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A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial.

Oppegaard KS, Lieng M, Berg A, Istre O, Qvigstad E, Nesheim BI - BJOG (2010)

Bottom Line: To compare the impact of 1000 microg of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after 2 weeks of pretreatment with estradiol vaginal tablets in postmenopausal women prior to day-care operative hysteroscopy.Self-administered vaginal misoprostol of 1000 microg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain.One thousand micrograms of self-administered vaginal misoprostol, 12 hours prior to day-care hysteroscopy, after 14 days of pretreatment with vaginal estradiol, has a significant cervical ripening effect compared with placebo in postmenopausal women.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynaecology, Helse Finnmark, Klinikk Hammerfest, Hammerfest, Norway. kevin.s.oppegaard@helse-finnmark.no

ABSTRACT

Objective: To compare the impact of 1000 microg of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after 2 weeks of pretreatment with estradiol vaginal tablets in postmenopausal women prior to day-care operative hysteroscopy.

Design: Randomised, double-blind, placebo-controlled sequential trial.

Setting: Norwegian university teaching hospital.

Population: Sixty-seven postmenopausal women referred for day-care operative hysteroscopy.

Methods: The women were randomised to receive either 1000 microg of self-administered vaginal misoprostol or self-administered vaginal placebo on the evening before day-care operative hysteroscopy. All women had administered a 25-microg vaginal estradiol tablet daily for 14 days prior to the operation.

Primary outcome: preoperative cervical dilatation at hysteroscopy.

Secondary outcomes: difference in dilatation at recruitment and before hysteroscopy, number of women who achieved a preoperative cervical dilatation of 5 mm or more, acceptability, complications and adverse effects.

Results: The mean cervical dilatation was 5.7 mm (SD, 1.6 mm) in the misoprostol group and 4.7 mm (SD, 1.5 mm) in the placebo group, the mean difference in cervical dilatation being 1.0 mm (95% CI, 0.2-1.7 mm). Self-administered vaginal misoprostol of 1000 microg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain.

Conclusions: One thousand micrograms of self-administered vaginal misoprostol, 12 hours prior to day-care hysteroscopy, after 14 days of pretreatment with vaginal estradiol, has a significant cervical ripening effect compared with placebo in postmenopausal women.

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Related in: MedlinePlus

Continuation of the sequential test. The stopping boundaries and the sample path leading to the conclusion that misoprostol was significantly superior to placebo is shown. H0, boundary for the  hypothesis; Ha, boundary for the alternative hypothesis.
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fig02: Continuation of the sequential test. The stopping boundaries and the sample path leading to the conclusion that misoprostol was significantly superior to placebo is shown. H0, boundary for the hypothesis; Ha, boundary for the alternative hypothesis.

Mentions: Between January 2008 and April 2009, 72 women were enrolled and randomly assigned to treatment (Figure 1). The stopping boundaries were reached on 13 May 2009 (Figure 2) as a result of a significant difference between the misoprostol and placebo groups on the primary efficacy outcome. The groups were well balanced in terms of baseline demographics (Table 1) and surgical characteristics (Table 2). The results for the cervical dilations are shown in Table 3. The mean cervical dilatation was 5.7 mm (SD, 1.6 mm) in the misoprostol group and 4.7 mm (SD, 1.5 mm) in the placebo group, the mean difference in cervical dilatation being 1.0 mm (95% CI, 0.2–1.7 mm). The cervical dilatations were normally distributed, assessed visually with a bell curve. The main adverse effect was lower abdominal pain (Table 4), although the majority of women reported mild pain. One woman who received misoprostol reported lower abdominal pain rated at a level of six out of 10 on a visual analogue scale score, but reported that her symptoms subsided after the intake of two 500-mg paracetamol tablets. A few of the women who experienced pain reported that they had taken off-prescription analgesics (such as paracetamol and ibuprofen) with a subsequent reduction in their symptoms. No women experienced severe pain (more than six out of 10 on a visual analogue scale score). Two women in the misoprostol group (6.1%) experienced light preoperative bleeding. Of the 67 women, 47 (70%) found self-administered vaginal capsules at home to be completely acceptable, 14 (21%) fairly acceptable, five (7.5%) fairly unacceptable and one (1.5%) completely unacceptable. The main reason given for unacceptability was the lack of vaginal applicators to aid insertion. There were two similar preoperative complications, one in each treatment group: perforation of the uterine fundus with the resectoscope after dilatation. Both women were discharged on the same day as surgery and neither experienced further complications or needed further treatment. No postoperative complications were recorded during the 14-day follow-up period.


A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial.

Oppegaard KS, Lieng M, Berg A, Istre O, Qvigstad E, Nesheim BI - BJOG (2010)

Continuation of the sequential test. The stopping boundaries and the sample path leading to the conclusion that misoprostol was significantly superior to placebo is shown. H0, boundary for the  hypothesis; Ha, boundary for the alternative hypothesis.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2805871&req=5

fig02: Continuation of the sequential test. The stopping boundaries and the sample path leading to the conclusion that misoprostol was significantly superior to placebo is shown. H0, boundary for the hypothesis; Ha, boundary for the alternative hypothesis.
Mentions: Between January 2008 and April 2009, 72 women were enrolled and randomly assigned to treatment (Figure 1). The stopping boundaries were reached on 13 May 2009 (Figure 2) as a result of a significant difference between the misoprostol and placebo groups on the primary efficacy outcome. The groups were well balanced in terms of baseline demographics (Table 1) and surgical characteristics (Table 2). The results for the cervical dilations are shown in Table 3. The mean cervical dilatation was 5.7 mm (SD, 1.6 mm) in the misoprostol group and 4.7 mm (SD, 1.5 mm) in the placebo group, the mean difference in cervical dilatation being 1.0 mm (95% CI, 0.2–1.7 mm). The cervical dilatations were normally distributed, assessed visually with a bell curve. The main adverse effect was lower abdominal pain (Table 4), although the majority of women reported mild pain. One woman who received misoprostol reported lower abdominal pain rated at a level of six out of 10 on a visual analogue scale score, but reported that her symptoms subsided after the intake of two 500-mg paracetamol tablets. A few of the women who experienced pain reported that they had taken off-prescription analgesics (such as paracetamol and ibuprofen) with a subsequent reduction in their symptoms. No women experienced severe pain (more than six out of 10 on a visual analogue scale score). Two women in the misoprostol group (6.1%) experienced light preoperative bleeding. Of the 67 women, 47 (70%) found self-administered vaginal capsules at home to be completely acceptable, 14 (21%) fairly acceptable, five (7.5%) fairly unacceptable and one (1.5%) completely unacceptable. The main reason given for unacceptability was the lack of vaginal applicators to aid insertion. There were two similar preoperative complications, one in each treatment group: perforation of the uterine fundus with the resectoscope after dilatation. Both women were discharged on the same day as surgery and neither experienced further complications or needed further treatment. No postoperative complications were recorded during the 14-day follow-up period.

Bottom Line: To compare the impact of 1000 microg of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after 2 weeks of pretreatment with estradiol vaginal tablets in postmenopausal women prior to day-care operative hysteroscopy.Self-administered vaginal misoprostol of 1000 microg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain.One thousand micrograms of self-administered vaginal misoprostol, 12 hours prior to day-care hysteroscopy, after 14 days of pretreatment with vaginal estradiol, has a significant cervical ripening effect compared with placebo in postmenopausal women.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynaecology, Helse Finnmark, Klinikk Hammerfest, Hammerfest, Norway. kevin.s.oppegaard@helse-finnmark.no

ABSTRACT

Objective: To compare the impact of 1000 microg of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after 2 weeks of pretreatment with estradiol vaginal tablets in postmenopausal women prior to day-care operative hysteroscopy.

Design: Randomised, double-blind, placebo-controlled sequential trial.

Setting: Norwegian university teaching hospital.

Population: Sixty-seven postmenopausal women referred for day-care operative hysteroscopy.

Methods: The women were randomised to receive either 1000 microg of self-administered vaginal misoprostol or self-administered vaginal placebo on the evening before day-care operative hysteroscopy. All women had administered a 25-microg vaginal estradiol tablet daily for 14 days prior to the operation.

Primary outcome: preoperative cervical dilatation at hysteroscopy.

Secondary outcomes: difference in dilatation at recruitment and before hysteroscopy, number of women who achieved a preoperative cervical dilatation of 5 mm or more, acceptability, complications and adverse effects.

Results: The mean cervical dilatation was 5.7 mm (SD, 1.6 mm) in the misoprostol group and 4.7 mm (SD, 1.5 mm) in the placebo group, the mean difference in cervical dilatation being 1.0 mm (95% CI, 0.2-1.7 mm). Self-administered vaginal misoprostol of 1000 microg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain.

Conclusions: One thousand micrograms of self-administered vaginal misoprostol, 12 hours prior to day-care hysteroscopy, after 14 days of pretreatment with vaginal estradiol, has a significant cervical ripening effect compared with placebo in postmenopausal women.

Show MeSH
Related in: MedlinePlus