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PREDICT: Prediction of Spontaneous Onset of Labor at Term

Sponsor
University Hospital, Geneva (Other)
Overall Status
Recruiting
CT.gov ID
NCT05109247
Collaborator
Hologic, Inc. (Industry), QIAGEN Gaithersburg, Inc (Industry), Pregnolia AC (Other)
429
Enrollment
3
Locations
33.3
Anticipated Duration (Months)
143
Patients Per Site
4.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    429 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Spontaneous Onset of Labor at Term
    Actual Study Start Date :
    Aug 22, 2019
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Spontaneous versus induced onset of labor [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 [2 weeks]

      Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor

    2. Gestational age at spontaneous onset of labor [1 week]

      Time from sample collection at 40 weeks of pregnancy to spontaneous onset of labor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire Vaudois Lausanne Vaud Switzerland 1011
    2 Universitätsspital Basel Basel Switzerland 4031
    3 Hôpitaux Universitaires de Genève Geneva Switzerland 1211

    Sponsors and Collaborators

    • University Hospital, Geneva
    • Hologic, Inc.
    • QIAGEN Gaithersburg, Inc
    • Pregnolia AC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Federico Migliorelli, Obstetrician, Principal Investigator, University Hospital, Geneva
    ClinicalTrials.gov Identifier:
    NCT05109247
    Other Study ID Numbers:
    • 19-261
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 3, 2022