To investigate whether Misoprostol (compared to placebo) will diminish the amount of insertion failures. To investigate whether Misoprostol (compared to placebo) will diminish the amount of insertion related complications (eg. syncope, perforation…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of failed insertions
Secondary outcome
The amount of insertion related failures.
The subjectively experienced pain by the patient, recorded by VAS (Visual
analog Scale).
Background summary
It is known that insertion of IUD, especially with nullipara, sometimes fail or
happen to be complicated (eg. by syncope, perforation of cervix or uterus or by
creating a false passage) mostly due to severe cervical stenosis, immature
cervix or significant anteflexion or retroflexion.
According to our hypothesis Misoprostol will cause softening and dilatation of
the cervix which will diminish the amount of insertion failure and insertion
related complications.
Study objective
To investigate whether Misoprostol (compared to placebo) will diminish the
amount of insertion failures.
To investigate whether Misoprostol (compared to placebo) will diminish the
amount of insertion related complications (eg. syncope, perforation of uterus
or cervix).
To investigate whether Misoprostol (compared to placebo) will diminish the
subjectively experienced pain by the patient, recorded by a Visual Analog Pain
Scale.
Study design
Randomised, double blind, placebo controlled study which will take place at the
outpatient clinic of the Leiden University Medical Centre and a couple
affiliated hospitals.
Intervention
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 are required to lie down for half an
hour.
Study burden and risks
A possible risk of participating in this trial, which might be a burden as
well, is the risk of side-effects of Misoprostol. These are as followed:
Side-effects Misoprostol: (mostly dose-dependent) diarrhoea, abdominal pain,
nausea, flatulence, vertigo, headache, constipation, vomiting, fever, dyspepsia
and gynaecologic complaints like vaginal bleeding.
The patient will have to make one or two extra outpatient clinic visits because
of her participation in this trial. This could be a time burden.
Other examinations, as eg. gynaecological examination and STD-screening, will
not differ from examinations taken without participation in the trial.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
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
• Pregnancy
• Lactation
• <6 weeks post-partum
• PID (Pelvic inflammatory disease)
• STD (sexually transmitted disease, like Chlamydia or Gonorrhea)
• Conus uteri
• Cervixcarcinoma
• Prostaglandin allergy
• Severely impaired liverfunction
• Cerebrovasculair disease
• Cavum uteri < 5cm of >9cm
• Undiagnosed abnormal uterine bleeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006897-60-NL |
| CCMO | NL15826.058.07 |