Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000040864
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
10/01/2012
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on acceptability of intrauterine contraceptive devices and implanon post childbirth
Scientific title
A pilot study of women in the immediate post partum period examining the acceptability of intrauterine devices and implants, the continuity rates of both devices at 6 months and the expulsion rates of intrauterine devices.
Secondary ID [1] 279689 0
Nil
Universal Trial Number (UTN)
U1111-1126-9295
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post partum contraception 285518 0
Condition category
Condition code
Reproductive Health and Childbirth 285709 285709 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot cohort study in which women will be approached to take part in the antenatal or early post natal period and explained the advantages and disadvantages of immediate post partum insertion of an IUD or an implant. Women having an elective caesarean section can elect to either have an IUD device placed at the time of surgery or an implant placed in the postnatal ward. Women requiring an emergency caesarean section or those having a vaginal delivery will only be able to choose the implant for immediate postpartum insertion. Women in those groups wanting an IUD will be referred for interval insertion 6-12 weeks postpartum. We will follow women up clinically at 6 weeks and then at 6 months and 12 months via email or telephone contact. The implants can remain in place for up to 3 years, the intrauterine copper device (depending on the type) for 5-10 years and the intrauterine system for 5 years. These methods can be removed at any time if the woman experiences sides effects or wishes to conceive.
Intervention code [1] 283983 0
Treatment: Drugs
Intervention code [2] 283986 0
Treatment: Devices
Intervention code [3] 283987 0
Prevention
Comparator / control treatment
The acceptibility of implants and IUDs will be compared
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286239 0
To document the safety and acceptability of intrauterine devices and implants inserted immediately post partum.
Timepoint [1] 286239 0
At 6 weeks the woman will be assessed clinically to confirm that the device is correctly placed and to document any any side effects experienced to that point. Women will also be asked to complete a questionnaire about their satisfaction with the method. At 6 and 12 months post partum women will be contacted via email or telephone and asked to complete a questionnaire to record side effects and satisfaction with the method.
Secondary outcome [1] 295427 0
To determine ongoing use of these methods at 12 months
Timepoint [1] 295427 0
Women will be contacted at 6 and 12 months post partum via email or phone and asked to complete a structure questionnaire about their continued use of their chosen method and if they have ceased using the method what were the primary reasons

Eligibility
Key inclusion criteria
Women who are having an elective caesarean section (IUDs and implants) or are within 48 hours of a vaginal birth (implants only)
Women who want immediate post partum contraception
Women who consent to the procedure of IUD insertion
Women who understand the additional potential risks of IUD expulsion and the theoretical but unproven risk of hormones on breast milk
Women who are willing to present for a clinical follow up 6 weeks after discharge
Women who are willing to be contacted after 6 and 12 months
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
Women with abnormal uterine shape (congenital uterine anomalies or fibroids impinging on the uterine cavity)
Women having an emergency caesarean section
Women with allergy to copper, polyethylene or levonorgesterel
Women with a current history of carcinoma in situ or cervical cancer
Women with a diagnosis or receiving treatment for chorioamnionitis
Women with prelabour rupture of membranes for more than 24 hours
Women with postpartum haemorrhage as defined by need for transfusion, or an estimated blood loss greater than 1,000mL
Women with premature rupture of membranes (pregnancy less than 34 weeks)
Women with a history of sexually transmitted infection during pregnancy
Women unable to understand English and consent to the procedure

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)
This is a pilot cohort study in which women will be approached to take part in the antenatal or early post natal period and explained the advantages and disadvantages of immediate post partum insertion of an IUD or an implant. Women will be free to choose which method they wish to use and will be given a script to obtain the implant or IUD prior to their admission for delivery. Women having an elective caesarean section will have the device placed at the time of surgery. Women having a vaginal birth will have the implant inserted on the postnatal ward but the IUD inserted after 6-12 weeks as an interval insertion. We will follow women up clinically at 6 weeks and then at 6 and 12 months via email or telephone contact.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2012
Actual
18/04/2012
Date of last participant enrolment
Anticipated
30/12/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11493 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 11494 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 4850 0
2050
Recruitment postcode(s) [2] 23517 0
2050 - Camperdown
Recruitment postcode(s) [3] 23518 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 284471 0
Self funded/Unfunded
Name [1] 284471 0
Kirsten Black
Country [1] 284471 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Department of Women's and Babies
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
New South Wales
Country
Australia
Secondary sponsor category [1] 283397 0
University
Name [1] 283397 0
University of Sydney
Address [1] 283397 0
Department of Obstetrics and Gynaecology
University of Sydney
NSW 2006
Country [1] 283397 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286454 0
Sydney South West Area Health Research Ethics (RPAH zone)
Ethics committee address [1] 286454 0
Research Ethics Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
NSW
Ethics committee country [1] 286454 0
Australia
Date submitted for ethics approval [1] 286454 0
15/01/2012
Approval date [1] 286454 0
09/04/2012
Ethics approval number [1] 286454 0

Summary
Brief summary
The aim is to undertake a pilot study to examine the acceptability, side effects and continuation rates of immediate post partum insertion of intrauterine devices and implants in women desiring long term but reversible contraception.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33604 0
A/Prof Kirsten Black
Address 33604 0
Associate Professor Kirsten Black
Joint Head of the Discipline of Obstetrics, Gynaecology and Neonatology
Medical Foundation Building
The University of Sydney Central Clinical School
Faculty of Medicine and Health
Sydney 2006 NSW
Country 33604 0
Australia
Phone 33604 0
+61290363125
Fax 33604 0
Email 33604 0
kirsten,[email protected]
Contact person for public queries
Name 16851 0
Kirsten Black
Address 16851 0
Associate Professor Kirsten Black
Joint Head of the Discipline of Obstetrics, Gynaecology and Neonatology
Medical Foundation Building
The University of Sydney Central Clinical School
Faculty of Medicine and Health
Sydney 2006 NSW
Country 16851 0
Australia
Phone 16851 0
+61 2 95157696
Fax 16851 0
+61 2 95153359
Email 16851 0
[email protected]
Contact person for scientific queries
Name 7779 0
Kirsten Black
Address 7779 0
Associate Professor Kirsten Black
Joint Head of the Discipline of Obstetrics, Gynaecology and Neonatology
Medical Foundation Building
The University of Sydney Central Clinical School
Faculty of Medicine and Health
Sydney 2006 NSW
Country 7779 0
Australia
Phone 7779 0
+61290363125
Fax 7779 0
+61 2 95153359
Email 7779 0
[email protected]

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

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