Improving maternal and infant outcomes: A multicentre randomised controlled trial of midwifery and dental intervention

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)