Contact information
Type
Scientific
Primary contact
Dr Kathleen Braniff
ORCID ID
Contact details
Mackay Base Hospital
Bridge Road
Mackay
4740
Australia
+61 (0)7 49686000
kathleen_braniff@health.qld.gov.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A multicentre, randomised trial of placement of the Mirena, intrauterine contraceptive device at caesarean section or postpartum
Acronym
Study hypothesis
Insertion of Mirena at time of caesarean section is a safe effective contraceptive option
Ethics approval
Not available at time of registration
Study design
Multicentre randomised open-label pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Contraception
Intervention
Insertion of Mirena either at the time of elective caesarean section or at the usual time of 6 weeks postpartum with follow up until 6 months postpartum
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Expulsion of Mirena
For the group having Mirena inserted at the time of caesarean section, all outcomes will be measured 6 weeks, 3 months and 6 months after delivery.
For the group who have the Mirena inserted 6 weeks after delivery, primary and secondary outcomes will be measured 3 months and 6 months after delivery.
Secondary outcome measures
1. Breastfeeding rates and breastfeeding difficulties
2. Babies weight gain
3. Vaginal bleeding
4. Pelvic infection
5. Strings not visible
6. Uterine perforation
7. Malposition of the device within the cavity
8. Ovarian cysts
9. Pregnancy
10. Patient satisfaction
Data for most variables above will be categorical (yes or no).
Infant weight gain (g) and estimated number of days vaginal bleeding in the past month will be numeric.
Patient satisfaction will be rated 1-5, from very poor to excellent.
For the group having Mirena inserted at the time of caesarean section, all outcomes will be measured 6 weeks, 3 months and 6 months after delivery.
For the group who have the Mirena inserted 6 weeks after delivery, primary and secondary outcomes will be measured 3 months and 6 months after delivery.
Overall trial start date
01/05/2010
Overall trial end date
30/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Women having an elective caesarean section, who choose to use Mirena for contraception
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
1. Suspected uterine infection
2. Uterine malformation
3. Cervical dysplasia
Recruitment start date
01/05/2010
Recruitment end date
30/04/2011
Locations
Countries of recruitment
Australia
Trial participating centre
Mackay Base Hospital
Mackay
4740
Australia
Sponsor information
Organisation
Mackay District of Queensland Health (Australia)
Sponsor details
c/o Dr David Farlow
Director of Medical Services Mackay District
Mackay Base Hospital
Mackay
Queensland
4740
Australia
+61 (0)4 17754042
kathleen_braniff@health.qld.gov.au
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Mackay District of Queensland Health (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26053465