Abruptio PlacentaeNCT03782168
Plasma Concentration of Biological Markers in Placental Abruption
An observational study of Abruptio Placentae, run by University of Arkansas at 1 site in United States.
Trial summary
This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abruptio Placentae
- What is being tested?
- There is no other intervention, only clinical treatment.
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 1 Aug 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and healthy mother-infant dyads admitted for delivery.
Who may be able to join
- Age 18 - to 45-years old, inclusive
- Suspected or confirmed PA or phenotypically matched controls
- All modes of delivery
- Gestational age greater than 28 weeks
- Singleton pregnancy
Who cannot join
- Intrauterine fetal demise,
- Severe fetal anomalies (infant not expected to survive)
- Inability to communicate in English
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
This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum 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 (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1), vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if will examine the correlation between placental micro-particles, biomarkers, and extent of placental abruption.
Read the detailed description
The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. The knowledge gained from this study has the potential to develop a diagnostic test for PA with the ability to improve outcomes for mother and baby through earlier diagnosis and targeted therapy.
- Conditions
- Abruptio Placentae
- Being tested
- There is no other intervention, only clinical treatment.
- Medical subject headings
- Abruptio Placentae
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
The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA.
| Study group | Role | What they receive |
|---|---|---|
| Placental Abruption | Mother-infant dyads with suspected or confirmed diagnosis of placental abruption Receives: Other: There is no other intervention, only clinical treatment. | |
| Phenotypically-matched controlled group | Healthy mother-infant dyads admitted for delivery 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 PA compared to 10 matched control subjects.
Measured: Up to 75 minutes
Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng)
Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.
Measured: Up to 75 minutes
Secondary outcomes (1)
Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.
In order to evaluate the secondary outcome, the correlation between maternal serum total placental MPs, biomarkers to clinical symptomology, and the severity of placental abruption after delivery will be examined.
Measured: Up to 75 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start31 Jan 2019
- Primary completion31 Jan 2019
- Study completion1 Aug 2021
Why it stopped: IRB approval expired; failure to submit continuing review in time. Will re-open once IRB approval is reinstated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abruptio PlacentaeStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadir Shawrawi, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782168
- Sponsor's protocol ID
- 228485
- Status last verified
- Oct 2021
- First submitted
- 10 Dec 2018
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Placental Abruption
- ClinicalTrials.gov ID
- NCT03782168
- Acronym / sponsor ID
- 228485
- Conditions
- Abruptio Placentae
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB approval expired; failure to submit continuing review in time. Will re-open once IRB approval is reinstated.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 20 Dec 2018 (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.
This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum 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 (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1), vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if will examine the correlation between placental micro-particles, biomarkers, and extent of placental abruption.
Detailed description
The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. The knowledge gained from this study has the potential to develop a diagnostic test for PA with the ability to improve outcomes for mother and baby through earlier diagnosis and targeted therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placental Abruption | – | Other: There is no other intervention, only clinical treatment.Mother-infant dyads with suspected or confirmed diagnosis of placental abruption |
| Phenotypically-matched controlled group | – | Other: There is no other intervention, only clinical treatment.Healthy mother-infant dyads admitted for delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and healthy mother-infant dyads admitted for delivery.
Key inclusion criteria (5 listed)
- Age 18 - to 45-years old, inclusive
- Suspected or confirmed PA or phenotypically matched controls
- All modes of delivery
- Gestational age greater than 28 weeks
- Singleton pregnancy
Key exclusion criteria (3 listed)
- Intrauterine fetal demise,
- Severe fetal anomalies (infant not expected to survive)
- Inability to communicate in English
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.The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. | Other | Phenotypically-matched controlled group, Placental Abruption |
Primary outcome
Determine the level of placental-derived MPs (Microparticles/mL)
Time frame: Up to 75 minutes
Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PA compared to 10 matched control subjects.
Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng)
Time frame: Up to 75 minutes
Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.
1 secondary outcome
Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.
Time frame: Up to 75 minutes
Results and safety
The study was stopped early (reason given: IRB approval expired; failure to submit continuing review in time. Will re-open once IRB approval is reinstated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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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 Shawrawi, MD principal investigator
University of Arkansas
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 Abruptio Placentae, 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: IRB approval expired; failure to submit continuing review in time. Will re-open once IRB approval is reinstated.). 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 75 minutes). 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.