PreeclampsiaNCT03932877
Serum Soluble Endoglin and Matrix Metalloproteinase 14 With Elisa Method in Early/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
Objective: Defective placentation and inadequate trophoblastic invasion have an important place in the aetiology of preeclampsia (PrE). Trophoblasts invade the maternal decidua and remodel spiral arteries with matrix metalloproteinase-14 (MMP-14). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- MMP-14 and s-ENG levels
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2018to 30 Dec 2018
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The investigators consecutively will recruite 61 subjects with preeclampsia, and 64 healthy preganancies will selecte for the control group. Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys. Preeclampsia usually begins after 20 weeks of pregnancy in women whose blood pressure had been normal. Early-onset preeclampsia is usually defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.
Who may be able to join
- preeclampsia
- healthy pregnancy
Who cannot join
- pregnant women with any systemic condition (such as chronic hypertension, diabetes mellitus, thyroid diseases, liver and kidney diseases)
- women with a history of drug use throughout pregnancy
- history of medication for PE treatment at the time of first admission
- patients who had fetal congenital abnormalities or genetic syndromes
- multiple gestations
- active labour
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cengiz Gokcek Women's and Child's hospital
Gaziantep
About this study
Official title: An Analysis Soluble Endoglin and Matrix Metalloproteinase 14 With Elisa Method in the Diagnosis and Severity of Early/Late-onset Preeclampsia
Objective: Defective placentation and inadequate trophoblastic invasion have an important place in the aetiology of preeclampsia (PrE). Trophoblasts invade the maternal decidua and remodel spiral arteries with matrix metalloproteinase-14 (MMP-14). To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished. This study aims to investigate the value of serum MMP-14 and soluble endoglin (s-ENG) in PrE patients and healthy controls.
Methods: The study was conducted with 30 late-onset preeclampsia patients (L-PrE) as group1 (gestational age≥34 weeks), 33 patients with normal pregnancies as group2 (gestational age≥34 weeks), 31 early-onset preeclampsia patients (E-PrE) as group3 (gestational age<34 weeks), and 31 patients with normal pregnancies as group 4 (gestational age<34 weeks). Serum MMP-14 and s-ENG levels measured by ELISA were compared.
Read the detailed description
The study was conducted at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey at department of obstetrics and gynecology between date of January 2018 and December 2018. The study protocol was designed according to the Declaration of Helsinki, and the institutional ethical review board of Gaziantep University approved the study (Reference number: 2018/91). One hundred twenty-five women enrolled in the study in four groups. The investigators consecutively recruited 61 pregnancies complicated with preeclampsia, and 64 healthy pregnancies will select for the control group. All participiants gave their oral and written informed consent before their inclusion in the study.
- Conditions
- Preeclampsia
- Being tested
- MMP-14 and s-ENG levels
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMP-14 and s-ENG levelsOther
Venous blood sampled from the antecubital veins for measuring the serum concentration of MMP-14 and s-ENG levels. The serum MMP-14 and s-ENG levels measured using commercially available reagent kits, which is produced to detect human MMP-14 and s-ENG levels (Rel Assay Diagnostics Gaziantep, Turkey). The MMP-14 and s-ENG levels measurements were performed in accordance with the company's protocol.
| Study group | Role | What they receive |
|---|---|---|
| late-onset preeclampsia, group1 | 30 late-onset preeclampsia patients as group1 (gestational age≥34 weeks). The diagnosis of preeclampsia, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will establish based on the presence of proteinuria (urinary excretion of 300 mg protein or higher, or at least 1+in dipstick in a 24-h urine specimen) and a blood pressure level of ≥140/90mmHg (two blood pressure measurements 6 h apart) that occurs after 20 weeks of gestation in a previously normotensive woman. Diastolic and/or systolic blood pressure up to 110/160 mm Hg will consider mild, and higher values will consider to being severe. Receives: Other: MMP-14 and s-ENG levels | |
| Control, group 2 | 33 patients with normal pregnancies as group2 (gestational age≥34 weeks). 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: MMP-14 and s-ENG levels | |
| early-onset preeclampsia, group 3 | 31 early-onset preeclampsia patients as group3 (gestational age<34 weeks). The diagnosis of preeclampsia, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will establish based on the presence of proteinuria (urinary excretion of 300 mg protein or higher, or at least 1+in dipstick in a 24-h urine specimen) and a blood pressure level of ≥140/90mmHg (two blood pressure measurements 6 h apart) that occurs after 20 weeks of gestation in a previously normotensive woman. Diastolic and/or systolic blood pressure up to 110/160 mm Hg considered mild, and higher values considered to being severe. Receives: Other: MMP-14 and s-ENG levels | |
| Control, group 4 | 31 patients with normal pregnancies as group 4 (gestational age<34 weeks). 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: MMP-14 and s-ENG levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum matrix metalloproteinase-14 levels in preeclampsia
The primary endpoint in this analysis is to evaluate the value of serum matrix metalloproteinase-14 levels (ng/ml) in preeclampsia patients and also address its relationship with its severity.
Measured: 1 day
Secondary outcomes (1)
Serum soluble endoglin levels in preeclampsia
The secondary endpoint in this analysis is to evaluate the value of serum soluble endoglin levels (ng/ml) in preeclampsia patients and also address its relationship with its severity.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start30 Jan 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
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
- 125 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, Principal investigator, Cengiz Gokcek WCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932877
- Sponsor's protocol ID
- CengizGWCH3
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang XH, Zhang HY, Lu S, Jiang LL, Wu J, Yang YL, Zhang SA. MMP-14 aggravates onset of severe preeclampsia by mediating soluble endoglin release. Eur Rev Med Pharmacol Sci. 2018 Mar;22(5):1209-1215. doi: 10.26355/eurrev_201803_14460.
PubMed 29565476Espino Y Sosa S, Flores-Pliego A, Espejel-Nunez A, Medina-Bastidas D, Vadillo-Ortega F, Zaga-Clavellina V, Estrada-Gutierrez G. New Insights into the Role of Matrix Metalloproteinases in Preeclampsia. Int J Mol Sci. 2017 Jul 20;18(7):1448. doi: 10.3390/ijms18071448.
PubMed 28726716Kaitu'u-Lino TJ, Palmer KR, Whitehead CL, Williams E, Lappas M, Tong S. MMP-14 is expressed in preeclamptic placentas and mediates release of soluble endoglin. Am J Pathol. 2012 Mar;180(3):888-894. doi: 10.1016/j.ajpath.2011.11.014. Epub 2012 Jan 31.
PubMed 22296769Ovayolu A, Karaman E, Turgut A, Cekici Y, Ortabag T, Chiara Rapisarda AM, Noventa M, Cianci A. Endothelial cell-specific-molecule-1 (endocan) levels in women with premature ovarian insufficiency: a prospective comparative study. J Obstet Gynaecol. 2021 May;41(4):637-641. doi: 10.1080/01443615.2020.1789952. Epub 2020 Aug 18.
PubMed 32808833
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis Soluble Endoglin and Matrix Metalloproteinase 14 With Elisa Method in the Diagnosis and Severity of Early/Late-onset Preeclampsia
- ClinicalTrials.gov ID
- NCT03932877
- Acronym / sponsor ID
- CengizGWCH3
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Cengiz Gokcek Women's and Children's HospitalUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 1 May 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.
Objective: Defective placentation and inadequate trophoblastic invasion have an important place in the aetiology of preeclampsia (PrE). Trophoblasts invade the maternal decidua and remodel spiral arteries with matrix metalloproteinase-14 (MMP-14). To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished. This study aims to investigate the value of serum MMP-14 and soluble endoglin (s-ENG) in PrE patients and healthy controls.
Methods: The study was conducted with 30 late-onset preeclampsia patients (L-PrE) as group1 (gestational age≥34 weeks), 33 patients with normal pregnancies as group2 (gestational age≥34 weeks), 31 early-onset preeclampsia patients (E-PrE) as group3 (gestational age<34 weeks), and 31 patients with normal pregnancies as group 4 (gestational age<34 weeks). Serum MMP-14 and s-ENG levels measured by ELISA were compared.
Detailed description
The study was conducted at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey at department of obstetrics and gynecology between date of January 2018 and December 2018. The study protocol was designed according to the Declaration of Helsinki, and the institutional ethical review board of Gaziantep University approved the study (Reference number: 2018/91). One hundred twenty-five women enrolled in the study in four groups. The investigators consecutively recruited 61 pregnancies complicated with preeclampsia, and 64 healthy pregnancies will select for the control group. All participiants 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
- 4
| Arm | Type | Receives |
|---|---|---|
| late-onset preeclampsia, group1 | – | Other: MMP-14 and s-ENG levels30 late-onset preeclampsia patients as group1 (gestational age≥34 weeks). The diagnosis of preeclampsia, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will establish based on the presence of proteinuria (urinary excretion of 300 mg protein or higher, or at least 1+in dipstick in a 24-h urine specimen) and a blood pressure level of ≥140/90mmHg (two blood pressure measurements 6 h apart) that occurs after 20 weeks of gestation in a previously normotensive woman. Diastolic and/or systolic blood pressure up to 110/160 mm Hg will consider mild, and higher values will consider to being severe. |
| Control, group 2 | – | Other: MMP-14 and s-ENG levels33 patients with normal pregnancies as group2 (gestational age≥34 weeks). 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. |
| early-onset preeclampsia, group 3 | – | Other: MMP-14 and s-ENG levels31 early-onset preeclampsia patients as group3 (gestational age<34 weeks). The diagnosis of preeclampsia, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will establish based on the presence of proteinuria (urinary excretion of 300 mg protein or higher, or at least 1+in dipstick in a 24-h urine specimen) and a blood pressure level of ≥140/90mmHg (two blood pressure measurements 6 h apart) that occurs after 20 weeks of gestation in a previously normotensive woman. Diastolic and/or systolic blood pressure up to 110/160 mm Hg considered mild, and higher values considered to being severe. |
| Control, group 4 | – | Other: MMP-14 and s-ENG levels31 patients with normal pregnancies as group 4 (gestational age<34 weeks). 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The investigators consecutively will recruite 61 subjects with preeclampsia, and 64 healthy preganancies will selecte for the control group. Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys. Preeclampsia usually begins after 20 weeks of pregnancy in women whose blood pressure had been normal. Early-onset preeclampsia is usually defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.
Key inclusion criteria (2 listed)
- preeclampsia
- healthy pregnancy
Key exclusion criteria (6 listed)
- pregnant women with any systemic condition (such as chronic hypertension, diabetes mellitus, thyroid diseases, liver and kidney diseases)
- women with a history of drug use throughout pregnancy
- history of medication for PE treatment at the time of first admission
- patients who had fetal congenital abnormalities or genetic syndromes
- multiple gestations
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 |
|---|---|---|
| MMP-14 and s-ENG levelsVenous blood sampled from the antecubital veins for measuring the serum concentration of MMP-14 and s-ENG levels. The serum MMP-14 and s-ENG levels measured using commercially available reagent kits, which is produced to detect human MMP-14 and s-ENG levels (Rel Assay Diagnostics Gaziantep, Turkey). The MMP-14 and s-ENG levels measurements were performed in accordance with the company's protocol. | Other | Control, group 2, Control, group 4, early-onset preeclampsia, group 3, late-onset preeclampsia, group1 |
Primary outcome
Serum matrix metalloproteinase-14 levels in preeclampsia
Time frame: 1 day
The primary endpoint in this analysis is to evaluate the value of serum matrix metalloproteinase-14 levels (ng/ml) in preeclampsia patients and also address its relationship with its severity.
1 secondary outcome
Serum soluble endoglin levels in preeclampsia
Time frame: 1 day
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 2 May 2019.
- Results publication: PubMed 29565476Zhang XH, Zhang HY, Lu S, Jiang LL, Wu J, Yang YL, Zhang SA. MMP-14 aggravates onset of severe preeclampsia by mediating soluble endoglin release. Eur Rev Med Pharmacol Sci. 2018 Mar;22(5):1209-1215. doi: 10.26355/eurrev_201803_14460.
- Results publication: PubMed 28726716Espino Y Sosa S, Flores-Pliego A, Espejel-Nunez A, Medina-Bastidas D, Vadillo-Ortega F, Zaga-Clavellina V, Estrada-Gutierrez G. New Insights into the Role of Matrix Metalloproteinases in Preeclampsia. Int J Mol Sci. 2017 Jul 20;18(7):1448. doi: 10.3390/ijms18071448.
- Results publication: PubMed 22296769Kaitu'u-Lino TJ, Palmer KR, Whitehead CL, Williams E, Lappas M, Tong S. MMP-14 is expressed in preeclamptic placentas and mediates release of soluble endoglin. Am J Pathol. 2012 Mar;180(3):888-894. doi: 10.1016/j.ajpath.2011.11.014. Epub 2012 Jan 31.
- Derived from this study: PubMed 32808833Ovayolu A, Karaman E, Turgut A, Cekici Y, Ortabag T, Chiara Rapisarda AM, Noventa M, Cianci A. Endothelial cell-specific-molecule-1 (endocan) levels in women with premature ovarian insufficiency: a prospective comparative study. J Obstet Gynaecol. 2021 May;41(4):637-641. doi: 10.1080/01443615.2020.1789952. Epub 2020 Aug 18.
- Individual participant dataSharing planned: Undecided
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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.
Ali Ovayolu 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 2 inclusion and 6 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 2 May 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?
Serum matrix metalloproteinase-14 levels in preeclampsia (time frame: 1 day). 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 NCT03932877, 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 2 May 2019.