Does Misoprostol facilitate insertion of an Intra Uterine Device (IUD), both copper-containing as well as levonorgestrel-releasing, among nulli- and multipara?

Does Misoprostol facilitate insertion of an Intra Uterine Device (IUD), both copper-containing as well as levonorgestrel-releasing, among nulli- and multipara? - Misoprostol before IUD-insertion

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30516

Enrollment

270

Registered

2007-02-01

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

IUD-insertion complications

Interventions

133 patients will receive 400 µg Misoprostol and 133 deelnemers will receive placebo which they'll have to administer themselves vaginally three hours befoe IUD insertion. After administration they

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients who want an IUD to be inserted can be included, regardless of the reason for IUD insertion, which can be a IUD as a contraceptive or a IUD as a therapeutic method for eg. hypermennoroeic complaints. The IUD insertion can take place any moment during the menstrual cycle.

Exclusion criteria

Exclusion criteria: • Pregnancy • Lactation • 9cm • Undiagnosed abnormal uterine bleeding

Design outcomes

Primary

Measure	Time frame
The amount of failed insertions	—

Secondary

Measure	Time frame
The amount of insertion related failures. The subjectively experienced pain by the patient, recorded by VAS (Visual analog Scale).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)