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

Conditions: Insertion of Intra Uterine Device (IUD)It is known that insertion of IUD 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.
MedDRA version: 9.1Level: HLTClassification code 10017847Term: Gastric ulcers and perforation

Registration Number: EUCTR2006-006897-60-NL

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

-Women, >18 years, who require IUD (as an anticonceptive or as a way of treatment eg. by mennorragic complaints)
-The IUD can be inserted any time during the menstrual cycle.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnancy
-Lactation
-<6 weeks post partum
-Pelvic Inflammatory Disease
-Sexually Transmitted Disease
-Cervix carcinoma (or conus uteri)
-Allergy to prostaglandines
-Severely impaired liver functions
-Undiagnosed abnormal uterine bleeding
-Vasculair disease
-Cavum uteri <5cm or >9cm

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -To investigate whether Misoprostol (compared to placebo) will diminish the amount of insertion failures. ;Secondary Objective: -To investigate whether Misoprostol (compared to placebo) will diminish the amount of insertion related complications (eg. syncope, perforation of uterus or cervix) and expulsions.<br>-To compare the subjectively experienced pain by the patient, recorded by a Visual Analog Pain Scale. ;Primary end point(s): -The amount of failed insertions

Secondary Outcome Measures