Pre-EclampsiaNCT05098691
Early Onset Preeclampsia and Nectin-4
An observational study of Pre-Eclampsia and Early Onset Preeclampsia, run by Hatice Akkaya at 1 site in Turkey (Türkiye).
Trial summary
Early-onset Preeclampsia (PE) is a pregnancy disorder which may present with adverse pregnancy outcomes. Nectin-4 is an adhesion molecule mainly expressed in placenta. This study aimed to evaluate the relationship between early onset Preeclampsia and serum Nectin 4 levels. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pre-Eclampsia, Early Onset Preeclampsia, Oxidative Stress
- What is being tested?
- serum marker levels
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 30 Dec 2020
- 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
- No healthy volunteers
- Adult
Study population: Comparison to the level of soluble nectin-4 in early-onset PE, compared to healthy pregnancies
Who may be able to join
- spontaneous,
- singleton pregnancies
- above the 24 weeks of gestations
- positive fetal cardiac activity
Who cannot join
- multiple gestations,
- chronic hypertension
- hypothyroidism
- known malignancy,- diabetes mellitus,
- presence of fetal or maternal infection,
- clinical signs of chorioamnionitis (maternal fever, vaginal discharge, fetal tachycardia),
- hepatic or renal failure
- Placenta previa or pregnancies accompanied congenital fetal abnormalities or aneuploidies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Nectin-4 Levels in Patients With Early Onset Preeclampsia
Early-onset Preeclampsia (PE) is a pregnancy disorder which may present with adverse pregnancy outcomes. Nectin-4 is an adhesion molecule mainly expressed in placenta. This study aimed to evaluate the relationship between early onset Preeclampsia and serum Nectin 4 levels.
Read the detailed description
Preeclampsia is assumed as a two-stage disorder arising from defective trophoblast invasion and failure of spiral artery remodeling as the main step responsible for the pathogenesis. PE is classified according to the disease onset time as early-onset PE before 34 weeks and late-onset PE after 34 weeks. Late-onset PE is more commonly seen and accepted as a mild maternal reaction to pregnancy. In early-onset PE, unlike the late-onset, due to the improper placental invasion, the diffuse placental ischemia and the resulting oxidative stress begin at early gestation. Thus, the early-onset PE may result in severe disease leading to perinatal and maternal morbidity and mortality.
The nectins are calcium-independent immunoglobulin-like celladhesion molecules and have a pivotal role at cellular junctions, as well as physiological regulations(8). Placenta expressesfor types of nectins; nectin-1, nectin-2, nectin-3, and nectin-4. They are localized at tight junctions and gap junctions of syncitiotrophoblasts(9). Nectin-4 is a relatively novel member of nectin family which has been detected only in placenta and airway epithelium in healthy subjects.
Despite, there has been no study published yet to reveal the soluble nectin-4 levels in preeclampsia as well as in early onset disease. In this study, we aimed to investigate the serum nectin-4 levels in early-onset preeclampsia in comparison of the healthy pregnancies.
- Conditions
- Pre-Eclampsia, Early Onset Preeclampsia, Oxidative Stress, Immunologic Diseases in Pregnancy
- Being tested
- serum marker levels
- Keywords
- early onset preeclampsia, nectin-4, advers pregnancy outcome, hypertansion
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum marker levelsDiagnostic test
two groups comparisons
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Early onset Preeclampsia ) | 43 cases The groups were matched for gestational age and gravidity. Receives: Diagnostic Test: serum marker levels | |
| Group 2 ( Healthy pregnant woman) control group | 41 cases The groups were matched for gestational age and gravidity Receives: Diagnostic Test: serum marker levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum nectin-4 levels
ng/ml
Measured: 1 hour
Secondary outcomes (2)
BMI (body mass index)
kg/m2
Measured: 5 minute
Tansion Arterial
mm Hg
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 May 2020
- Primary completion15 Dec 2020
- Study completion30 Dec 2020
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Akkaya
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hatice Akkaya, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098691
- Sponsor's protocol ID
- KAEK/2020.05.13
- Status last verified
- Oct 2021
- First submitted
- 16 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If needed
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Nectin-4 Levels in Patients With Early Onset Preeclampsia
- ClinicalTrials.gov ID
- NCT05098691
- Acronym / sponsor ID
- KAEK/2020.05.13
- Conditions
- Pre-Eclampsia, Early Onset Preeclampsia, Oxidative Stress, Immunologic Diseases in Pregnancy
- Keywords
- early onset preeclampsia, nectin-4, advers pregnancy outcome, hypertansion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hatice AkkayaOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 28 Oct 2021 (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.
Early-onset Preeclampsia (PE) is a pregnancy disorder which may present with adverse pregnancy outcomes. Nectin-4 is an adhesion molecule mainly expressed in placenta. This study aimed to evaluate the relationship between early onset Preeclampsia and serum Nectin 4 levels.
Detailed description
Preeclampsia is assumed as a two-stage disorder arising from defective trophoblast invasion and failure of spiral artery remodeling as the main step responsible for the pathogenesis. PE is classified according to the disease onset time as early-onset PE before 34 weeks and late-onset PE after 34 weeks. Late-onset PE is more commonly seen and accepted as a mild maternal reaction to pregnancy. In early-onset PE, unlike the late-onset, due to the improper placental invasion, the diffuse placental ischemia and the resulting oxidative stress begin at early gestation. Thus, the early-onset PE may result in severe disease leading to perinatal and maternal morbidity and mortality.
The nectins are calcium-independent immunoglobulin-like celladhesion molecules and have a pivotal role at cellular junctions, as well as physiological regulations(8). Placenta expressesfor types of nectins; nectin-1, nectin-2, nectin-3, and nectin-4. They are localized at tight junctions and gap junctions of syncitiotrophoblasts(9). Nectin-4 is a relatively novel member of nectin family which has been detected only in placenta and airway epithelium in healthy subjects.
Despite, there has been no study published yet to reveal the soluble nectin-4 levels in preeclampsia as well as in early onset disease. In this study, we aimed to investigate the serum nectin-4 levels in early-onset preeclampsia in comparison of the healthy pregnancies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Early onset Preeclampsia ) | – | Diagnostic Test: serum marker levels43 cases The groups were matched for gestational age and gravidity. |
| Group 2 ( Healthy pregnant woman) control group | – | Diagnostic Test: serum marker levels41 cases The groups were matched for gestational age and gravidity |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Comparison to the level of soluble nectin-4 in early-onset PE, compared to healthy pregnancies
Key inclusion criteria (4 listed)
- spontaneous,
- singleton pregnancies
- above the 24 weeks of gestations
- positive fetal cardiac activity
Key exclusion criteria (8 listed)
- multiple gestations,
- chronic hypertension
- hypothyroidism
- known malignancy,- diabetes mellitus,
- presence of fetal or maternal infection,
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 |
|---|---|---|
| serum marker levelstwo groups comparisons | Diagnostic test | Group 1 (Early onset Preeclampsia ), Group 2 ( Healthy pregnant woman) control group |
Primary outcome
serum nectin-4 levels
Time frame: 1 hour
ng/ml
2 secondary outcomes
BMI (body mass index)
Time frame: 5 minute
Tansion Arterial
Time frame: 5 minute
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 28 Oct 2021.
- Individual participant dataSharing planned: Yes. If needed
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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 Pre-Eclampsia and Early Onset Preeclampsia, run by Hatice Akkaya 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 4 inclusion and 8 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 28 Oct 2021. 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 nectin-4 levels (time frame: 1 hour). 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 28 Oct 2021.