NCT03088228

Brief Summary

Background: The purpose of this study is to examine the relationship between maternal preeclampsia and periodontal parameters and the correlation of these two disorders with maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and interleukin-6. The investigators also investigated their relation to the severity of preeclampsia. Methods: 82 preeclamptic women were recruited to the study (29 healthy pregnant women, 30 mild preeclamptic patient, 23 severe preeclamptic patient ). The clinical periodontal parameters and GCF samples were collected in the first day of puerperium.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

February 16, 2017

Last Update Submit

September 26, 2017

Conditions

PreeclampsiaPeriodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • maternal periodontal clinical parameters and IL-37 and IL-35 and IL-6 levels

    IL-37 IL-35 and IL-6 levels in maternal gingival crevicular fluid levels between the three groups

    6 months

Study Arms (3)

healthy pregnants

Diagnostic Test: gingival crevicular fluid collection

mild preeclampsia

severe preeclampsia

Interventions

gingival crevicular fluid collectionDIAGNOSTIC_TEST
healthy pregnants

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

23 severe preeclamptic patient, 30 mild preeclamptic patient and 29 healthy pregnant women were recruited to this study.

You may qualify if:

  • Aged between 18 and 45 years
  • and 40 weeks of gestation.
  • Healthy pregnants, mild and severe preeclampsia

You may not qualify if:

  • Patients with accompanying diseases
  • multiple gestations
  • congenital abnormalities were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

gingival crevicular flud was analyzed

MeSH Terms

Conditions

Pre-EclampsiaPeriodontal Diseases

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 16, 2017

First Posted

March 23, 2017

Study Start

February 2, 2015

Primary Completion

August 15, 2016

Study Completion

December 31, 2016

Last Updated

September 28, 2017

Record last verified: 2017-09