PreeclampsiaPresepsin&PENCT04126902
Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia
An observational study of Preeclampsia, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is split out from the phagocytes membranes after phagocytosis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- interleukin-6, presepsin and pentraxin-3
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2018to 30 Sep 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The investigators consecutively recruited 50 subjects with preeclampsia, and 50 healthy pregnancies selected for the control group.
Who may be able to join
- preeclampsia healthy pregnancy
Who cannot join
- pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases),
- using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin),
- pregnant women who had fever at the time of the first admission,
- concurrent infections (urinary tract infection, cervicitis, etc.),
- pregnancies complicated with premature membrane rupture or chorioamnionitis,
- history of medication for PE treatment at the time of the first admission,
Show all 10Show fewer
- patients who had fetal congenital abnormalities or genetic syndromes,
- drug user,
- multiple gestations,
- active labor.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cengiz Gokcek Women's and Child's hospital
Gaziantep, 27010
About this study
Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is split out from the phagocytes membranes after phagocytosis. To investigators knowledge, this is the first study in literature to investigate maternal blood concentrations of presepsin in preeclampsia and healthy pregnant women.
Methods: The investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3 concentrations in pregnant women with (n=44) and without L-PrE (n=44). These three inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were compared.
Read the detailed description
This observational case-control study was designed at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey, in the Department of Obstetrics and Gynecology between June 2018 and January 2019. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2018/393). The study strictly adhered to the principles of the Declaration of Helsinki. All subjects included in the study gave oral and written informed consent. Eighty-eight women were enrolled in the study in two groups. All participants will gave their oral and written informed consent before their inclusion in the study.
- Conditions
- Preeclampsia
- Being tested
- interleukin-6, presepsin and pentraxin-3
- Keywords
- innate immunity, macrophage, toll-like receptors, trophoblasts, phagocytos
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin-6, presepsin and pentraxin-3Other
measurements and compare
| Study group | Role | What they receive |
|---|---|---|
| late-onset preeclampsia | The diagnosis of L-PrE, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), is established based on the presence of proteinuria (urinary excretion of protein ≥300 mg in a 24-h urine specimen, or proteinüria ≥1+ in dipstick) and a blood pressure level of ≥90/140 mmHg (two blood pressure measurements 6 h apart) that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure <110/160 mm Hg, it was accepted as mild; and in case these values exceeded this level, it was accepted as severe. The study population consisted of 50 late-onset preeclampsia patients as study group and 50 patients with normal pregnancies as control group. Receives: Other: interleukin-6, presepsin and pentraxin-3 | |
| Control | The control groups' samples obtained during the routine obstetrical care examination in the third trimester of pregnancy. Then these pregnant women followed-up until the delivery. Receives: Other: interleukin-6, presepsin and pentraxin-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group.
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia and control group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start6 Jun 2018
- Primary completion30 Jan 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cengiz Gokcek Women's and Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital
- Investigators
- Ali Ovayolu, MD, Principal investigator, Cengiz Gokcek WCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126902
- Sponsor's protocol ID
- CengizGWCH5
- Acronym
- Presepsin&PE
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy (HDP) Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Apr;4(2):105-45. doi: 10.1016/j.preghy.2014.01.003. Epub 2014 Feb 25.
PubMed 26104418Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027Canzoneri BJ, Lewis DF, Groome L, Wang Y. Increased neutrophil numbers account for leukocytosis in women with preeclampsia. Am J Perinatol. 2009 Nov;26(10):729-32. doi: 10.1055/s-0029-1223285. Epub 2009 May 18.
PubMed 19452432Pugni L, Pietrasanta C, Milani S, Vener C, Ronchi A, Falbo M, Arghittu M, Mosca F. Presepsin (Soluble CD14 Subtype): Reference Ranges of a New Sepsis Marker in Term and Preterm Neonates. PLoS One. 2015 Dec 31;10(12):e0146020. doi: 10.1371/journal.pone.0146020. eCollection 2015.
PubMed 26720209
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia
- ClinicalTrials.gov ID
- NCT04126902
- Acronym / sponsor ID
- Presepsin&PE / CengizGWCH5
- Conditions
- Preeclampsia
- Keywords
- innate immunity, macrophage, toll-like receptors, trophoblasts, phagocytos
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cengiz Gokcek Women's and Children's HospitalUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 15 Oct 2019 (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.
Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is split out from the phagocytes membranes after phagocytosis. To investigators knowledge, this is the first study in literature to investigate maternal blood concentrations of presepsin in preeclampsia and healthy pregnant women.
Methods: The investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3 concentrations in pregnant women with (n=44) and without L-PrE (n=44). These three inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were compared.
Detailed description
This observational case-control study was designed at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey, in the Department of Obstetrics and Gynecology between June 2018 and January 2019. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2018/393). The study strictly adhered to the principles of the Declaration of Helsinki. All subjects included in the study gave oral and written informed consent. Eighty-eight women were enrolled in the study in two groups. All participants will gave their oral and written informed consent before their inclusion in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| late-onset preeclampsia | – | Other: interleukin-6, presepsin and pentraxin-3The diagnosis of L-PrE, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), is established based on the presence of proteinuria (urinary excretion of protein ≥300 mg in a 24-h urine specimen, or proteinüria ≥1+ in dipstick) and a blood pressure level of ≥90/140 mmHg (two blood pressure measurements 6 h apart) that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure <110/160 mm Hg, it was accepted as mild; and in case these values exceeded this level, it was accepted as severe. The study population consisted of 50 late-onset preeclampsia patients as study group and 50 patients with normal pregnancies as control group. |
| Control | – | Other: interleukin-6, presepsin and pentraxin-3The control groups' samples obtained during the routine obstetrical care examination in the third trimester of pregnancy. Then these pregnant women followed-up until the delivery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The investigators consecutively recruited 50 subjects with preeclampsia, and 50 healthy pregnancies selected for the control group.
Key inclusion criteria (1 listed)
- preeclampsia healthy pregnancy
Key exclusion criteria (10 listed)
- pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases),
- using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin),
- pregnant women who had fever at the time of the first admission,
- concurrent infections (urinary tract infection, cervicitis, etc.),
- pregnancies complicated with premature membrane rupture or chorioamnionitis,
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 |
|---|---|---|
| interleukin-6, presepsin and pentraxin-3measurements and compare | Other | Control, late-onset preeclampsia |
Primary outcome
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group.
Time frame: 3 months
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia and control group.
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 15 Oct 2019.
- Background: PubMed 26104418Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy (HDP) Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Apr;4(2):105-45. doi: 10.1016/j.preghy.2014.01.003. Epub 2014 Feb 25.
- Background: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Results publication: PubMed 19452432Canzoneri BJ, Lewis DF, Groome L, Wang Y. Increased neutrophil numbers account for leukocytosis in women with preeclampsia. Am J Perinatol. 2009 Nov;26(10):729-32. doi: 10.1055/s-0029-1223285. Epub 2009 May 18.
- Results publication: PubMed 26720209Pugni L, Pietrasanta C, Milani S, Vener C, Ronchi A, Falbo M, Arghittu M, Mosca F. Presepsin (Soluble CD14 Subtype): Reference Ranges of a New Sepsis Marker in Term and Preterm Neonates. PLoS One. 2015 Dec 31;10(12):e0146020. doi: 10.1371/journal.pone.0146020. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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Preeclampsia (PE)
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.
Ali Ovayolu, MD principal investigator
Cengiz Gokcek WCH
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, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
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 10 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 15 Oct 2019. 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 Turkey (Türkiye). 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?
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126902, which also lists 4 linked publications.
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 15 Oct 2019.