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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Misoprostol Group | Active Comparator | Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion |
|
| Placebo group | Placebo Comparator | Vaginal placebo tablets 4 hours prior to IUD insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal misoprostol | Drug | To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical dilatation | 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 | four hours after misoprostol use |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulty in inserting IUD | subjective difficulty (as reported by the investigator) in inserting the IUD and classified as difficult, very difficult and easy | four hours after misoprostol use |
| Pain at insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective sensation as reported by the woman | the woman's subjective evaluation of the procedure (IUD insertion)was classified as not disagreeable, slightly disagreeable, disagreeable or very disagreeable. | four hours after misoprostol use |
Inclusion Criteria:
Exclusion criteria are as follows:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Integral Professor Fernando Figueira | Recife | Pernambuco | 50070450 | Brazil |
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|
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.
| four hours after misoprostol use |