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

A multicentre, randomised trial of placement of the Mirena, intrauterine contraceptive device at caesarean section or postpartum

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94164946
Enrollment
100
Registered
2010-04-22
Start date
2010-05-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception Pregnancy and Childbirth Contraceptive management

Interventions

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

Sponsors

Mackay District of Queensland Health (Australia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women having an elective caesarean section, who choose to use Mirena for contraception

Exclusion criteria

Exclusion criteria: 1. Suspected uterine infection 2. Uterine malformation 3. Cervical dysplasia

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026