Misoprostol Prior to IUD Insertion in Nullipara
Study Details
Study Description
Brief Summary
The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Vaginal Misoprostol Group Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion |
Drug: Vaginal misoprostol
To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women
Other Names:
|
| Placebo Comparator: Placebo group Vaginal placebo tablets 4 hours prior to IUD insertion |
Drug: Vaginal misoprostol
To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cervical dilatation [four hours after misoprostol use]
the frequency of women with cervical dilation ≤ 4 mm (measured by inserting a #4 Hegar dilator through the internal orifice of the cervix uteri immediately prior to IUD insertion
Secondary Outcome Measures
- Difficulty in inserting IUD [four hours after misoprostol use]
subjective difficulty (as reported by the investigator) in inserting the IUD and classified as difficult, very difficult and easy
- Pain at insertion [four hours after misoprostol use]
judged subjectively by the woman and evaluated by the investigator using a visual analogue scale (VAS). The scale ranged from 0 to 10, in which zero is the absence of pain and 10 the worst pain imaginable.
Other Outcome Measures
- Subjective sensation as reported by the woman [four hours after misoprostol use]
the woman's subjective evaluation of the procedure (IUD insertion)was classified as not disagreeable, slightly disagreeable, disagreeable or very disagreeable.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Nulliparous women
-
No chirurgical procedure in the cervix
-
Wish to use IUD as a contraceptive method
Exclusion criteria are as follows:
-
Presence of active cervical infection visible upon speculum exam (purulent cervicits)
-
Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
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Pregnancy ending less than 6 weeks prior to enrollment in study
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History of prior IUD placement
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History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
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History of uterine surgery
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Allergy or intolerance to misoprostol or other prostaglandin
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Undiagnosed abnormal vaginal bleeding
-
Malignancy of the genital tract
-
Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
-
Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Medicina Integral Professor Fernando Figueira | Recife | Pernambuco | Brazil | 50070450 |
Sponsors and Collaborators
- Instituto Materno Infantil Prof. Fernando Figueira
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MISO DIU 01