The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001537246
Ethics application status
Approved
Date submitted
7/09/2018
Date registered
13/09/2018
Date last updated
13/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Training midwives in the insertion of contraceptive implants to increase uptake in the immediate postpartum period: a feasibility pilot study
Scientific title
Training midwives in the insertion of contraceptive implants to increase uptake in the immediate postpartum period: a feasibility pilot study
Secondary ID [1] 296004 0
MISP - 58225
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unintended pregnancy 309562 0
Condition category
Condition code
Reproductive Health and Childbirth 308388 308388 0 0
Contraception
Public Health 308389 308389 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All nurses and midwives working in antenatal and postnatal care at participating hospitals (Royal Prince Alfred Hospital; RPAH, and Canterbury Hospital; CH) will be invited to complete a baseline survey assessing their current levels of contraception knowledge and attitudes towards midwives providing contraception counselling and Implanon NXT® insertion in the postnatal setting.

General contraception training will be provided by Family Planning NSW (FPNSW) to all midwives and nurses working in antenatal and postnatal care at participating hospitals. The training will focus on contraceptive options, education and counselling for postpartum women. This will be provided as a 20-30 minute group education sessions during routine ward and lunchtime meetings. Light refreshments will be provided as appropriate. There will be no cost to participate. A recorded webinar will also be made available online. CPD (continuing professional development) points will be accrued for participating. The purpose of this education will be to provide information about contraception options (including but not limited to Implanon NXT®) and counselling in order to increase knowledge of midwives and nurses working in these settings. Additional resources will also be provided including the contraception efficacy card and web links to other FPNSW resources to use with patients. This will be important for this study (as well as for general professional development) as different midwives and nurses may interact with patients while at the hospital and it will be important for them to be aware of different contraceptive options and how to discuss them. The midwives will also be reminded of the study during the education. This will facilitate the recruitment of midwives into the study and inform other midwives and nurses about the availability of Implanon NXT® insertion for their patients.

Of those who attend the general training, a subset of all midwives will self-select for Implanon NXT® (Etonogestrel) insertion training (“Implanon NXT® Insertion Training Course for Registered Nurses and Midwives” provided by Family Planning NSW). The course is a competency-based program run by FPNSW, designed to build nurses' and midwives' skills in Implanon NXT® procedures. The course has been available for several years through Family Planning NSW.

The course combines online and face-to-face learning, simulated practice, and supervised clinical training and competency assessment. The number, length, and location of training sessions are:

Online theory – approximately 2-3 hours – Managed online through Moodle
Face-to-Face theory and simulated practice – 1 session, approximately 1.5 hours – at RPA and Canterbury Hospitals
Supervised clinical practice until deemed competent for two insertions — < 1 month period – at RPA and Canterbury Hospitals.

Certified clinicians experienced in contraceptive implant insertions will supervise participants until they are confident in completing the procedure without assistance. Participants must complete at least two supervised competent insertions where the implant is in the correct location and easily palpable to meet FPNSW current training requirements.

Five midwives will undertake clinical training per month, over a six-month period. Clinical supervision and mentoring will be provided by PI Black. However, the midwife ‘champions’ will be trained first and credentialed as trainers, so they will then be able to supervise their colleagues in this procedure.

An example of the video used in the training to provide an overview of the insertion process can be found here: https://bit.ly/2m8lfkJ

Note: Training will only be available for Implanon NXT® insertion, not removal, as is appropriate for this particular hospital setting. Locations for removal will be discussed with patients at the time of the insertion.

Participants in the Implanon NXT® insertion training program will complete a pre-training survey to identify existing knowledge, confidence, expectations and concerns, and a post-training survey to further explore knowledge, confidence and concerns. Midwives will also log their post-training implementation data using the Ethica platform (www.ethicadata.com). The app will be used by midwives to log all Implanon NXT® insertions over a six month period after they have achieved competency in the insertion procedure. After the six-month post-competency period is complete, midwives will be invited to participate in short, semi-structured interviews to explore their experiences of inserting Implanon NXT® in the postpartum setting, as well as challenges and enabling factors in relation to their practice.

All midwives working in participating hospitals will be invited to complete an endline survey to determine current levels of contraception knowledge and attitudes towards midwives providing contraception counselling and Implanon NXT® insertion in the postnatal setting.
Intervention code [1] 312368 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307413 0
Primary Outcome 1: Change in self-reported knowledge of midwives completing Implanon training:
A composite score from the Likert scale ratings (Strongly Agree to Strongly Disagree) to the following statements:

• I think I have the depth of knowledge I need in order to counsel women appropriately regarding advantages of the contraceptive implant
• I think I have the depth of knowledge I need in order to counsel women appropriately regarding disadvantages of the contraceptive implant
• I think I have the depth of knowledge I need in order to counsel women appropriately regarding side effects of the contraceptive implant
• I think I have the depth of knowledge I need in order to counsel women appropriately regarding contraindications of the contraceptive implant
• I think I have the knowledge I need to discuss how bleeding patterns may change for women using the contraceptive implant
• I think I have the knowledge I need to discuss how women can manage altered bleeding patterns that result from using the contraceptive implant
• I think I have the knowledge I need to discuss all forms of Long-Acting Reversible Contraception including:
• contraceptive implant
• IUDs
• depot injection
• I think I have the knowledge I need to enable women to make informed decisions about which method of contraception is most suitable for them

Note, outcomes from individual questions may also be reported separately.
Timepoint [1] 307413 0
Measured in the pre-training survey (immediately before starting the online training modules) and the post-training survey (on completion of supervised clinical practice).
Primary outcome [2] 307414 0
Primary Outcome 2: Change in knowledge of midwives completing Implanon training as measured by quiz scores:
A composite score from the accuracy on the following 12 quiz questions (responses are multiple choice: True/False/Unsure):
Current use of anticoagulant medication is an absolute contraindication (MEC 4) to Implanon NXT® insertion

Lignocaine with Adrenaline can be used with caution in patients with severe or untreated hypertension

When inserting Implanon NXT® the correct procedure is to puncture skin at insertion site with tip of needle at approx. 60º angle

Women who experience irregular bleeding with Implanon NXT® in the first 3 months of use can be reassured that 50% of all users will develop amenorrhoea by 12 months

Implanon NXT® is a progestogen only method of contraception

Implanon NXT® is not suitable for women under 18

Implanon NXT® is not suitable for women over 45

Implanon NXT® is not recommended for women at high risk of venous thromboembolism

Liver enzyme inducing medications will not interfere with the efficacy of Implanon NXT® as it is not absorbed orally

Implanon NXT® should be removed or replaced after two years of use

It is recommended that Implanon NXT® be inserted under the skin in the non-dominant arm

Implanon NXT® is suitable for breast feeding women

Note, outcomes from individual questions may also be reported separately.
Timepoint [2] 307414 0
Measured in the pre-training survey (immediately before starting the online training modules) and the post-training survey (on completion of supervised clinical practice).
Primary outcome [3] 307415 0
Primary Outcome 3: Self-reported confidence of midwives after Implanon training:
Participant responses to the question:
Having completed the theory and simulation practice on the model arm during your training, did you then feel confident inserting a contraceptive implant into a patient?
Timepoint [3] 307415 0
Measured in the post-training survey (on completion of supervised clinical practice).
Secondary outcome [1] 351849 0
Primary Outcome 4: Post-training confidence in insertion without supervision:
Participant responses to the question:
How confident do you feel now to insert contraceptive implants without direct supervision?
Timepoint [1] 351849 0
Time point: Measured in the post-training survey (on completion of supervised clinical practice).
Secondary outcome [2] 351850 0
Primary Outcome 5: Change in proportion of patients with whom contraception is discussed by all midwives.
Change in average response to the following question:
What proportion of women that you see do you discuss contraceptive options with?
Timepoint [2] 351850 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).
Secondary outcome [3] 351851 0
Primary Outcome 6: Change in the attitudes of all midwives as to whether providing contraceptive counselling is part of their role
Measured by response (multiple choice: Yes/Sometimes/No/Unsure) to the following question:
Do you think providing information about contraception is part of a midwife’s role?
Timepoint [3] 351851 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).
Secondary outcome [4] 351852 0
Primary Outcome 7: Change in attitudes of all midwives to the perceived value of contraceptive information.
Measured by response on Likert scale (Strongly Agree to Strongly Disagree) to the following statement:
I think information about contraception provided in the immediate post-partum period is valuable to women.
Timepoint [4] 351852 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).
Secondary outcome [5] 351853 0
Primary Outcome 8: Change in attitudes of midwives to the perceived importance of contraceptive counselling as an aspect of their job
Measured by response on Likert scale (Strongly Agree to Strongly Disagree) to the following statement:
I believe providing contraception counselling is an important aspect of a midwife’s job
Timepoint [5] 351853 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).
Secondary outcome [6] 351854 0
Primary Outcome 9: Number of implant insertions during study period according to data logged by midwives in the Ethica app
Timepoint [6] 351854 0
Data collected continuously up until 6 months post-competency
Secondary outcome [7] 351855 0
Secondary Outcome 1: Change in duration of contraception discussions by all midwives.
Average of responses to the question:
On average, what is the duration of contraceptive discussions you have?
Timepoint [7] 351855 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).
Secondary outcome [8] 351857 0
Secondary Outcome 2: Change in the contraception methods that midwives can discuss
Average responses to the question:
What aspects of contraception are you comfortable discussing? (select all that apply) with the options:
Combined oral contraceptive pills (“The Pill”)
Progesterone-only pill (Mini-pill)
Implanon
IUDs
Lactational amenorrhea
Barrier methods (condoms)
Tubal ligation
Partner vasectomy
None
Timepoint [8] 351857 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).
Secondary outcome [9] 351859 0
Secondary Outcome 3: Change in knowledge of all midwives as measured by quiz scores:
A composite score from the accuracy on the following 15 quiz questions (responses are multiple choice: True/False/Unsure):
Non-breastfeeding women may become pregnant from unprotected sex from day 21 post-partum
The Progesterone-only pill (“Mini pill”) is the only safe hormonal option in the immediate post-partum period for breastfeeding women
The Combined Oral Contraceptive pill (“The Pill”) should not be used by breastfeeding women until at least 6 months post-partum
Current use of anticoagulant medication is an absolute contraindication (MEC 4) to Implanon NXT® insertion
Lignocaine with adrenaline can be used with caution in patients with severe or untreated hypertension
When inserting Implanon NXT® the correct procedure is to puncture skin at insertion site with tip of needle at approx. 60° angle
Women who experience irregular bleeding with Implanon NXT® in the first 3 months of use can be reassured that 50% of all users will develop amenorrhoea by 12 months
Implanon NXT® is a progestogen only method of contraception
Implanon NXT® is not suitable for women under 18
Implanon NXT® is not suitable for women over 45
Implanon NXT® is suitable for breastfeeding women
Implanon NXT® is not recommended for women at high risk of venous thromboembolism
Liver enzyme inducing medications will not interfere with the efficacy of Implanon NXT® as it is not absorbed orally
Implanon NXT® should be removed or replaced after two years of use
It is recommended that Implanon NXT® be inserted under the skin in the non-dominant arm
And the question:
What methods do you think are suitable for a woman in the immediate post-partum period? (Tick all that apply)

Combined Oral Contraceptive pills (“The Pill”)
Progesterone-only Pill (Mini-pill)
Implanon
Hormonal IUD (e.g., Mirena)
Non-hormonal IUD (e.g. Copper IUD)
Lactational Amenorrhea
Barrier methods (condoms)
None

Note, outcomes from individual questions may also be reported separately.
Timepoint [9] 351859 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).
Secondary outcome [10] 351860 0
Change in midwives experiences of providing contraceptive counselling.
This outcome is measured from the responses of three contingent questions:
Do you have any experience in providing contraception counselling to women?
Yes (Please provide details)
No
Do you provide contraceptive counselling to women as part of your current role?
Yes (Go to next question)
No (End)
At what stage do you provide contraceptive counselling? (Tick as many as apply) Options for this question are Yes / No / N/A for each option
During antenatal visits
During antenatal classes
During postpartum care on the ward
During postnatal home visits
Other (Please specify)
Timepoint [10] 351860 0
Measured in the baseline survey (during their regular shifts in the 4 weeks prior prior to the commencement of general contraceptive training to all midwives) and in the endline survey (at the end of the study).

Eligibility
Key inclusion criteria
Midwives are the primary participants for this study. Any Registered Midwife practicing in RPAH or Canterbury Hospital postnatal wards, birth centres or and Midwifery Group Practice that has an ongoing minimum workload of one shift per week will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Midwives who do not have regular shifts at the participating hospitals or whose supervisors do not support their participation in the Implanon® NXT insertion training program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The anticipated number of participating midwives is 30. This is based on a training rate of five midwives per month for six months. This will be offered to the first 30 midwives who express interest and consent/enrol in the study. Ideally there will be a balance of midwives participating from each hospital.

• Data cleaning and logic check will be conducted for survey data and data collected by the Ethica App. All data will be converted and analysed in SAS 9.3.
• We will calculate descriptive statistics (e.g. means and proportions where appropriate) to describe the sample.
• Linear mixed models will be used to examine changes in knowledge scores, and other continuous variables, between the pre- and post-training surveys. Binary outcomes (e.g. proportion of nurses who are deemed competent) will be reported with 95% confidence intervals. As the same midwife may see more than one woman, confidence intervals for binary outcomes at the woman level (e.g. proportion of insertion successful insertions not requiring assistance) will be adjusted for clustering.
• Thematic analysis will be used to identify, analyse and report themes within the interview data. All qualitative data will be organised and analysed using NVivo software.

Recruitment
Recruitment status
Not yet 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)
NSW
Recruitment hospital [1] 11816 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 11817 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 23943 0
2050 - Camperdown
Recruitment postcode(s) [2] 23944 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 300598 0
Commercial sector/Industry
Name [1] 300598 0
Merck Sharp & Dohme (Australia) Pty Limited
Address [1] 300598 0
Level 1 - Building A, 26 Talavera Road
Macquarie Park, NSW, 2113
Country [1] 300598 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Family Planning NSW
Address
328-336 Liverpool Road,
Ashfield, NSW, 2131
Country
Australia
Secondary sponsor category [1] 300129 0
None
Name [1] 300129 0
None
Address [1] 300129 0
None
Country [1] 300129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301386 0
Family Planning NSW HREC
Ethics committee address [1] 301386 0
328-336 Liverpool Road,
Ashfield, NSW, 2131
Ethics committee country [1] 301386 0
Australia
Date submitted for ethics approval [1] 301386 0
31/07/2018
Approval date [1] 301386 0
29/08/2018
Ethics approval number [1] 301386 0
R2018/05

Summary
Brief summary
The aim of this study is to determine whether midwives can contribute to the provision of contraception, particularly the insertion of Implanon NXT®, in the Australian hospital setting in the immediate postpartum period.. Participating midwives will be provided with training regarding contraceptive counselling, Implanon NXT® insertion, and how to implement this in the postpartum setting. It is standard practice for midwives to insert contraceptive implants in the postpartum period in other countries, however this is most commonly done by medical officers in NSW hospitals, and is not current practice by midwives. It is hypothesised that providing contraceptive training will increase provision of contraception in this setting, and improve confidence of midwives in providing contraceptive counselling and implant insertions. Providing this training to midwives may influence attitudes to contraception provision in this setting, but it is not possible to hypothesise the direction of this change.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86830 0
Ms Jessica Botfield
Address 86830 0
Family Planning NSW
328-336 Liverpool Road,
Ashfield, NSW, 2131
Country 86830 0
Australia
Phone 86830 0
+61 2 87524334
Fax 86830 0
Email 86830 0
jessicab@fpnsw.org.au
Contact person for public queries
Name 86831 0
Ms Jessica Botfield
Address 86831 0
Family Planning NSW
328-336 Liverpool Road,
Ashfield, NSW, 2131
Country 86831 0
Australia
Phone 86831 0
+61 2 87524334
Fax 86831 0
Email 86831 0
researchcentre@fpnsw.org.au
Contact person for scientific queries
Name 86832 0
Ms Jessica Botfield
Address 86832 0
Family Planning NSW
328-336 Liverpool Road,
Ashfield, NSW, 2131
Country 86832 0
Australia
Phone 86832 0
+61 2 87524334
Fax 86832 0
Email 86832 0
researchcentre@fpnsw.org.au

No data has been provided for results reporting
Summary results
Not applicable