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CompletedNCT05771415

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

Status
Completed
Phase
Study type
Observational
Enrollment
34 (actual)
Sponsor
University of Palermo · Academic / Other
Sex
Female
Age
Healthy volunteers

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.

Conditions

Timeline

Start date
2019-10-01
Primary completion
2021-01-15
Completion
2021-02-18
First posted
2023-03-16
Last updated
2023-03-29

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT05771415. Inclusion in this directory is not an endorsement.

Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiolog (NCT05771415) · Clinical Trials Directory