Placenta AccretaNCT04525534
Plasma Concentration of Biological Markers in Placenta Accreta Spectrum
An observational study of Placenta Accreta and Placenta Diseases, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta, Placenta Diseases
- What is being tested?
- There is no other intervention, only clinical treatment.
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2020to 10 Jul 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Mother-infant dyads with suspected or confirmed diagnosis of PAS and healthy mother-infant dyads admitted for cesarean delivery
Who may be able to join
- Age 18 - to 45-years old, inclusive
- Suspected or confirmed PAS or phenotypically matched controls
- Delivery by cesarean section
- Gestational age greater than 28 weeks
- Singleton pregnancy
Who cannot join
- Intrauterine fetal demise,
- Severe fetal anomalies (infant not expected to survive)
- Emergent cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Plasma Concentration of Biological Markers in Placenta Spectrum
The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.
Read the detailed description
Maternal blood samples will be taken at various points during the intrapartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.
- Conditions
- Placenta Accreta, Placenta Diseases
- Being tested
- There is no other intervention, only clinical treatment.
- Medical subject headings
- Placenta Accreta, Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no other intervention, only clinical treatment.Other
There is no other intervention, only clinical treatment
| Study group | Role | What they receive |
|---|---|---|
| Placenta accreta spectrum | Mother-infant dyads with suspected or confirmed diagnosis of placenta accreta spectrum Receives: Other: There is no other intervention, only clinical treatment. | |
| Phenotypically-matched controlled group | Mother-infant dyads admitted for delivery without placenta accreta spectrum Receives: Other: There is no other intervention, only clinical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the level of placental-derived MPs (Microparticles/mL)
Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.
Measured: Up to 6 hours
Identify biomarkers (picogram/mL)
Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.
Measured: Up to 6 hours
Secondary outcomes (1)
Is there a correlation between maternal serum total placental MPs and biomarkers to the International Federation of Gynecology and Obstetrics (FIGO) classification for PAS at the time of cesarean delivery.
Examine the correlation between maternal serum total placental MPs and biomarkers to the FIGO classification
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start30 Aug 2020
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Why it stopped: difficulties with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadir e Sharawi, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525534
- Sponsor's protocol ID
- 261299
- Status last verified
- Nov 2023
- First submitted
- 20 Aug 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Concentration of Biological Markers in Placenta Spectrum
- ClinicalTrials.gov ID
- NCT04525534
- Acronym / sponsor ID
- 261299
- Conditions
- Placenta Accreta, Placenta Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulties with enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 25 Aug 2020 (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 purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.
Detailed description
Maternal blood samples will be taken at various points during the intrapartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placenta accreta spectrum | – | Other: There is no other intervention, only clinical treatment.Mother-infant dyads with suspected or confirmed diagnosis of placenta accreta spectrum |
| Phenotypically-matched controlled group | – | Other: There is no other intervention, only clinical treatment.Mother-infant dyads admitted for delivery without placenta accreta spectrum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mother-infant dyads with suspected or confirmed diagnosis of PAS and healthy mother-infant dyads admitted for cesarean delivery
Key inclusion criteria (5 listed)
- Age 18 - to 45-years old, inclusive
- Suspected or confirmed PAS or phenotypically matched controls
- Delivery by cesarean section
- Gestational age greater than 28 weeks
- Singleton pregnancy
Key exclusion criteria (3 listed)
- Intrauterine fetal demise,
- Severe fetal anomalies (infant not expected to survive)
- Emergent cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no other intervention, only clinical treatment.There is no other intervention, only clinical treatment | Other | Phenotypically-matched controlled group, Placenta accreta spectrum |
Primary outcome
Determine the level of placental-derived MPs (Microparticles/mL)
Time frame: Up to 6 hours
Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.
Identify biomarkers (picogram/mL)
Time frame: Up to 6 hours
Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.
1 secondary outcome
Is there a correlation between maternal serum total placental MPs and biomarkers to the International Federation of Gynecology and Obstetrics (FIGO) classification for PAS at the time of cesarean delivery.
Time frame: Up to 6 hours
Results and safety
The study was stopped early (reason given: difficulties with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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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.
Nadir e Sharawi, MD principal investigator
UAMS
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 Accreta and Placenta Diseases, run by University of Arkansas at 1 site in United States.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Sep 2024. 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 United States. 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 was stopped early (reason given: difficulties with enrollment). Results are not available in the source record.
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?
Determine the level of placental-derived MPs (Microparticles/mL) (time frame: Up to 6 hours). The study lists 2 primary outcomes in all. 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 3 Sep 2024.