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Trial registered on ANZCTR


Registration number
ACTRN12620001000998
Ethics application status
Approved
Date submitted
9/08/2020
Date registered
6/10/2020
Date last updated
6/10/2020
Date data sharing statement initially provided
6/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot feasibility study of the function of an intra-uterine device (IUD) insertion device in acute postpartum women.


Scientific title
A feasibility study to determine the ability of an intra-uterine device (IUD) insertion device to accurately place an IUD in acute postpartum women.
Secondary ID [1] 299744 0
None
Universal Trial Number (UTN)
U1111-1243-1643
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intrauterine Contraception 315111 0
Condition category
Condition code
Reproductive Health and Childbirth 313436 313436 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the insertion of a post-partum intrauterine device (PPIUD) using a dedicated prototype PPIUD insertion device designed specifically for post-partum use. The intervention will entail having a PPIUD (commercially available device, copper or hormone containing IUD) placed within 10 minutes of placental delivery following vaginal birth. The insertion procedure takes less than 5 minutes and is performed once. The device will be inserted by a trained delivery attendant who is part of the research team (senior doctor, midwife or nurse practitioner) using the dedicated prototype device. Bedside ultrasound will b used to verify correct device location inside the uterine cavity immediately following the insertion. Clinical notes will be reviewed to ensure adherence to planned treatment.
Intervention code [1] 316010 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321913 0
Proper function of the dedicated PPIUD inserter device as measured by the number of subjects with the IUD properly positioned at the fundus of the uterus with strings visible. This will be assessed by both clinical exam (visibility of strings) and by ultrasound.
Timepoint [1] 321913 0
Immediately post-insertion
5-10 days post-insertion
42-56 days post-insertion
Secondary outcome [1] 376660 0
Ease of use as rated by inserting clinician as assessed by a study-specific questionnaire.
Timepoint [1] 376660 0
Time of insertion.
Secondary outcome [2] 376661 0
Comfort of procedure as assessed by subject using a study-specific questionnaire (0-10 pain scale).
Timepoint [2] 376661 0
Immediately post-insertion.
Secondary outcome [3] 376662 0
Assessing by a rating scale if the subject would use the PPIUD method using the PPIUD insertion device again. This is a study-specific question using a Likert scale for rating.
Timepoint [3] 376662 0
42-56 days post-insertion.

Eligibility
Key inclusion criteria
1. Age 18 or older.
2. Immediately post vaginal delivery, within 10 minutes of placental delivery.
3. Previously expressed desire for PPIUD and has signed study consent documents.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active uterine infection and no fever in labour.
2. Having active sexually transmitted infection or other lower genital tract infection.
3. Known to have ruptured membranes for more than 24 hours prior to delivery.
4. Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myomas,
5. Manual removal of the placenta.
6. Unresolved postpartum haemorrhage or postpartum uterine atony requiring use of additional oxytocic agents in addition to Active Management of the third stage of labour.

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)
None.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The study is a small feasibility study of 10 subjects, intended to assess that the PPIUD insertion device functions as intended in human subjects. This is a descriptive study only.

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 outside Australia
Country [1] 22032 0
New Zealand
State/province [1] 22032 0
Otago

Funding & Sponsors
Funding source category [1] 304218 0
University
Name [1] 304218 0
University of Otago
Address [1] 304218 0
PO Box 56
Dunedin 9054
New Zealand
Country [1] 304218 0
New Zealand
Primary sponsor type
Individual
Name
Michael Stitely
Address
University of Otago
Department of Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 304457 0
None
Name [1] 304457 0
Address [1] 304457 0
Country [1] 304457 0
Other collaborator category [1] 281022 0
Individual
Name [1] 281022 0
Helen Paterson
Address [1] 281022 0
University of Otago
Department of Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
Country [1] 281022 0
New Zealand
Other collaborator category [2] 281023 0
Individual
Name [2] 281023 0
Emma Macfarlane
Address [2] 281023 0
University of Otago
Department of Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
Country [2] 281023 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304679 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 304679 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 304679 0
New Zealand
Date submitted for ethics approval [1] 304679 0
10/04/2020
Approval date [1] 304679 0
29/07/2020
Ethics approval number [1] 304679 0
20/STH/59

Summary
Brief summary
We plan to test a new prototype intrauterine contraceptive device (IUD) inserter designed specifically for postpartum use. The device has been tested in a simulation setting and functions as intended. The device has not been tried in human subjects. The reason for the study is to test that the device functions as intended in actual use.
Ten women will be enrolled. They will consent to have an IUD inserted after normal childbirth. A standard IUD that is already in routine clinical use will be inserted, using the new inserter. The location of the IUD will be confirmed by ultrasound at the time of insertion, within 5-10 days of insertion, and at 42-56 days after insertion.
The clinician inserting the IUD (a member of the research team), and the woman receiving the IUD will complete brief surveys regarding their experiences with the use if the device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97834 0
A/Prof Michael Stitely
Address 97834 0
University of Otago
Department of Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
Country 97834 0
New Zealand
Phone 97834 0
+64034740999
Fax 97834 0
Email 97834 0
michael.stitely@otago.ac.nz
Contact person for public queries
Name 97835 0
A/Prof Michael Stitely
Address 97835 0
University of Otago
Department of Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
Country 97835 0
New Zealand
Phone 97835 0
+64034740999
Fax 97835 0
Email 97835 0
michael.stitely@otago.ac.nz
Contact person for scientific queries
Name 97836 0
A/Prof Michael Stitely
Address 97836 0
University of Otago
Department of Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
Country 97836 0
New Zealand
Phone 97836 0
+64034740999
Fax 97836 0
Email 97836 0
michael.stitely@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This small feasibility study is being conducted to support the regulatory approval process for the device being studied. The data will be shared in an online data repository (Harvard Dataverse or Figshare) if/when the device completes the regulatory approval process. Until that time this dataset is commercially sensitive.
What supporting documents are/will be available?
No other documents available
Summary results
No Results