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| Name | Class |
|---|---|
| Hologic, Inc. | INDUSTRY |
| QIAGEN Gaithersburg, Inc | INDUSTRY |
| Pregnolia AC | UNKNOWN |
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The study intends to develop a predictive model of spontaneous onset of labor between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date. The main hypothesis is that a combination of clinical, ultrasonographic, biochemical and/or biophysical variables will allow to differentiate women who will spontaneously trigger their labors from those who will require an induction by the term of their pregnancies. A tool of this kind should aid in the individualization of the management of the final weeks of pregnancy and, at the light of recent evidence, provide support to the decision-making processes.
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| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous versus induced onset of labor | Number of participants who will spontaneously go into labor between the 39th and the 41st week of pregnancy versus number of participants requiring an induction of labor during the 41st week of pregnancy due to advanced gestational age | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at spontaneous onset of labor | Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor | 2 weeks |
| Gestational age at spontaneous onset of labor | Time from sample collection at 40 weeks of pregnancy to spontaneous onset of labor |
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Inclusion Criteria:
Exclusion Criteria:
Specific Exclusion Criteria for Pregnolia System (if any of these criteria is present, the measurement of cervical stiffness using Pregnolia aspiration device will not be performed):
Müllerian anomalies with two cervices
Severe vaginal bleeding
Cervical dilatation
Known HIV
Visible, symptomatic cervical or vaginal infections
If one of the following conditions is present on the cervix at the 12 o'clock position:
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Pregnant women at 38+5 - 39 weeks of gestation who will deliver at the centers in which the study will be carried out.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland | ||
| Universitätsspital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35830435 | Derived | Migliorelli F, Ferrero L, McCarey C, Marcenaro S, Othenin-Girard V, Chilin A, Martinez de Tejada B. Prediction of spontaneous onset of labor at term (PREDICT study): Research protocol. PLoS One. 2022 Jul 13;17(7):e0271065. doi: 10.1371/journal.pone.0271065. eCollection 2022. |
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| 1 week |
| Basel |
| 4031 |
| Switzerland |
| Hôpitaux Universitaires de Genève | Geneva | 1211 | Switzerland |