more relevant.The prenatal corticosteroid therapy is recommended for all the patients at risk of premature delivery in 7 days between 24 and 34 SA. Indeed the maximal profit of corticoids arises when the delivery occurs between 12 hours and 7 days following their administration, with a significant reduction in neonatal period the hyaline membrane diseases (50 %), intraventricular hemorrhage, necrotizing enterocolitis and deaths (40 %). Thus corticosteroids establishes the most important treatment in the prematurity.However, the beneficial effect of the corticosteroid therapy decreases if the birth arises beyond 7 days after the administration. So the efficiency of a complete cure of corticoids in the prevention of the neonatal respiratory morbidity is in connection with deadline between the administration and the delivery. The challenge consists in administering the cure of corticoids in 7 days preceding the birth to benefit from the maximal neonatal profit. Besides, the repetition of the cures of corticoids could be responsible for noxious effects on the future of the future adult by distorting the growth of the child and its cognitive future, by increasing the risk of obesity or insulin resistance, as well as the cardiovascular risk in the adulthood.The capacity to discriminate between the patients who are going to give birth prematurely in 7 days so answers a double objective: allow the implementation of an effective and beneficial preventive treatment for the newborn child and avoid treatments and inconvenient hospitalizations, generators of unwanted effects and useless spending.A recent study estimates the interest of an interesting molecule, the placental alpha microglobulin 1 (PAMG-1), in this diagnostic approach. She concludes that the detection of PAMG-1 by a vaginal taking is the best test to predict spontaneous delivery in 7 days compared with the measure of the cervical length by transvaginal ultrasound and the test of fetal fibronectin. If the performance of the test is validated by the study, the coverage of the patients would be optimized with less frequent and less long hospitalizations, as well as a decrease of treatments pointlessly prescribed at the patients not giving birth finally prematurely (tocolytics, corticoids). For those giving birth prematurely, corticoids could be administered for an optimal deadline to obtain the maximal profit for the newborn child.

Being tested
Partosure test
Keywords
Placental alpha microglobulin-1, PAMG-1, preterm labor, preterm delivery, preterm birth, cervical length, transvaginal ultrasound, corticosteroid
Medical subject headings
Obstetric Labor, Premature, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Partosure testOther

    To perform the analysis, a sample of cervicovaginal secretions is collected using a vaginal swab provided in the PAMG-1 Detection Test Kit.After removing the swab from its packaging, hold the swab in the middle of the stem and carefully insert the end of the swab into the vagina over a length of 5-7cm (using a speculum). Is not necessary for sampling), when the patient is lying down.Remove the swab from the vagina after 30 seconds. Once the swab has been removed, immediately place the end in the solvent vial provided for this purpose, then rinse the swab by repeating several rotations for 30 seconds. The strip is removed as soon as two bands are clearly visible in the test area, or after 5 minutes.Two bands in the test area indicate a positive result, while a line in the test area indicates a negative result. It is not recommended to read or interpret results beyond 10 minutes of immersion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. diagnostic performance of detection test of PAMG-1 for the prediction of imminent spontaneous preterm delivery within 7 days in patients presenting with symptoms of preterm labor

    The diagnostic performance of the test will be evaluated by estimating its specificity.

    Measured: time to delivery

Secondary outcomes (13)
  1. sensitivity of detection test of PAMG-1

    To evaluate the diagnostic performance (sensitivity) of detection test of PAMG-1 for the prediction of imminent spontaneous preterm delivery within 7 days in patients presenting with symptoms of preterm labor.

    Measured: time to delivery

  2. positive predictive of detection value test of PAMG-1

    : To evaluate the diagnostic performance (positive predictive value) of detection test of PAMG-1 for the prediction of imminent spontaneous preterm delivery within 7 days in patients presenting with symptoms of preterm labor.

    Measured: time to delivery

  3. negative predictive of detection value test of PAMG-1

    To evaluate the diagnostic performance (negative predictive value) of detection test of PAMG-1 for the prediction of imminent spontaneous preterm delivery within 7 days in patients presenting with symptoms of preterm labor.

    Measured: time to delivery

  4. diagnostic performance of detection test of PAMG-1 in the prediction of imminent spontaneous preterm delivery within 48 hours in patients presenting with symptoms of preterm labor.

    The result of PAMG-1 test at the time of hospitalization (positive / negative), interval between hospitalization and delivery +/- 48 hours will be collected

    Measured: time to delivery

  5. cervical length at inclusion

    Delivery within 48 hours if cervical length is less than 15 mm, 15-19 mm and 20-25 mm at the time of inclusion and delivery within 48 hours if gestational age is between 24 weeks of amenorrhea (SA) and 27 SA + 6, 28 SA and 31 SA + 6, 32 SA and 33 SA + 6 at the time of inclusion and the result of PAMG-1 test will be recorded.

    Measured: within 48 hours after delivery

  6. cervical length at inclusion

    Delivery within 7 days if cervical length is less than 15 mm, 15-19 mm and 20-25 mm at the time of inclusion and delivery within 7 days if gestational age is between 24 SA and 27 SA + 6, 28 SA and 31 SA + 6, 32 SA and 33 SA + 6 at the time of inclusion and the result of PAMG-1 test will be recorded.

    Measured: within 7days after delivery

  7. gestational age at inclusion

    Delivery within 48 hours if cervical length is less than 15 mm, 15-19 mm and 20-25 mm at the time of inclusion and delivery within 48 hours if gestational age is between 24 SA and 27 SA + 6, 28 SA and 31 SA + 6, 32 SA and 33 SA + 6 at the time of inclusion and the result of PAMG-1 test will be recorded.

    Measured: within 48hours after delivery

  8. gestational age at inclusion

    Delivery within 7 days if cervical length is less than 15 mm, 15-19 mm and 20-25 mm at the time of inclusion and delivery within 7 days if gestational age is between 24 SA and 27 SA + 6, 28 SA and 31 SA + 6, 32 SA and 33 SA + 6 at the time of inclusion and the result of PAMG-1 test will be recorded.

    Measured: 7 days within after delivery

  9. False positives.

    evaluate factors associated for patients with a positive test who did not give birth within 7 days Gestational age less than 34 weeks and 37 weeks at the time of birth.

    Measured: time to delivery

  10. hospital stays

    Economic impact evaluation

    Measured: time to delivery

  11. PAMG-1 tests consumption

    Economic impact evaluation

    Measured: time to delivery

  12. corticosteroid treatments consumption

    Economic impact evaluation

    Measured: time to delivery

  13. tocolytic treatments consumption

    Economic impact evaluation

    Measured: time to delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start28 Feb 2018
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03401255
Sponsor's protocol ID
RC17_0247
Acronym
MAPOSURE
Status last verified
Sep 2022
First submitted
3 Jan 2018
Last updated
8 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Marie E, Ducarme G, Boivin M, Badon V, Pelerin H, Le Thuaut A, Lamoureux Z, Riche VP, Winer N, Thubert T, Dochez V. The value of a vaginal sample for detecting PAMG-1 (Partosure(R)) in women with a threatened preterm delivery (the MAPOSURE Study): protocol for a multicenter prospective study. BMC Pregnancy Childbirth. 2020 Aug 3;20(1):442. doi: 10.1186/s12884-020-03129-x.

    PubMed 32746802

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Labor and Preterm Birth, run by Nantes University Hospital at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diagnostic performance of detection test of PAMG-1 for the prediction of imminent spontaneous preterm delivery within 7 days in patients presenting with symptoms of preterm labor (time frame: time to delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03401255, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.

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