Evaluation of Vaginal PAMG-1 Detection by PartoSure Test in Preterm Delivery Threat in Actual Clinical Situation: Randomized Controlled Trial

NCT ID: NCT03675061

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2021-02-23

Brief Summary

Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great prematurity). More than half of these births follow spontaneous work.

Before 34 weeks of amenorrhea, prematurity requires specific maternal-fetal management centered primarily on antenatal corticosteroid treatment for fetal maturation including 2 intramuscular injections at 24 hour intervals. This cure can only be done once and its benefit is proven in the 7 (to 14) days before the birth (recommendation for the clinical practice of the French National College of Obstetricians and Gynecologists of December 2016). The single course of antenatal corticosteroids before 34 weeks of amenorrhea is associated in the neonatal period with reduction in morbidity and mortality, and in the long term with an improvement of the survival without sequelae, if the full cure is administered in the 7, to 14, days before birth. The second key element of the management of a premature delivery threats is the admission in a pediatric structure adapted to the degree of prematurity.

The care of a premature delivery threats before 34 weeks of amenorrhea care leads to hospitalization with possible transfer to a maternity of pediatric adapted level, tocolysis, a biological and bacteriological assessment, and, sometimes, other examinations and treatments.

The prediction of premature labor is a challenge. Current methods, such as vaginal examination, cervicometry and detection of fetal fibronectin, make it possible to obtain a negative predictive value (NPV) approaching 100% but a poor positive predictive value (PPV), thus 8 out of 10 patients hospitalized and treated for premature delivery threat no not give birth within 7 days, or even before 34 weeks of amenorrhea. A better prediction of preterm delivery has two benefits: administer antenatal corticosteroid therapy in high-risk patients at the right time and not treat not-at risk patients.

The PartoSure® test, which detects the placental protein vaginal alphamicroglobulin-1 (PAMG-1), has satisfactory metrological qualities according to observational studies : NPV 98% and PPV 75% of delivery within 7 days.

However this test has never been evaluated in real clinical condition. In our study, the result of the test becomes decisional for the care.

The hypothesis is that use of this test will improve the prediction of preterm delivery during a first consultation for preterm delivery threat and thus allow more frequent prenatal corticosteroid treatment in optimal period, avoiding treating non-at risk patients.

Conditions

Pregnancy Preterm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Current care : The management of the preterm delivery risk without biochemical test, with hospitalization of the patient, initiation of tocolysis and a complete corticosteroid treatment.

Group Type: OTHER

Current care

Intervention Type: OTHER

Tocolysis and a complete corticosteroid treatment.

PartoSure group

Each women have a biochemical test = PartoSure Test.

• PartoSure test negative : For a negative test, the patient will be able to benefit from a nifedipine tocolysis, if the uterine contractions require it, then she will return home with a control by a midwife at home twice a week up to 34 weeks of amenorrhea.
• PartoSure test positive : For a positive test, the patient will be hospitalized 7 days with a care identical to the control group.

Group Type: OTHER

PartoSure Test negative

Intervention Type: DEVICE

Biochemical test and nifedipine tocolysis, then return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea .

PartoSure Test positive

Intervention Type: DEVICE

Biochemical test and tocolysis and a complete corticosteroid treatment. then if situation is stable, return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea

Interventions

Current care

Tocolysis and a complete corticosteroid treatment.

Intervention Type: OTHER

PartoSure Test negative

Biochemical test and nifedipine tocolysis, then return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea .

Intervention Type: DEVICE

PartoSure Test positive

Biochemical test and tocolysis and a complete corticosteroid treatment. then if situation is stable, return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Major patient
• Pregnant of a singleton
• Followed at Brest hospital and resident unless 30 kms of Hospital
• Patient consultant for preterm delivery threat before 34 weeks of amenorrhea with more than 6 contractions per hour (ie 1 in 10 minutes) felt and / or sensed by external toco-ergometry associated with cervical changes objectified by a measurement of the cervix by ultrasound between 15 and 25 mm
• With capacity of a free and informed consent
• Affiliated member of the French social security system

Exclusion Criteria

• Patient transferred for preterm delivery from a peripheral hospital center
• Patient not followed at Brest hospital
• Patient doesn't lives within 30 km of the Brest hospital
• Clinical premature rupture of membranes
• Circled patients
• Important metrorrhagia
• Cervix <15 mm
• Cervical dilatation > 3 cm
• Isolated short cervix defined by a short cervix in measurement of the cervix by ultrasound without uterine contraction felt or captured in external toco-ergometry
• Placenta previa, placenta percreta
• Multiple pregnancy
• Suspicion of chorioamnionitis
• Associated maternal-fetal pathology that may induce prematurity
• No prenatal corticosteroid treatment for this pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Brest

Brest, , France

Countries

France

Other Identifiers

29BRC17.0203 - PARTO-MAP

Identifier Type: -

Identifier Source: org_study_id