Correlation Between Inflammatory Markers in Gingival Crevicular Fluid, Serum and Amniotic Fluids in Periodontal Pregnant Women

NCT02022865 | Unknown

• 1 other identifier: HMO-12-0412
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main causes of adverse pregnancy outcome(s) are reported to be maternal infection and placental, foetal, or uterine pathosis. Maternal infection and placental pathosis appear to be the most important causal factors, possibly causing pre-term labour, premature pre-term membrane rupture, or result in medically induced pregnancy interruption. There are reports of a link between poor maternal periodontal health and composite adverse pregnancy outcome of pre-term low birth weight (PLBW). however, the reason for such correlation is still not clear. In the current study the investigators will try to follow a possible path between periodontal infection and uterus physiology, by signaling out inflammatory markers that may leak from the gingival fluid into the serum and from there to the amniotic fluid. the investigators will collect GCF, serum and amniotic fluid from patients undergoing elective amniocentesis and analyse inflammatory markers in the collected samples.

Conditions

Periodontal Disease; Adverse Pregnancy Outcome

Keywords

periodontitis; cytokines; adverse pregnancy outcome

Outcome Measures

Primary Outcomes (1)

• cytokines levels

  Using ELISA we will quantify the levels of inflammatory markers such as IL-6, TNFα and IL-1β.

  analysed at the end of sample collection. participants will be followed for the duration of pregnancy, an expected average of 5 months

Secondary Outcomes (1)

• presence of endotoxin and perio-pathogens DNA in the serum and amnionic fluid

  analysed at the end of sample collection. participants will be followed for the duration of pregnancy, an expected average of 5 months

Study Arms (2)

periodontitis patients

according to american academy of periodontology classification of periodontal diagnosis.

healthy periodontium

according to american academy of periodontology classification of periodontal diagnosis.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy pregnant women, undergoing elective amniocentesis

You may qualify if:

• age 18-45
• single fetus pregnancy
• at least 20 teeth present

You may not qualify if:

• high risk pregnancy
• alcohol consumption
• smoking
• pregnancy diabetes

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (2)

• Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.

  PMID: 18177778 BACKGROUND

• Offenbacher S, Jared HL, O'Reilly PG, Wells SR, Salvi GE, Lawrence HP, Socransky SS, Beck JD. Potential pathogenic mechanisms of periodontitis associated pregnancy complications. Ann Periodontol. 1998 Jul;3(1):233-50. doi: 10.1902/annals.1998.3.1.233.

  PMID: 9722707 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

gingival crevicular fluid, serum, aminiotic fluid

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior physician

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 30, 2013

Record last verified: 2013-12