A randomised trial of placement of Mirena at caesarean section or postpartum

ISRCTN	ISRCTN94164946
DOI	https://doi.org/10.1186/ISRCTN94164946
Protocol serial number	N/A
Sponsor	Mackay District of Queensland Health (Australia)
Funder	Mackay District of Queensland Health (Australia)

Submission date: 15/02/2010
Registration date: 22/04/2010
Last edited: 18/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kathleen Braniff
Scientific

Mackay Base Hospital
Bridge Road
Mackay
4740
Australia

Phone	+61 (0)7 49686000
Email	kathleen_braniff@health.qld.gov.au

Study information

Primary study design	Interventional
Study design	Multicentre randomised open-label pilot study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A multicentre, randomised trial of placement of the Mirena, intrauterine contraceptive device at caesarean section or postpartum
Study objectives	Insertion of Mirena at time of caesarean section is a safe effective contraceptive option
Ethics approval(s)	Not available at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	100
Key inclusion criteria	Women having an elective caesarean section, who choose to use Mirena for contraception
Key exclusion criteria	1. Suspected uterine infection 2. Uterine malformation 3. Cervical dysplasia
Date of first enrolment	01/05/2010
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

Australia

Study participating centre

Mackay Base Hospital

Mackay
4740
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/03/2016: Publication reference added.