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Trial registered on ANZCTR


Registration number
ACTRN12614000558628
Ethics application status
Approved
Date submitted
8/12/2013
Date registered
26/05/2014
Date last updated
26/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Uterine cavity length in postpartum women who are exclusively breastfeeding: is atrophy responsible for a higher perforation rate at Intrauterine Contraceptive Device (IUCD) insertion?
Scientific title
Do breast feeding women 2-6 months postpartum have a shorter intrauterine cavity length when measured on transvaginal ultrasound scan, compared with non breastfeeding women 2-6 months postpartum and non breastfeeding women greater than 6 months postpartum.
Secondary ID [1] 283721 0
nil known
Universal Trial Number (UTN)
U1111-1151-1666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine perforation at insertion of intrauterine contraceptive device (IUD) in postpartum breastfeeding and non breastfeeding women 290686 0
Effect of breast feeding on uterine cavity length & fundal myometrial thickness 290687 0
Condition category
Condition code
Reproductive Health and Childbirth 291054 291054 0 0
Contraception
Reproductive Health and Childbirth 291055 291055 0 0
Breast feeding
Reproductive Health and Childbirth 291056 291056 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study - comparing intrauterine cavity length & fundal myometrial thickness in breastfeeding women 2-6 months postpartum with non breastfeeding women 2-6 months postpartum and non-breastfeeding women greater than 6month postpartum and premenopausal by using a single cross-sectional transvaginal ultrasound measurement.
Intervention code [1] 288415 0
Not applicable
Comparator / control treatment
Measurement of non breastfeeding women 2-6 months postpartum and non-breastfeeding women greater than 6 months postpartum and premenopausal by using a single cross-sectional transvaginal ultrasound measurement.
Control group
Active

Outcomes
Primary outcome [1] 291047 0
Intrauterine cavity length measuews by transvaginal ultrasound scan in milimeters.
Timepoint [1] 291047 0
Single point observational measurement.
Secondary outcome [1] 305889 0
Fundal myometrial thickness measured on transvaginal ultrasound in milimeters.
Timepoint [1] 305889 0
Single point observational measurement

Eligibility
Key inclusion criteria
Group 1
Parity >/=1
> 6 months postpartum and premenopausal
Not breastfeeding for at least 2 months

Group 2
Parity >/=1
2-6 months postpartum exclusively breast feeding
Amenorrhoeic

Group 3
Parity >/=1
2-6 months postpartum bottle feeding from 6 weeks
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known uterine pathology (fibroids, arcuate uterus, bicornuate uterus)
Nulliparity
Intrauterine device in situ
Using hormonal contraception
Pregnant

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
A power calculation was carried out with the assistance of a University of Otago statistician, Professor Peter Herbison. Based on a 80% power and an a of 0.05, we need to recruit 22 women per group to be able to detect a difference of 15 mm in uterine cavity length between the groups.

Groups will be compared using a chi2 to establish:

1. A difference between cavity length in breastfeeding versus non-breastfeeding women

2. A difference between cavity length in postpartum women and non-postpartum women

3. A difference between fundal myometrial thickness in breastfeeding versus non-breastfeeding women

4. A difference between fundal myometrial thickness in postpartum women and non-postpartum women

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 5669 0
New Zealand
State/province [1] 5669 0

Funding & Sponsors
Funding source category [1] 288396 0
Hospital
Name [1] 288396 0
Department of Women's and Children's Health Research Committee Grant
Department of Women's and Children's Health
Dunedin Public Hospital
Country [1] 288396 0
New Zealand
Funding source category [2] 288397 0
University
Name [2] 288397 0
University of Otago Research Grant
University of Otago
Country [2] 288397 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Paterson
Address
Department of Women’s and Children's Health,
Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin
9016
Country
New Zealand
Secondary sponsor category [1] 287099 0
Individual
Name [1] 287099 0
Dr James Arcus
Address [1] 287099 0
Department of Women's Health
Dunedin Public Hospital
201 Great King Street
Private bag 1921
Dunedin 9054
New Zealand
Country [1] 287099 0
New Zealand
Secondary sponsor category [2] 287100 0
Individual
Name [2] 287100 0
Dr Catherine Coffey
Address [2] 287100 0
c/o Dr Helen Paterson
Department of Women's and Children's Health,
Dunedin School of Medicine, University of Otago
PO Box 913
Dunedin 9016
New Zealand
Country [2] 287100 0
New Zealand
Secondary sponsor category [3] 287101 0
Individual
Name [3] 287101 0
Gaye Ellis
Address [3] 287101 0
Department of Women’s and Children's Health,
Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin. 9016
New Zealand
Country [3] 287101 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290280 0
Central Regional Ethics Committee
Ethics committee address [1] 290280 0
Central Regional Ethics Committee
c/- Ministry of Health
PO Box 5013
1 the Terrace
Wellington 6011
New Zealand
Ethics committee country [1] 290280 0
New Zealand
Date submitted for ethics approval [1] 290280 0
Approval date [1] 290280 0
12/12/2013
Ethics approval number [1] 290280 0
CEN/12/04/008

Summary
Brief summary
Postpartum breastfeeding women have a higher risk of uterine perforation with insertion of an intrauterine contraception device (IUD). The mechanism for this is unknown, we hypothesize that a reduction in uterine cavity length is responsible for the increased perforation rate. Perforation is a serious complication, which requires surgery to remove the perforated IUD, resulting in a significant cost to the woman and the health service. Our objective is to compare uterine cavity length in exclusively breastfeeding women with non-breastfeeding women. A smaller sized cavity may explain the increased risk of perforation in breastfeeding women, leading to a change in practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44826 0
Dr Helen Paterson
Address 44826 0
Department of Women’s and Children's Health,
Dunedin School of Medicine, University of Otago, PO Box 56, Dunedin 9016
Country 44826 0
New Zealand
Phone 44826 0
+64 027 2785900
Fax 44826 0
Email 44826 0
[email protected]
Contact person for public queries
Name 44827 0
Dr James Arcus
Address 44827 0
Department of Women's and Children's Health.
Dunedin Public Hospital.
201 Great King Street
Private Bag 1921
Dunedin 9054
New Zealand
Country 44827 0
New Zealand
Phone 44827 0
+64 3 474 0999
Fax 44827 0
Email 44827 0
[email protected]
Contact person for scientific queries
Name 44828 0
Dr James Arcus
Address 44828 0
Department of Women's and Children's Health.
Dunedin Public Hospital.
201 Great King Street
Private Bag 1921
Dunedin 9054
New Zealand
Country 44828 0
New Zealand
Phone 44828 0
+64 3 474 0999
Fax 44828 0
Email 44828 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

Documents added manually
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Documents added automatically
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