Email updates

Keep up to date with the latest news and content from BMC Pregnancy and Childbirth and BioMed Central.

Open Access Study protocol

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial

Marianne AC Verschoor12*, Marike Lemmers134, Patrick M Bossuyt5, Giuseppe CM Graziosi6, Petra J Hajenius1, Dave J Hendriks2, Marcel AH van Hooff7, Hannah S van Meurs1, Brent C Opmeer8, Maurits W van Tulder9, Liesanne Bouwma10, Ruby Catshoek11, Peggy Geomini12, Ellen R Klinkert13, Josje Langenveld14, Theodoor E Nieboer15, J Marinus van der Ploeg16, Celine M Radder17, Taeke Spinder18, Lucy F van der Voet19, Ben Willem J Mol1, Judith AF Huirne4 and Willem M Ankum1

Author Affiliations

1 Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands

2 Department of Obstetrics and Gynaecology, Amphia Hospital, Breda, The Netherlands

3 Department of Obstetrics and Gynaecology, Flevo Hospital, Almere, The Netherlands

4 Department of Obstetrics and Gynaecology, VU Medical Centre, Amsterdam, The Netherlands

5 Department of Clinical Epidemiology, University of Amsterdam, Amsterdam, the Netherlands

6 Department of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, the Netherlands

7 Department of Obstetrics and Gynaecology, St. Franciscus Hospital, Rotterdam, The Netherlands

8 Clinical Research Unit, Academic Medical Centre, Amsterdam, the Netherlands

9 Department of Health Sciences & EGMO + Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University, Amsterdam, The Netherlands

10 Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, ‘s Hertogenbosch, the Netherlands

11 Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands

12 Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands

13 Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, the Netherlands

14 Department of Obstetrics and Gynaecology, Atrium Medical Centre, Heerlen, the Netherlands

15 Department of Obstetrics and Gynaecology, Radbout University, Nijmegen Medical Centre, Nijmegen, the Netherlands

16 Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, the Netherlands

17 Department of Obstetrics and Gynaecology, St Lucas Andreas Hospital, Amsterdam, the Netherlands

18 Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands

19 Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, the Netherlands

For all author emails, please log on.

BMC Pregnancy and Childbirth 2013, 13:102  doi:10.1186/1471-2393-13-102

Published: 2 May 2013

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.

Trial registration

Dutch Trial Register: NTR3110

Keywords:
Curettage; Expectant management; Incomplete evacuation; Miscarriage; Misoprostol