Pre-EclampsiaNCT05924061
The Role of Pentraxin 3 and Cathepsin B Levels in Preeclamptic Pregnancy
An observational study of Pre-Eclampsia and Cathepsin B Level, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigator aim was to compare Cathepsin B and Pentraxin 3 levels measured from maternal serum of pregnant women diagnosed with preeclampsia in the second trimester, the effects of these levels on maternal/ fetal outcomes and the composite results of Cathepsin B and Pentraxin 3 levels alone or… 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
- Pre-Eclampsia, Cathepsin B Level, Pentraxin 3 Level
- What is being tested?
- Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Dec 2022
- How long will I take part?
- 1 Year
- 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: singleton pregnancy white people socio-cultural differences were not considered
Who may be able to join
- Singleton pregnancy
- Pregnant women diagnosed with preeclampsia between 20-28 weeks of gestation
- Healthy pregnant women between 20-28 weeks of gestation who want to be involved in the study.
Who cannot join
- Multiple pregnancies
- Pregnant women who gave birth below 24 weeks of gestation
- Pregnant women diagnosed with other hypertensive diseases of pregnancy other than preeclampsia ( gestational hypertension, chronic hypertension, superimposed hypertension)
- Pregnant women with chromosomal or congenital anomalies in the fetus
- Women with a known infective or autoimmune disease before pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Pentraxin 3 and Cathepsin B Levels in the Second Trimester in Predicting of Maternal and Fetal Results in Preeclamptic Pregnancy
In this study, the investigator aim was to compare Cathepsin B and Pentraxin 3 levels measured from maternal serum of pregnant women diagnosed with preeclampsia in the second trimester, the effects of these levels on maternal/ fetal outcomes and the composite results of Cathepsin B and Pentraxin 3 levels alone or together and contribute to the literature in this area.
Read the detailed description
This prospective case-control study was conducted between 1 January 2022 and 31 December 2022 at Bursa Yuksek Ihtisas Training and Research Hospital. The study was conducted with pregnant women between ages of 18-45 who were diagnosed with preeclampsia in the second trimester. This study was conducted with total 156 pregnant women. participants were grouped according to the presence of preeclampsia; Group1: Patients diagnosed with preeclampsia between 20-28 weeks (study group) (n:78) , Group 2: Healthy pregnant women between 20-28 weeks without a diagnosis of preeclampsia ( control group) (n:78) . As soon as preeclampsia is diagnosed and before any treatment was started, maternal serum samples were collected in the Cathepsin B and Pentraxin 3 kit in amounts suitable for the study. The samples obtained were kept in biochemistry laboratory at -80 degrees until the study was conducted. After all samples were collected, Cathepsin B and Pentraxin 3 values were measured by ELISA method.
- Conditions
- Pre-Eclampsia, Cathepsin B Level, Pentraxin 3 Level
- Being tested
- Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women
- Keywords
- second trimester, preeclampsia, pentraxin 3, Cathepsin B
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant womenOther
The effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with preeclampsia between 20-28 weeks (study group) | Maternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks pregnant women with preeclampsia Receives: Other: Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women | |
| Healthy pregnant women between 20-28 weeks ( control group) | Maternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks healthy pregnant women ( control group) Receives: Other: Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effects and composite results of cathepsin b and pentraxin 3 levels in pregnant women diagnosed with preeclampsia
serum cathepsin b (nmoL pNA/mL) and serum pentraxin 3 (ng/ml) levels composite results on pregnant women diagnosed with preeclampsia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924061
- Sponsor's protocol ID
- 2011-KAEK-25 2021/09-09
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pentraxin 3 and Cathepsin B Levels in the Second Trimester in Predicting of Maternal and Fetal Results in Preeclamptic Pregnancy
- ClinicalTrials.gov ID
- NCT05924061
- Acronym / sponsor ID
- 2011-KAEK-25 2021/09-09
- Conditions
- Pre-Eclampsia, Cathepsin B Level, Pentraxin 3 Level
- Keywords
- second trimester, preeclampsia, pentraxin 3, Cathepsin B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Jun 2023 (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.
In this study, the investigator aim was to compare Cathepsin B and Pentraxin 3 levels measured from maternal serum of pregnant women diagnosed with preeclampsia in the second trimester, the effects of these levels on maternal/ fetal outcomes and the composite results of Cathepsin B and Pentraxin 3 levels alone or together and contribute to the literature in this area.
Detailed description
This prospective case-control study was conducted between 1 January 2022 and 31 December 2022 at Bursa Yuksek Ihtisas Training and Research Hospital. The study was conducted with pregnant women between ages of 18-45 who were diagnosed with preeclampsia in the second trimester. This study was conducted with total 156 pregnant women. participants were grouped according to the presence of preeclampsia; Group1: Patients diagnosed with preeclampsia between 20-28 weeks (study group) (n:78) , Group 2: Healthy pregnant women between 20-28 weeks without a diagnosis of preeclampsia ( control group) (n:78) . As soon as preeclampsia is diagnosed and before any treatment was started, maternal serum samples were collected in the Cathepsin B and Pentraxin 3 kit in amounts suitable for the study. The samples obtained were kept in biochemistry laboratory at -80 degrees until the study was conducted. After all samples were collected, Cathepsin B and Pentraxin 3 values were measured by ELISA method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with preeclampsia between 20-28 weeks (study group) | – | Other: Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant womenMaternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks pregnant women with preeclampsia |
| Healthy pregnant women between 20-28 weeks ( control group) | – | Other: Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant womenMaternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks healthy pregnant women ( control group) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- singleton pregnancy white people socio-cultural differences were not considered
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Pregnant women diagnosed with preeclampsia between 20-28 weeks of gestation
- Healthy pregnant women between 20-28 weeks of gestation who want to be involved in the study.
Key exclusion criteria (5 listed)
- Multiple pregnancies
- Pregnant women who gave birth below 24 weeks of gestation
- Pregnant women diagnosed with other hypertensive diseases of pregnancy other than preeclampsia ( gestational hypertension, chronic hypertension, superimposed hypertension)
- Pregnant women with chromosomal or congenital anomalies in the fetus
- Women with a known infective or autoimmune disease before pregnancy
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 |
|---|---|---|
| Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant womenThe effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia | Other | Healthy pregnant women between 20-28 weeks ( control group), Pregnant women with preeclampsia between 20-28 weeks (study group) |
Primary outcome
Comparison of the effects and composite results of cathepsin b and pentraxin 3 levels in pregnant women diagnosed with preeclampsia
Time frame: 12 months
serum cathepsin b (nmoL pNA/mL) and serum pentraxin 3 (ng/ml) levels composite results on pregnant women diagnosed with preeclampsia
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 29 Jun 2023.
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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 Pre-Eclampsia and Cathepsin B Level, run by Sanliurfa Mehmet Akif Inan Education and Research 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 3 inclusion and 5 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 29 Jun 2023. 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?
Comparison of the effects and composite results of cathepsin b and pentraxin 3 levels in pregnant women diagnosed with preeclampsia (time frame: 12 months). 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 29 Jun 2023.