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Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies

Sponsor
University of Palermo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05771415
Collaborator
(none)
34
Enrollment

Study Details

Study Description

Brief Summary

The aim was to compare placental oxygenation in low risk, uncompli-cated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale.

The study included 34 singleton subjects divided into two groups accord-ing to placental maturation: low grade (Grannum 0-1; n=10) and high grade (Gran-num 2-3; n=24). In each study subjects, measurement was performed at two sites: (a) test site above the central part of the placenta, and (b) control site out of placenta on lower abdomen, in medial line, 3 cm from the symphysis. Student's t-test was used to compare tissue oxygenation index (TOI) values among the study groups. The normality of distribution was demonstrated by the Kolmogorov-Smirnov test.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    34 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Grannum placental maturity grade 0 and 1 (low maturity level

    Women with low placental maturity grade (group 1, Grannum 0-1)
    Grannum placental maturity grade 2 and 3 (high maturity level)

    Women with high placental maturity grade (group 2, Grannum 2-3)

    Outcome Measures

    Primary Outcome Measures

    1. Placental oxygenation levels [During the procedure]

      to compare placental oxygenation in low risk, uncomplicated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    singleton low-risk, uncomplicated, term pregnancies (37th to 41+6 weeks of gestation), anterior placental localization and abdominal wall of less than 3cm thickness.

    Exclusion Criteria:

    complicated, pre-term pregnancies. Abdominal wall tick > 3cm

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Palermo

    Investigators

    • Principal Investigator: Mislav Mikuš, M.D., Clinical Hospital Centre Zagreb
    • Study Chair: Antonio Simone Laganà, M.D. Ph.D., University of Palermo
    • Study Chair: Andrea Etrusco, M.D, University of Palermo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Etrusco, Principal investigator, University of Palermo
    ClinicalTrials.gov Identifier:
    NCT05771415
    Other Study ID Numbers:
    • PLA-OX-1
    First Posted:
    Mar 16, 2023
    Last Update Posted:
    Mar 16, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andrea Etrusco, Principal investigator, University of Palermo
    Near-Infrared Spectroscopy
    Placenta oxigenations
    Placenta maturity
    Additional relevant MeSH terms:
    Placenta Diseases

    Study Results

    No Results Posted as of Mar 16, 2023