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

U

University of Palermo

Status

Completed

Conditions

Placenta Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT05771415
PLA-OX-1

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

34 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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