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

Preterm Birth Clinical Trial

— MAPOSURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401255
• Other study ID #: RC17_0247
• Status: Completed
• Start date: February 28, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• < 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.
• 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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth
• Preterm Labor

Intervention

Other:
• Partosure test
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.

Locations

Country	Name	City	State
France	La Roche-sur-yon University Hospital	La Roche-sur-Yon
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	time to delivery
Secondary	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.	time to delivery
Secondary	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.	time to delivery
Secondary	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.	time to delivery
Secondary	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	time to delivery
Secondary	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.	within 48 hours after delivery
Secondary	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.	within 7days after delivery
Secondary	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.	within 48hours after delivery
Secondary	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.	7 days within after delivery
Secondary	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.	time to delivery
Secondary	hospital stays	Economic impact evaluation	time to delivery
Secondary	PAMG-1 tests consumption	Economic impact evaluation	time to delivery
Secondary	corticosteroid treatments consumption	Economic impact evaluation	time to delivery
Secondary	tocolytic treatments consumption	Economic impact evaluation	time to delivery