PregnancyPhase 2/3NCT01652300
The Effect of Oral Health Education in Pregnancy
A Phase 2/3 study testing two educational sessions and no education in people with Pregnancy, run by Gonabad University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- two educational sessions and no education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteIran
- Study dates
- Jun 2008to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- who did not attend the education sessions
- failed to complete the questionnaires
- receive any special education between post-test and stability test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Education in Pregnancy Promotes Knowledge,Attitude and Performance of Pregnant Women About Oral Health.
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.
- Conditions
- Pregnancy
- Being tested
- two educational sessions, no education
- Keywords
- Oral health, education, knowledge, attitude, performance
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two educational sessionsBehavioural
Also called two educational sessions lasting 1 hour
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
no educationBehavioural
Also called women in the control group received no education
women in the control group received no education
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: two educational sessions |
| control | Other | received no education Receives: Behavioral: no education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of KAP about oral health
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonabad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Responsible party
- Principal investigator, NarjesBahriBinabaj, Gonabad University of Medical Sciences
- Investigators
- narjes BahriBinabaj, Msc, Principal investigator, GonabadMUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652300
- Sponsor's protocol ID
- MUMS
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Education in Pregnancy Promotes Knowledge,Attitude and Performance of Pregnant Women About Oral Health.
- ClinicalTrials.gov ID
- NCT01652300
- Acronym / sponsor ID
- MUMS
- Conditions
- Pregnancy
- Keywords
- Oral health, education, knowledge, attitude, performance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Gonabad University of Medical SciencesUniversity, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Behavioral: two educational sessionsFor 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 |
| control | Other | Behavioral: no educationreceived no education |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- who did not attend the education sessions
- failed to complete the questionnaires
- receive any special education between post-test and stability test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two educational sessionsAlso: two educational sessions lasting 1 hourThe test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy | Behavioural | test group |
| no educationAlso: women in the control group received no educationwomen in the control group received no education | Behavioural | control |
Primary outcome
Score of KAP about oral health
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- "Click here for more information about this study:"The Effect of Oral Health Education in Pregnancy"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
narjes BahriBinabaj, Msc principal investigator
GonabadMUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing two educational sessions and no education in people with Pregnancy, run by Gonabad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of KAP about oral health (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.