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Prediction of Spontaneous Onset of Labor at Term (PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05109247
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : January 3, 2022
Sponsor:
Collaborators:
Hologic, Inc.
QIAGEN Gaithersburg, Inc
Pregnolia AC
Information provided by (Responsible Party):
Federico Migliorelli, University Hospital, Geneva

Brief Summary:
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.

Condition or disease
Labor, Induced Labor, Obstetric Labor Onset Predictive Model

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 429 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Prediction of Spontaneous Onset of Labor at Term
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022



Primary Outcome Measures :
  1. Spontaneous versus induced onset of labor [ Time Frame: 3 weeks ]
    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


Secondary Outcome Measures :
  1. Gestational age at spontaneous onset of labor [ Time Frame: 2 weeks ]
    Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor

  2. Gestational age at spontaneous onset of labor [ Time Frame: 1 week ]
    Time from sample collection at 40 weeks of pregnancy to spontaneous onset of labor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women at 38+5 - 39 weeks of gestation who will deliver at the centers in which the study will be carried out.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05109247


Contacts
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Contact: Federico E Migliorelli, MD, PhD +34 607 31 32 57 Federico.Migliorelli@hcuge.ch
Contact: Begoña Martinez de Tejada, MD, PhD +41 22 372 64 79 Begona.MartinezDeTejada@hcuge.ch

Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: David Desseauve, MPH, MD, PhD    +41 (0) 79 556 82 59    David.Desseauve@chuv.ch   
Universitätsspital Basel Not yet recruiting
Basel, Switzerland, 4031
Contact: Franziska GEISSLER, MD    +41 61 328 58 84    franziska.geissler@usb.ch   
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland, 1211
Contact: Catherine McCarey, MD    +41 79 553 28 40    Catherine.Mccarey@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Hologic, Inc.
QIAGEN Gaithersburg, Inc
Pregnolia AC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Federico Migliorelli, Obstetrician, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT05109247    
Other Study ID Numbers: 19-261
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No