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|Title:||Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial|
van Hooff, M.
van Meurs, H.
van Tulder, M.
van der Ploeg, J.
van der Voet, L.
|Citation:||BMC Pregnancy and Childbirth, 2013; 13(102):1-5|
|Marianne AC Verschoor, Marike Lemmers, Patrick M Bossuyt, Giuseppe CM Graziosi, Petra J Hajenius, Dave J Hendriks, Marcel AH van Hooff, Hannah S van Meurs, Brent C Opmeer, Maurits W van Tulder, Liesanne Bouwma, Ruby Catshoek, Peggy Geomini, Ellen R Klinkert, Josje Langenveld, Theodoor E Nieboer, J Marinus van der Ploeg, Celine M Radder, Taeke Spinder, Lucy F van der Voet, Ben Willem J Mol, Judith AF Huirne, Willem M Ankum|
|Abstract:||Background: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol. Methods/Design: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization. Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients’ quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry. Discussion: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.|
|Keywords:||Curettage; Expectant management; Incomplete evacuation; Miscarriage; Misoprostol|
|Rights:||© Verschoor et al.; licensee BioMed Central Ltd. 2013 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.|
|Appears in Collections:||Paediatrics publications|
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