A randomised trial of placement of Mirena at caesarean section or postpartum
| ISRCTN | ISRCTN94164946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94164946 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Mackay Base Hospital
Bridge Road
Mackay
4740
Australia
| Phone | +61 (0)7 49686000 |
|---|---|
| kathleen_braniff@health.qld.gov.au |
Study information
| Study design | Multicentre randomised open-label pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/05/2010 |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
4740
Australia
Sponsor information
Mackay District of Queensland Health (Australia)
Government
Government
c/o Dr David Farlow
Director of Medical Services Mackay District
Mackay Base Hospital
Mackay, Queensland
4740
Australia
| Phone | +61 (0)4 17754042 |
|---|---|
| kathleen_braniff@health.qld.gov.au | |
| Website | http://www.health.qld.gov.au/mackay/default.asp |
"ROR" |
https://ror.org/00c1dt378 |
Funders
Funder type
Government
Mackay District of Queensland Health (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
18/03/2016: Publication reference added.
