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

NCT05771415 | Completed

• 1 other identifier: PLA-OX-1
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Diseases

Keywords

Near-Infrared Spectroscopy; Placenta oxigenations; Placenta maturity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women with singleton low-risk, uncomplicated, term pregnancies anterior placental localization and abdominal wall of less than 3cm thickness. US and Doppler studies, as well as CTG and laboratory findings were normal in all study women.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Hormona Polyclinic

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Placenta Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mislav Mikuš, M.D.

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà, M.D. Ph.D.

  University of Palermo

  STUDY CHAIR

• Andrea Etrusco, M.D

  University of Palermo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 16, 2023
• Study Start: October 1, 2019
• Primary Completion: January 15, 2021
• Study Completion: February 18, 2021
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CR (1)