Placenta Diseases Clinical Trial
Official title:
Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies
NCT number | NCT05771415 |
Other study ID # | PLA-OX-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | February 18, 2021 |
Verified date | March 2023 |
Source | University of Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | February 18, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Hormona Polyclinic | Split |
Lead Sponsor | Collaborator |
---|---|
University of Palermo |
Croatia,
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 |
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