Prediction of Spontaneous Onset of Labor at Term

Study Overview
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Brief Summary
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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.

Official Title
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Prediction of Spontaneous Onset of Labor at Term

Conditions
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Labor, Induced, Labor, Obstetric, Labor Onset, Predictive Model

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alive fetus Singletons Cephalic presentation Intact membranes Gestational age ≥ 38 weeks and 5 days Exclusion Criteria: Fetal malformations Symptomatic uterine contractions Contraindication for vaginal delivery Medical indication of induction of labor or elective cesarean delivery Maternal desire to induce labor Maternal negative to enrollment Language barrier Inability to give consent 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: Nabothian cyst Cervical myomas Cervical condylomas Squamous intraepithelial lesion Conization/LEEP2/LLETZ3 Cervical endometriosis Cervical tears Cervical dysplasia Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 week |