PreeclampsiaNCT03555630
Thromboelastogram in Postdelivery Preeclamptic Patients
An observational study of Preeclampsia and Coagulation Disorder, run by Augusta University at 1 site in United States.
Trial summary
There are no studies evaluating the effect of aging on hemostasis of preeclamptic patients. Additionally, although there are some studies that establish normal reference values for TEG profiles in healthy term pregnant patients, conflicting results have been found in preeclampsia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Coagulation Disorder, Pregnancy Complications
- What is being tested?
- Thromboelastogram
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2018to 31 Dec 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Term pregnant patients with preeclampsia
Who may be able to join
- Age > 18 years Mental competence Gestational age > 37-week Informed consent Diagnosis of preeclampsia (with or without features of severity)
Who cannot join
- Gestational age < 37-week Known bleeding or thrombotic diathesis Use of aspirin or unfractionated or low-molecular weight heparin within the last 48 hours BMI > 35 Maternal comorbid conditions other than preeclampsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Age on Reference Values for Thromboelastography in Pregnant Women With Pre-eclampsia
There are no studies evaluating the effect of aging on hemostasis of preeclamptic patients. Additionally, although there are some studies that establish normal reference values for TEG profiles in healthy term pregnant patients, conflicting results have been found in preeclampsia. Reference values are important to establish baseline parameters in cases of pre-eclampsia complicated by postpartum hemorrhage. The investigators will evaluate reference values for TEG in postdelivery preeclamptic patients and the difference between vaginal delivery and cesarean section.
Read the detailed description
After approval by the Institutional Review Board and informed consent from participants, the investigators are obtaining blood samples for TEG processing, from pregnant patients admitted to the maternity unit of Augusta University Medical Center. Patients are being classified in 2 groups: term pregnant patients with diagnosis of pre-eclampsia who undergo cesarean section and those having spontaneous vaginal delivery. Each group will be divided into subgroups according to maternal age: 18-25 years, 26-35 years, >36 years. Pre-eclampsia is defined and classified according to the definitions of the American College of Obstetricians and Gynecologists published in 2013.
- Conditions
- Preeclampsia, Coagulation Disorder, Pregnancy Complications
- Being tested
- Thromboelastogram
- Medical subject headings
- Pre-Eclampsia, Hemostatic Disorders, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastogramDiagnostic test
Blood sample processing for thromboelastogram
| Study group | Role | What they receive |
|---|---|---|
| Post-cesarean preeclampsia | Not described Receives: Diagnostic Test: Thromboelastogram | |
| Post spontaneous vaginal delivery preeclampsia | Not described Receives: Diagnostic Test: Thromboelastogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
R time
Reaction time of whole blood
Measured: 10 minutes
Secondary outcomes (3)
K time
Activation time
Measured: 10 minutes
Maximum amplitude
Amplitude in relation to platelet count and function
Measured: 10 minutes
LY-30
Lysis at 30 minutes
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start22 May 2018
- Primary completion31 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555630
- Sponsor's protocol ID
- [1167446
- Status last verified
- Mar 2020
- First submitted
- 1 Jun 2018
- Last updated
- 24 Mar 2020
- 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 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on Reference Values for Thromboelastography in Pregnant Women With Pre-eclampsia
- ClinicalTrials.gov ID
- NCT03555630
- Acronym / sponsor ID
- [1167446
- Conditions
- Preeclampsia, Coagulation Disorder, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Jun 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.
There are no studies evaluating the effect of aging on hemostasis of preeclamptic patients. Additionally, although there are some studies that establish normal reference values for TEG profiles in healthy term pregnant patients, conflicting results have been found in preeclampsia. Reference values are important to establish baseline parameters in cases of pre-eclampsia complicated by postpartum hemorrhage. The investigators will evaluate reference values for TEG in postdelivery preeclamptic patients and the difference between vaginal delivery and cesarean section.
Detailed description
After approval by the Institutional Review Board and informed consent from participants, the investigators are obtaining blood samples for TEG processing, from pregnant patients admitted to the maternity unit of Augusta University Medical Center. Patients are being classified in 2 groups: term pregnant patients with diagnosis of pre-eclampsia who undergo cesarean section and those having spontaneous vaginal delivery. Each group will be divided into subgroups according to maternal age: 18-25 years, 26-35 years, >36 years. Pre-eclampsia is defined and classified according to the definitions of the American College of Obstetricians and Gynecologists published in 2013.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-cesarean preeclampsia | – | Diagnostic Test: Thromboelastogram |
| Post spontaneous vaginal delivery preeclampsia | – | Diagnostic Test: Thromboelastogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Term pregnant patients with preeclampsia
Key inclusion criteria (1 listed)
- Age > 18 years Mental competence Gestational age > 37-week Informed consent Diagnosis of preeclampsia (with or without features of severity)
Key exclusion criteria (1 listed)
- Gestational age < 37-week Known bleeding or thrombotic diathesis Use of aspirin or unfractionated or low-molecular weight heparin within the last 48 hours BMI > 35 Maternal comorbid conditions other than preeclampsia
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 |
|---|---|---|
| ThromboelastogramBlood sample processing for thromboelastogram | Diagnostic test | Post spontaneous vaginal delivery preeclampsia, Post-cesarean preeclampsia |
Primary outcome
R time
Time frame: 10 minutes
Reaction time of whole blood
3 secondary outcomes
K time
Time frame: 10 minutes
Maximum amplitude
Time frame: 10 minutes
LY-30
Time frame: 30 minutes
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 24 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preeclampsia and Coagulation Disorder, run by Augusta University 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 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 24 Mar 2020. 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 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?
R time (time frame: 10 minutes). 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 24 Mar 2020.