Condition category
Pregnancy and Childbirth
Date applied
15/02/2010
Date assigned
22/04/2010
Last edited
18/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.health.qld.gov.au/mackay/default.asp

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

Publication citations

Additional files

Editorial Notes

18/03/2016: Publication reference added.