ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12613001356752

Ethics application status

Not yet submitted

Date submitted

2/12/2013

Date registered

11/12/2013

Date last updated

11/12/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Reducing unplanned pregnancy in women in drug and alcohol health services

Scientific title

Improving uptake of long acting contraceptive methods and reducing unplanned pregnancy in women in drug and alcohol health services: Evaluation of a pilot

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1150-9065

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Unplanned pregnancy

Long acting reversible contraceptive (LARC) methods

Women attending drug and alcohol treatment services

Condition category

Condition code

Reproductive Health and Childbirth

Contraception

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A three month lead in period will measure the rate of uptake of contraception in the standard care scenario within a drug and alcohol treatment service. After 3 months, an integrated contraception clinic will be established and women invited to attend. All participants will be followed up at 12 months.

This integrated contraceptive clinic will employ a medical officer for one session every second week (0.05FTE). All doctors employed will be specifically trained and accredited in family planning and will offer women participants the range of contraceptive options as per standard care including condoms, pills and LARC methods. If a LARC method is chosen then standard care involves follow-up of patients with implants at 2 weeks and IUDs at 6 weeks post-insertion. Treatment will be delivered according to current clinical practice guidelines developed by family planning organisations across Australia.

All women accessing the drug health service will be initially screened for eligibility by their treating multidisciplinary team who regularly undertake physical, mental and social health assessments on their clients. These clients will be invited to take part and will be referred to the research nurse who will obtain informed consent and conduct baseline interviews.

Intervention code [1]

Prevention

Comparator / control treatment

1-3 months: External referral
Eligible women enrolled and referred to appropriate external services for their contraceptive needs (general practitioner, Family Planning services or community health) as per standard care.

Control group

Historical

Outcomes

Primary outcome [1]

Self-reported unplanned pregnancy measured via self-report in a structured interview (12 months post baseline). Also consent will be obtained to access medical records including pregnancy services.

Timepoint [1]

12 months after baseline interview

Secondary outcome [1]

Self-reported increased use of long acting reversible contraceptive measured via structured interview (12 months post baseline) and, where possible, medical record review.

Timepoint [1]

12 months after baseline interview

Eligibility

Key inclusion criteria

a) female patient of the drug and alcohol service; b) aged between 18 and 49 years; c) heterosexually active as defined as any heterosexual activity within the past 12 months; d) currently using no contraception, using less reliable contraceptive methods (e.g. withdrawal, rhythm, condoms, oral contraceptive) or considering a change of method; e) expects to be available for follow-up at 12 months; f) able to provide informed consent, including unaffected by substance use (intoxicated or in withdrawal), and adequate English language to complete study procedures.

Minimum age

18 Years

Maximum age

49 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

a) women with serious mental or physical illness or disability likely to impact on capacity to complete study procedures or uptake of a contraceptive method; b) opposed to the use of contraception on religious or other grounds; c) women who are pregnant at the time; d) women who are planning a pregnancy.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/02/2014

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

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Kirsten Black

Address [1]

Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Kirsten Black

Address

Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Sydney Local Health Distriact Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/12/2013

Approval date [1]

Ethics approval number [1]

HREC/13/RPAH/532

Summary

Brief summary

Women who misuse alcohol and other drugs have low rates of contraceptive use and higher rates of pregnancies
(including unplanned pregnancies) compared to the general population. Once pregnant, these women and their
babies experience higher rates of adverse health outcomes such as preterm birth, low birth weight and adverse
developmental and social outcomes. Our research aims to explore whether women in drug and alcohol treatment
who do not wish to conceive will have better rates of contraceptive use when contraceptive services are integrated into drug treatment clinics, compared to standard care where women are referred to primary health care services for their contraceptive needs. With this model we seek to increase use of all contraceptive methods but particularly methods that do not require daily adherence such as injections, implants and intrauterine devices that are reversible but extremely reliable. These methods are known collectively as the long acting reversible contraceptive (LARC) methods.

A pilot integrated contraceptive medical service will be introduced within a drug and alcohol clinical setting. We
propose to evaluate this pilot, to determine whether integrated care is feasible, and if it is more effective in
increasing the use of contraceptive methods and reducing unplanned pregnancy than the standard of care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kirsten Black

Address

Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9515 7245

Fax

kirsten.black@sydney.edu.au

Contact person for public queries

Name

Kirsten Black

Address

Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9515 7245

Fax

kirsten.black@sydney.edu.au

Contact person for scientific queries

Name

Kirsten Black

Address

Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9515 7245

Fax

kirsten.black@sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
New Record*	Study results article	Yes	https://doi.org/10.1111/1753-6405.13025		Day et al 2020 Contraception clinic.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

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