NCT01652300

Brief Summary

Periodontal diseased during pregnancy are associated with many unpleasant prenatal consequences including preeclampsia, preterm labor, and low birth weight (LBW). Treatment of such diseases and observance of oral and dental hygiene may to some large extent prevent such consequences. Unfortunately previous studies have shown that pregnant women have very little knowledge of oral and dental health implications. Given the fact that pregnancy my be a unique opportunity to initiate correct hygienic behaviors in young women, this paper has focused on studying the effects of oral and dental health education during pregnancy. In this single blind clinical trial study,140 pregnant women receiving care from Khaje Rabi Regional Health Center in Mashhad city who were members of a community based multi-center were chosen by systematic clustering methods and randomly allocated into test and control groups. After intervention, two questionnaires were completed for demographic and pregnancy details of the participants. Knowledge, health belief and health behavior were assessed before intervention. The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy. women in the control group received no education. Knowledge, health belief and health behavior were assessed immediately after and one month after intervention of all participants. Analysis of data was done using SPSS, t-test and chi-square tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for phase_2 pregnancy

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

July 17, 2012

Last Update Submit

July 27, 2012

Conditions

Pregnancy

Keywords

Oral healtheducationknowledgeattitudeperformance

Outcome Measures

Primary Outcomes (1)

  • Score of KAP about oral health

    2 months

Study Arms (2)

test group

EXPERIMENTAL

For test group intervention was two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy

Behavioral: two educational sessions

control

OTHER

received no education

Behavioral: no education

Interventions

two educational sessionsBEHAVIORAL

The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy

Also known as: two educational sessions lasting 1 hour
test group
no educationBEHAVIORAL

women in the control group received no education

Also known as: women in the control group received no education
control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Spoke Persian
  • minimum education margin of primary school studies
  • Gestational age between 12 and 32 weeks
  • lacked any type of physical or mental problem
  • lacked of any disease that could prevent from taking dental care

You may not qualify if:

  • who did not attend the education sessions
  • failed to complete the questionnaires
  • receive any special education between post-test and stability test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mums

Mashhad, Khorasan Razavi, Iran

Location

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • narjes BahriBinabaj, Msc

    GonabadMUM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in midwifery education

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 30, 2012

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

IR(1)