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

Placenta Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771415
• Other study ID #: PLA-OX-1
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: February 18, 2021

Study information

• Verified date: March 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 18, 2021
• Est. primary completion date: January 15, 2021
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Placenta Diseases

Locations

Country	Name	City	State
Croatia	Hormona Polyclinic	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placental oxygenation levels	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.	During the procedure