ClinicalTrials.gg
CompletedNCT05098691Updated Oct 28, 2021

Early Onset Preeclampsia and Nectin-4

An observational study in Pre-Eclampsia, Early Onset Preeclampsia and Oxidative Stress, sponsored by Hatice Akkaya. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by Hatice Akkaya · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
84
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 50 studies in Pre-Eclampsia with a site in Turkey — 11 open to participants now, 11 under way, none of them phase 3. Pre-Eclampsia · Turkey.

Enrollment
22nd of 31
84 · median 96
Started
2020
with 5 others
Observational
31 of 50
6 open now
Registered
23rd of 50
by date

Among the 50 studies in Pre-Eclampsia with a site in Turkey, this one is the 22nd largest by enrollment of the 31 observational ones that give a count, is one of 6 that started in 2020, is one of 31 observational ones, and was the 23rd registered.

Pre-Eclampsia

917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.

Browse Pre-Eclampsia studies →

Open to participants now

11 of the 50 studies in Pre-Eclampsia with a site in Turkey are open now. Recruiting first, the newest first:

6 more — sign in →

All 11 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.

This study: 18 Years to 40 Years · female · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Pre-Eclampsia
  • Early Onset Preeclampsia
  • Oxidative Stress
  • Immunologic Diseases in Pregnancy

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Keywords

  • early onset preeclampsia
  • nectin-4
  • advers pregnancy outcome
  • hypertansion
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Comparison to the level of soluble nectin-4 in early-onset PE, compared to healthy pregnancies

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • spontaneous,
  • singleton pregnancies
  • above the 24 weeks of gestations
  • positive fetal cardiac activity

Exclusion criteria

Exclusion Criteria:

  • multiple gestations,
  • chronic hypertension
  • hypothyroidism
  • known ,- 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
84 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1 (Early onset Preeclampsia )

    43 cases The groups were matched for gestational age and gravidity.

    Diagnostic Test: serum marker levels

  • Group 2 ( Healthy pregnant woman) control group

    41 cases The groups were matched for gestational age and gravidity

    Diagnostic Test: serum marker levels

Interventions

  • Diagnostic testserum marker levels

    two groups comparisons

06

What researchers measure

Primary outcomes

  1. serum nectin-4 levels

    ng/ml

    Time frame: 1 hour

Secondary outcomes

  1. BMI (body mass index)

    kg/m2

    Time frame: 5 minute

  2. Tansion Arterial

    mm Hg

    Time frame: 5 minute

07

Study locations

1 site
  • Hatice Akkaya
    İstanbul, 34010, Turkey
08

References and documents

Individual participant data

Plan to share: Yes — If needed

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 1 year

Access criteria: journals editors request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2020 to primary completion in Dec 2020, 7 months.

Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 7 months is below that.

Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2021
First posted
Oct 28, 2021
StartActual
May 1, 2020
Primary completionActual
Dec 15, 2020
CompletionActual
Dec 30, 2020
Last update
Oct 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05098691
Lead sponsor
Hatice Akkaya
Responsible party
Hatice Akkaya (associate professor, Kayseri Education and Research Hospital) — Sponsor-investigator
First posted
Oct 28, 2021
Start date
May 1, 2020
Primary completion
Dec 15, 2020
Completion
Dec 30, 2020
Last update
Oct 28, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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