Hum. Reprod. Advance Access originally published online on May 20, 2004
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Human Reproduction, Vol. 19, No. 7, 1618-1621,
July 2004
© 2004 European Society of Human Reproduction and Embryology
Vaginal misoprostol for cervical ripening before operative hysteroscopy in pre-menopausal women: a double-blind, placebo-controlled trial with three dose regimens
1 Service de Gynécologie-Obstétrique, Hôpital Antoine Béclère, Assistance Publique-Hôpitaux de Paris (AP-HP), 157 rue de la Porte-de-Trivaux, 92141 Clamart cedex and 2 Service de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, 1, Avenue Claude Vellefaux, 75475 Paris cedex 10, France
3 To whom correspondence should be addressed. e-mail: herve.fernandez{at}abc.ap-hop-paris.fr
BACKGROUND: To evaluate the effects of vaginal misoprostol on cervical dilatation before operative hysteroscopy in pre-menopausal women. METHODS: Four groups of 12 women were randomly assigned to receive either placebo or vaginal misoprostol in doses of 200, 400 or 800 µg 4 h before the surgical procedure. The number of patients was calculated with an
= 0.01 and
=0.20 for a difference of 50%. The primary outcome measure was cervical width, assessed by the largest size of Hegar dilator that could be inserted without resistance. The secondary outcomes were subjective assessments of the ease of dilatation and pre-operative pain, as well as adverse effects and complications. RESULTS: There was no difference in the baseline diameter of the cervical opening between the placebo group (6.1 ± 1.4 cm) and the misoprostol groups (6.3 ± 2.1 cm). The groups did not differ significantly in the time required for dilatation, ease of dilation, or the number of adverse effects. Pre-operative pain, evaluated by a pain scale, was greater in the treatment groups and was rated at 2.5 ± 2.3 (P = 0.015), 2.4 ± 1.2 (P = 0.073) and 2.8 ± 2.9 (P = 0.012) respectively for each increasing dose group. CONCLUSIONS: Vaginal misoprostol applied 4 h before operative hysteroscopy at three different doses did not reduce the need for cervical dilatation, did not facilitate hysteroscopic surgery, and increased pre-operative pain.
Key words: cervical ripening/misoprostol/operative hysteroscopy/pre-menopausal women/vaginal route
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