Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)

ConditionPreterm Labor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of this study is to clinically validate the predictive performance (sensitivity and specificity) of the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in the target population of women consulting obstetric emergencies for preterm labor (PTL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant with live fetus(es)

Emergency room visit between 22 and 34 days of pregnancy + 6 days

Uterine contractions (UC) objectified during the consultation (questioning, clinical examination, external tocography),

And/or clinical or ultrasound changes of the uterine cervix;

Disqualifiers

Age < 18 years;

Premature rupture of membranes

Patient in labor with imminent delivery.

Total absence of social care

Trial design

Design model

Single group

Treatments tested in this trial

  • Collection of vaginal secretions

    Biological/Vaccine

    In all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.

  • Collection of the placenta and the membranes

    Biological/Vaccine

    In cohort 1, for 30 patients at the Port Royal Maternity Hospital, the placenta and membranes will be collected after delivery

  • Administration of EPDS questionnaire

    Other intervention

    In cohort 3, the EPDS questionnaire will be administered to all participants after the consultation in the emergency department.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Delivery occurence 7 days after inclusion

Time frame
Cohort 1 : assessed 15-21 days after inclusion of each patient. Cohort 3: assessed after end of follow-up (5.5 months).

Secondary outcomes

1

delivery occurrence 14 days after consultation

Time frame
assessed after end of follow-up (5.5 months)
2

delivery <32 weeks of gestation, <34 weeks and <37 weeks

Gestational age at delivery, in 4 categories.

Time frame
assessed after end of follow-up (5.5 months)
3

neonatal mortality;

Time frame
assessed after end of follow-up (5.5 months)
4

severe neonatal morbidity

Defined by one or more of the following : * Bronchopumonary dyplasia * Necrotizing enterocolitis stage 2 or 3 * Intraventricular haemorrhage stage 3-4 * Periventricular leukomalacia * Retinopathy of prematurity stage \>3

Time frame
assessed after end of follow-up (5.5 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator