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Trial registered on ANZCTR


Registration number
ACTRN12612001271897
Ethics application status
Approved
Date submitted
29/11/2012
Date registered
6/12/2012
Date last updated
11/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving maternal and infant outcomes: A multicentre randomised controlled trial of midwifery and dental intervention
Scientific title
In pregnant women how effective is a midwifery intervention (involving oral health education, assessment and referrals to dental clinics) and dental intervention compared with no intervention in improving women’s oral health status, uptake of dental services, oral health knowledge, quality of oral health and birth outcomes
Secondary ID [1] 281598 0
Nil
Universal Trial Number (UTN)
Trial acronym
MIOH-DS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral health status in pregnant women 287881 0
Condition category
Condition code
Public Health 288249 288249 0 0
Health promotion/education
Public Health 288254 288254 0 0
Health service research
Reproductive Health and Childbirth 288255 288255 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1: This group wil receive a midwifery intervention only (Oral health education, assessment and referrals to dental services). This group will receive oral health promotional material at the time of recruitment. This group will also receive a midwifery intervention which will involve midwives providing the following at the 1st antenatal visit:

Oral Health education: Midwives will emphasise the importance of oral health during pregnancy and provide information about oral hygiene instructions and dietary counselling.
Brief oral assessment: As part of the antenatal check up, midwives (trained in oral assessment) will conduct brief oral assessments of pregnant women using an oral assessment tool and if required, conduct a visual examination of the oral cavity to confirm any concerns. Prior to the trial all midwives will be required to complete an online educational program and assessment exercise to ensure that they have adequate knowledge about oral health care and are competent to conduct oral assessments.

Referrals: In this group, all pregnant women assessed to have a dental problem will be referred to existing dental services (either private, public or health fund) for treatment.
The referral letter provided to pregnant women will include a covering letter and a checklist of date of first visit, total number of visits required, treatment completed (item numbers), and dentists contact details to be completed by the dentists and returned to the study investigators via the reply paid envelope provided or fax .

The midwifery intervention (involving oral health education assessment and referral) will be of 5-8 minutes duration and will be conducted once at the first antenatal appointment

Intervention group 2: : This group will receive the Midwifery Intervention (as in Intervention group 1) and Dental Intervention (Oral health assessment and treatment by a Dentist at a free dental service close to the recruitment hospitals). This group will receive oral health promotional material at the time of recruitment. This group will also receive a midwifery and dental intervention. The midwifery intervention will be similar to Intervention group 1. However, in this group all pregnant women, regardless of whether they are assessed to have a dental problem or not by the midwife, will be referred (referral letter with check list) to the study dentists for an initial dental oral assessment. This is to allow further validation of the oral assessment tool and to gather baseline data on oral health. Further, pregnant women who consent will be provided with vouchers that will entitle them to priority access to free dental assessment and treatment at dental clinics in South Western Sydney and Nepean Blue Mountain Local health District. This service will be an extra service created specifically for this study. The dental vouchers will be valid for 4 weeks from the date of booking visit to encourage pregnant women to see the dentist at the earliest time. Pregnant women can make the dental appointment by calling the study phone number provided with the referral letter or contacting the recruiting dental assistant in the antenatal waiting room

Dental intervention: At the first dental appointment all the women will undergo detailed pre-oral assessment that will include medical history, followed by oral mucosal tissue examination, periodontal examination, dental caries examination and denture evaluation. A provisional diagnosis and treatment plan will be made for those women having oral health problems. Once the consent for treatment is obtained, subsequent appointments will be made in the second trimester to complete all the urgent treatment for women having dental problems. Second semester (13-27 weeks) is considered a safe period to carry out necessary dental treatment. The completion of treatment will take 1 to 3 additional visits depending on the treatment plan. Women having complex treatment needs such as root canal treatment will be referred to the specialist for follow up care and will be excluded from the study. After each examination the participants will be provided oral health education including oral hygiene instructions, brushing and flossing instructions and dietary counselling.

The dental intervention will be provided by four dentists employed for the study. Prior to the trial the dentists will participate in a two hour education workshop. At the workshop, the standardized dental care protocol to follow during pregnancy will be discussed. In addition, training will be provided on the use of the oral health status measures and mock oral assessments will also be conducted to assess their inter-rater reliability. As mentioned above the dental intervention will involve an initial pre-oral assessment followed by 1- 3 dental visits depending on the treatment plan. Each dental visit will be of maximum one hour duration.

All women in the study including those in the control group, intervention group 1 and group 2 (with or without oral health problems) will undergo a final post-oral examination by the study dentists at 28-42 week gestation period. This exam will be similar to the initial oral examination and will include a detailed clinical assessment. All women will receive reminder cards from midwives followed up by telephone calls from the study admin assistant to attend their final dental oral assessments. Pregnant women in the control group identified with a dental problem will be referred to dental services after pregnancy.

The Midwifery Intervention will only be conducted for a specific duration (only at the 1st antenatal visit).
The duration of the dental intervention will differ on a case by case basis depending on the treatment plan (upto 4 dental visits)
Intervention code [1] 286129 0
Early detection / Screening
Intervention code [2] 286130 0
Prevention
Intervention code [3] 286131 0
Behaviour
Comparator / control treatment
This group is the 3rd arm of the study. Participants in this group will not receive any Midwifery or Dental Intervention (current practice). This group will receive oral health promotional material at the time of recruitment. They will not receive any intervention from midwives or dentists until the completion of the trial. At the point of completion, these women will be referred to dental services, if required. In current practice, at the first antenatal appointment midwives undertake a complete health assessment of pregnant women. However, no oral assessment is done at this time.
Control group
Active

Outcomes
Primary outcome [1] 288435 0
The uptake of dental services (atleast one dental consultation during pregnancy)
Timepoint [1] 288435 0
The uptake of dental services will be assessed from the following sources:
-post questionnaire: The post questionnaire will be administered to all participants at 28-42 weeks gestation period (within 16-22 weeks after randomisation). The post questionnaire will have similar items to the pre questionnaire (demographic data, dental/medical aspects of the women?s health such as uptake of dental services, quality of oral health and post-test oral health knowledge). Contact details of private dentists who were consulted during pregnancy will also be sought in the post questionnaire.
- the returned checklist: Assessed within 16-22 weeks after randomisation.
- the database of the dental clinics
- following up all referrals by midwives and at the final dental oral assessment period
- contacting private/health fund dentists that were used by the women (contact details obtained from the post questionnaire and returned checklist).
Secondary outcome [1] 300155 0
Specificity and sensitivity of midwifery oral assessment- assessed by validating the midwife oral assessment tool against 2 gold standards namely the OHIP-14 questionnaire (completed at the time of recruitment: pre-questionnaire) in IG1 and IG2 and the initial dental oral assessment conducted by the 2 study dentists in IG2. The OHIP-14 questionnaire has been used as the gold standard in previous studies to validate oral assessment tools. The 2 study dentists will be trained to follow a standardised dental protocol during pregnancy. Adherence to the protocol will be evaluated by assessing the returned checklist.
Timepoint [1] 300155 0
This outcome will be assessed when:

- the study dentists conduct the initial dental oral assessment of pregnant women in Intervention group 2 (IG2). The initial dental oral assessment will be done in the second trimester (13-27 weeks gestation or 1- 7 weeks after randomisation) as this is the saftest period to undertake dental procedures. The dental vouchers provided to the pregnant women in IG2 will have 4 weeks validity to ensure that they see the dentists at the earliest. The exact timepoint for this outcome will be determined when the pre oral assessment is conducted.

- the participants complete the prequestionnaire (containing the OHIP 14 items) at the time of recruitment
Secondary outcome [2] 300156 0
Oral Health Knowledge- assessed using a pre-test and post-test questionnaire at the recruitment and post dental oral assessment period respectively.
Timepoint [2] 300156 0
Oral health knowledge will be assessed by comparing data from a pre test questionaire (administered to all participants at the time of recruitment (12- 20 weeks gestation) and a post-test questionnaire (administered to all participants at 28-42 weeks gestation period (within 16-22 weeks after randomisation).
Secondary outcome [3] 300157 0
Quality of oral health- assessed using a validated item in the pre and post-test questionnaire
Timepoint [3] 300157 0
Quality of oral health will be assessed by comparing data from a pre test questionaire (administered to all participants at the time of recruitment (12- 20 weeks gestation) and a post-test questionnaire (administered to all participants at 28-42 weeks gestation period (within 16-22 weeks after randomisation).
Secondary outcome [4] 300158 0
Oral health status involving the following measures:

-Gingival inflammation and bleeding : The Sulcus bleeding index will be used to measure the degree of inflammation and bleeding in the gums

-Clinical Attachment Loss (CAL): The degree of CAL (periodontal pocket depth, gingival recession and calculus) will be assessed using a calibrated periodontal probe.
-Level of plaque: The Approximal plaque index will be used to measure the level of plaque.
-Dental caries: The amount of dental caries will be determined by the decayed, missing, filled teeth (DMFT) index. The DMFT index will be used to monitor the changes in the various components. If the intervention is successful decayed teeth will have been filled or removed.
Timepoint [4] 300158 0
The oral health status will be assessed at the initial dental oral assessment period (13-27 weeks gestation or 1- 7 weeks after randomisation) and final oral assessment period (28-42 weeks gestation period or 16-22 weeks after randomisation).
Secondary outcome [5] 300159 0
Birth outcomes: Gestational age at birth and birth weight will be obtained from the Obstet data system (ODS) using data items/definitions from the NSW Midwives Data Collection. Data from ODS will be accessed using the women?s medical record numbers and date of birth which are collected at recruitment.
Timepoint [5] 300159 0
The birth outcomes will be assessed when the pregnant women have delivered their baby (usually between 37-42 weeks gestation or 25-30 weeks after randomisation)

Eligibility
Key inclusion criteria
- More than 18 years of age;
-Do not have cardiac disease that would warrant the need of antibiotics for dental treatment;
- Have not received dental treatment in the current pregnancy
- Have a single pregnancy of more than 12 and less than 20 weeks of gestational age;
- Do not have any known foetal anomalies or other risk factors that would place the pregnancy at risk of complications;
- Are able to attend regularly for dental treatment if required.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Have cardiac disease that would warrant the need of
antibiotics for dental treatment;
- Have received dental treatment in the current pregnancy
- More than 20 weeks of gestational age;
- Multiple pregnancy;
- Have known foetal anomalies or other risk factors that
would place the pregnancy at risk of complications;
- Unable to attend regularly for dental treatment if required.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pregnant women will be allocated to the groups using block randomisation. A permuted block randomisation scheme (computer generated) with a random mixture of block sizes will be used to set the allocation order, stratifying participants by hospital and presence of a dental problem. Randomisation will be accomplished centrally (NHMRC, Clinical Trials Centre) although each hospital will have its own randomisation scheme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pregnant women will be recruited from antenatal clinics across three large metropolitan hospitals in Western Sydney (Nepean, Campbelltown & Fairfield Hospital). Information about the study and Flyers will be provided to all pregnant women attending their first antenatal visit (booking visit). At all antenatal clinics the first booking visit is attended by midwives. While waiting to see the midwife, pregnant women will be invited to participate by an independent recruiter (dental assistant).Informed written consent will be obtained by the dental assistant from pregnant women who meet the study criteria. A self-administered pre-questionnaire containing items relating to baseline demographic data, dental/medical aspects of the women’s health, pre-test oral health knowledge and the OHIP-14 will be provided to pregnant women.

Pregnant women will be allocated to the groups using block randomisation. A permuted block randomisation scheme (computer generated) with a random mixture of block sizes will be used to set the allocation order, stratifying participants by hospital and presence of a dental problem. Randomisation will be accomplished centrally (NHMRC, Clinical Trials Centre) although each hospital will have its own randomisation scheme. Block randomisation will ensure that the number of participants in each arm of the trial will be evenly balanced.

Group allocation will be represented by coloured sheets in randomisation envelopes. After recruitment and baseline data collection, the dental assistant will contact a central number for group allocation and will hand over the relevant randomisation envelope to the pregnant women which will be given to the midwife. All midwives at each of the hospitals will be aware which group each coloured sheet represents.

Randomisation done centrally will minimise selection bias by the dental assistants. In addition, the study investigators will be blinded to group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 6066 0
2750
Recruitment postcode(s) [2] 6067 0
2176
Recruitment postcode(s) [3] 6068 0
2560

Funding & Sponsors
Funding source category [1] 286409 0
Government body
Name [1] 286409 0
NHMRC program grant
Address [1] 286409 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 286409 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre for Applied Nursing Research- University of Western Sydney/South Western Sydney Local Health District/Ingham Institute of Applied Medical Research
Address
Locked Bag 7103
Liverpool BC
NSW 1871
Country
Australia
Secondary sponsor category [1] 285193 0
University
Name [1] 285193 0
University of Western Sydney
Address [1] 285193 0
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country [1] 285193 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288485 0
Sydney Local Health District Human Research Ethics Committee- CRGH
Ethics committee address [1] 288485 0
Concord Repatriation General Hospital
Concord
NSW 2139
Ethics committee country [1] 288485 0
Australia
Date submitted for ethics approval [1] 288485 0
20/12/2011
Approval date [1] 288485 0
05/04/2012
Ethics approval number [1] 288485 0
HREC/11/CRGH/289

Summary
Brief summary
Poor oral health during pregnancy can affect the well being of the mother and baby. Poor maternal oral health increases the chance of infants developing early dental decay and is strongly associated with adverse pregnancy outcomes such as preterm and low birth weight babies. Unfortunately, many expectant mothers are unaware of the implications of poor oral health. Further, due to various reasons, many women do not seek dental care during pregnancy. According to new Perinatal Oral Health guidelines, dental treatment is safe during pregnancy and this is the period when mothers need to be screened for oral risks, counseled on oral hygiene and receive necessary dental treatment. To achieve this, prenatal care providers need to play an important role. At present there is a lack of emphasis being placed on perinatal oral health by prenatal care providers in Australia. Pregnant women, have no system in place that can offer them regular oral assessment during pregnancy and prompt dental treatment at minimal or no cost as experienced in other countries. To address the oral health needs of pregnant women, the study investigators have developed a unique midwifery initiated oral health dental service (MIOH-DS) model to promote and maintain maternal oral health. This service incorporates oral health guidelines into normal midwifery practice and provides appropriate care pathways where pregnant women can be referred for prompt dental treatment. Extensive pilot work has been conducted by the study investigators to develop the MIOH-DS. We now propose to test the MIOH-DS more extensively through a mulitcentre randomised trial across three large hospitals in Western Sydney

The aim of this study is to determine the effectiveness of a Midwife Initiated Oral Health-Dental Service (MIOH-DS). The MIOH-DS will provide pregnant women with oral assessments and dental referrals by midwives, and provide dental services which we expect will improve women’s oral health status, uptake of dental services, oral health knowledge, quality of oral health, and potentially influence the incidence of low birth weight and preterm births.
We anticpate that pregnant woman receiving the MIOH-DS will have, a 20% increase in the access/uptake of dental services; a 30% improvement in women’s oral health and a 30% increase in their knowledge about maternal oral health.
Trial website
Trial related presentations / publications
1. George, A., Johnson, M., Blinkhorn, A., Ajwani, S, Bhole, S., Yeo, A.E. & Ellis, S. (2012- in press) The oral health status, practices and knowledge of pregnant women in South-western Sydney. The Australian Dental Journal.

2. George, A., Shamim, S., Johnson, M., Dahlen, H., Ajwani, S., Bhole, S., Yeo, A.E. (2012) How Do Dental and Prenatal Care Practitioners Perceive Dental Care During Pregnancy? Current Evidence and Implications. Birth: Issues in Perinatal Care, 39 (3), 238-247.

3. George, A., Duff, M., Ajwani, S., Johnson, M., Dahlen, H., Blinkhorn, A., Ellis S. & Bhole, S. (2012) The development of an online education program for midwives in Australia to improve perinatal oral health. Journal of Perinatal Education, 21 (2), 112-122.

4. George, A. (2011) "Response to 'Treatment of periodontal infection does not reduce the rates of poor pregnancy outcomes'". International Journal of Evidence-Based Healthcare, 9, 451.

5. George, A., Johnson, M., Duff, M., Ajwani, S., Bhole, S., Blinkhorn, A., & Ellis, S. (2011) Midwives and oral health care during pregnancy: Perceptions of pregnant women in South-Western Sydney, Australia. Journal of Clinical Nursing. 21, 1087-1096.

6. George, A., Shamin, S., Johnson, M., Ajwani, S., Bhole, S., Blinkhorn, A., Ellis S. & Andrews, K. (2011). Periodontal treatment during pregnancy and birth outcomes: A meta-analysis of randomised trials. International Journal of Evidence-Based Healthcare, 9, 122-147.

7. George, A., Johnson, M., Blinkhorn, A., Ellis, S., Bhole, S. Ajwani, S. (2010) Promoting oral health during pregnancy: Current evidence and implications for Australian midwives. Journal of Clinical Nursing. 19, 3324-3333.

8. George, A., Johnson, M., Duff, M., Blinkhorn, A., Ajwani, S., Bhole, S. & Ellis, S. (2011) Maintaining oral health during pregnancy: Perceptions of midwives in Southwest Sydney. Collegian. 18, 71-79.

9. George, A. & Johnson, M. Ellis, S. Dahlen, H., Blinkhorn, A., Bhole, S. & Ajwani, S. (2010) Promoting dental health in pregnant women: A new role for midwives in Australia. Australian Nursing Journal, 18(1), 37.
Public notes

Contacts
Principal investigator
Name 34992 0
Dr Ajesh George
Address 34992 0
Centre for Applied Nursing Research
Ingham Institute Applied Medical Research
Locked Bag 1871
Liverpool BC
NSW 1871
Country 34992 0
Australia
Phone 34992 0
+61287389356
Fax 34992 0
+61 2 8738 9206
Email 34992 0
ajesh.george@sswahs.nsw.gov.au
Contact person for public queries
Name 18239 0
Dr Ajesh George
Address 18239 0
Centre for Applied Nursing Research
Ingham Institute Applied Medical Research
Locked Bag 1871
Liverpool BC
NSW 1871
Country 18239 0
Australia
Phone 18239 0
+61287389356
Fax 18239 0
+61 2 8738 9206
Email 18239 0
ajesh.george@sswahs.nsw.gov.au
Contact person for scientific queries
Name 9167 0
Dr Ajesh George
Address 9167 0
Centre for Applied Nursing Research
Ingham Institute Applied Medical Research
Locked Bag 1871
Liverpool BC
NSW 1871
Country 9167 0
Australia
Phone 9167 0
+61 2 87389356
Fax 9167 0
+61 2 8738 9206
Email 9167 0
ajesh.george@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results