Placenta DiseasesNCT05771415
Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies
An observational study of Placenta Diseases, run by University of Palermo at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Diseases
- How many people
- 34 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2019to 18 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- complicated pregnancies pre-term pregnancies Abdominal wall tick > 3cm
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Oct 2019
- Primary completion15 Jan 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
- Investigators
- Mislav Mikuš, M.D., Principal investigator, Clinical Hospital Centre ZagrebAntonio Simone Laganà, M.D. Ph.D., Study chair, University of PalermoAndrea Etrusco, M.D, Study chair, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771415
- Sponsor's protocol ID
- PLA-OX-1
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies
- ClinicalTrials.gov ID
- NCT05771415
- Acronym / sponsor ID
- PLA-OX-1
- Conditions
- Placenta Diseases
- Keywords
- Near-Infrared Spectroscopy, Placenta oxigenations, Placenta maturity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- complicated pregnancies pre-term pregnancies Abdominal wall tick > 3cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Placental oxygenation levels
Time frame: During the procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mislav Mikuš, M.D. principal investigator
Clinical Hospital Centre Zagreb
Antonio Simone Laganà, M.D. Ph.D. study chair
University of Palermo
Andrea Etrusco, M.D study chair
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Diseases, run by University of Palermo at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placental oxygenation levels (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.