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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03171675
Other study ID # 22/01/2014; #33
Secondary ID
Status Completed
Phase N/A
First received May 28, 2017
Last updated July 20, 2017
Start date December 25, 2014
Est. completion date June 16, 2015

Study information

Verified date July 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid and placental tissue samples of pregnant females as a possible marker in determining whether or not an association exists between chronic periodontitis and preterm labor. Interleukin-17 is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal disease.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 16, 2015
Est. primary completion date March 2, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

1. Within the age range of 18-35 years

2. Free of any systemic diseases as referenced from Burket's Oral Medicine health history questionnaire (Glick2008)

3. Spontaneous normal term birth at =37 weeks of gestation without any obstetrical or medical complications

4. Spontaneous preterm birth (PTB) at <37 weeks of gestation after uterine contraction or rupture of membranes (Keelan1999)

Exclusion Criteria:

1. History of medications that may affect the study outcome, such as: current use of systemic corticosteroids or antibiotics for at least one month

2. Genital and urinary tract infections

3. Existing hypertension and diabetes mellitus before pregnancy, autoimmune disease, asthma, and chronic renal disease

4. Multiple pregnancies, cervical cerculage, abnormal placentation, past history of preterm delivery, or antepartum hemorrhage

5. Low or high maternal body mass index

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

References & Publications (3)

Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. Review. — View Citation

Glick M, Greenberg MS, Ship JA. Introduction to oral medicine and oral diagnosis: evaluation of the dental patient. In: Greenberg MS, Glick M, Ship JA. Burket's Oral Medicine. 11th Edition. Hamilton, Ontario: BC Decker; 2008:3.

Keelan JA, Marvin KW, Sato TA, Coleman M, McCowan LM, Mitchell MD. Cytokine abundance in placental tissues: evidence of inflammatory activation in gestational membranes with term and preterm parturition. Am J Obstet Gynecol. 1999 Dec;181(6):1530-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Interleukin-17 Interleukin-17 levels in gingival crevicular fluid and placental tissue samples Single sample from each patient following birth
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