ClinicalTrials.gg
CompletedNCT01652300Updated Jul 30, 2012

The Effect of Oral Health Education in Pregnancy

A Phase 2/3 interventional study of two educational sessions and no education in Pregnancy, sponsored by Gonabad University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-30.

Sponsored by Gonabad University of Medical Sciences · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

In this 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.

02

Conditions studied

  • Pregnancy

Browse trials for

Keywords

  • Oral health
  • education
  • knowledge
  • attitude
  • performance
03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's enrollment of 142 is above the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

Gonabad University of Medical Sciences is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • who did not attend the education sessions
  • failed to complete the questionnaires
  • receive any special education between post-test and stability test
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    test group

    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

  • Other
    control

    received no education

    Behavioral: no education

Interventions

  • Behavioraltwo educational sessions

    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

  • Behavioralno education

    women in the control group received no education

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

06

What researchers measure

Primary outcomes

  1. Score of KAP about oral health

    Time frame: 2 months

07

Study locations

1 site
  • Mums
    Mashhad, Khorasan Razavi, Iran, Islamic Republic of
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01652300
Lead sponsor
Gonabad University of Medical Sciences
Collaborators
Mashhad University of Medical Sciences
Responsible party
NarjesBahriBinabaj (Instructor in midwifery education, Gonabad University of Medical Sciences) — Principal investigator
First posted
Jul 30, 2012
Start date
Jun 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jul 30, 2012

Study contacts

narjes BahriBinabaj, Msc
principal investigator · GonabadMUM

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion