Prevention of Pre-Term Birth by Treatment of Periodontal Disease

NCT00133926 | Unknown Phase 2 DMC

• 2 other identifiers: 353577NHMRC Australia 353577
• Study Type: interventional
• Target: 1,094
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate, in an Australian population of pregnant women, whether the treatment of periodontal disease during pregnancy prevents pre-term birth and other complications of pregnancy. Dental screening and periodontal treatment protocols have been based on standard techniques employed by hygienists that can be readily applied to the general obstetric population.

Conditions

Periodontal Diseases; Premature Birth; Pre-Eclampsia

Keywords

Periodontal disease; Pregnancy; Pre-term birth; Fetal growth; Pre-eclampsia; Infant, Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• Rate of pre-term birth

Secondary Outcomes (3)

• Rate of fetal growth restriction

• Rate of pre-eclampsia

• Rate of complications of pre-term birth

Interventions

Treatment of periodontal disease PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women, with single pregnancies, between 12 and 20 weeks gestation
• Periodontal disease defined as periodontal pocketing at a threshold of 4mm or more at 10% or more of sites
• Agree to receive periodontal treatment

You may not qualify if:

• Unable to attend for treatment
• Less than 16 years of age
• Have a fetus with an abnormality that predisposes the pregnancy to pre-term birth
• Multiple pregnancy
• Cardiac disease that would require antibiotic therapy
• Have fewer than 20 teeth
• Present for antenatal care after 20 weeks gestation
• Unable to understand the implications of participation in the trial
• Currently receiving periodontal treatment

Sponsors & Collaborators

• King Edward Memorial Hospital: lead
• The University of Western Australia: collaborator

Study Sites (1)

King Edward Memorial Hospital, Bagot Rd, Subiaco

Perth, Western Australia, 6008, Australia

RECRUITING

Related Publications (1)

• Newnham JP, Newnham IA, Ball CM, Wright M, Pennell CE, Swain J, Doherty DA. Treatment of periodontal disease during pregnancy: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1239-1248. doi: 10.1097/AOG.0b013e3181c15b40.

  PMID: 19935025 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Premature Birth; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Study Officials

• John P Newnham, MD, FRANZCOG

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John P Newnham, MD, FRANZCOG

CONTACT

61 9 9340 1331; jnewnham@obsgyn.uwa.edu.au

Dorota Doherty, PhD

CONTACT

61 9 9340 2222; ddoherty@obsgyn.uwa.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 24, 2005
• Study Start: March 1, 2005
• Study Completion: June 1, 2008
• Last Updated: April 5, 2007

Record last verified: 2007-04

Locations

AU (1)