Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial)BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.38828.593125.55 (Published 25 May 2006) Cite this as: BMJ 2006;332:1235
- J Trinder, specialist registrar in obstetrics and gynaecology ()1,
- P Brocklehurst, director2,
- R Porter, consultant obstetrician and gynaecologist3,
- M Read, consultant obstetrician and gynaecologist4,
- S Vyas, consultant obstetrician and gynaecologist1,
- L Smith, general practitioner5
- 1 Southmead Hospital, Westbury-on-Trym, Bristol BS10 5NB
- 2 National Perinatal Epidemiology Unit, University of Oxford, Oxford OX3 7LF
- 3 Royal United Hospital, Bath BA1 3NG
- 4 Gloucestershire Royal NHS Hospital, Gloucester GL1 3NN
- 5 East Somerset Research Consortium, West Coker, Somerset BA22 9AH
- Correspondence to: J Trinder, Consultant in Maternal Medicine and Obstetrics, Department of Obstetrics and Gynaecology, St Michael's Hospital, Southwell St, Bristol BS2 8EG
- Accepted 9 March 2006
Objective To ascertain whether a clinically important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage.
Design Randomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage.
Setting Early pregnancy assessment units of seven hospitals in the United Kingdom.
Participants Women of less than 13 weeks' gestation, with a diagnosis of early fetal demise or incomplete miscarriage.
Interventions Expectant management (no specific intervention); medical management (vaginal dose of misoprostol preceded, for women with early fetal demise, by oral mifepristone 24-48 hours earlier); surgical management (surgical evacuation).
Main outcome measures Confirmed gynaecological infection at 14 days and eight weeks; need for unplanned admission or surgical intervention.
Results 1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management. No differences were found in the incidence of confirmed infection within 14 days between the expectant group (3%) and the surgical group (3%) (risk difference 0.2%, 95% confidence interval − 2.2% to 2.7%) or between the medical group (2%) and the surgical group (0.7%, − 1.6% to 3.1%). Compared with the surgical group, the number of unplanned hospital admissions was significantly higher in both the expectant group (risk difference − 41%, − 47% to − 36%) and the medical group (− 10%, − 15% to − 6%). Similarly, when compared with the surgical group, the number of women who had an unplanned surgical curettage was significantly higher in the expectant group (risk difference − 39%, − 44% to − 34%) and the medical group (− 30%, − 35% to − 25%).
Conclusions The incidence of gynaecological infection after surgical, expectant, and medical management of first trimester miscarriage is low (2-3%), and no evidence exists of a difference by the method of management. However, significantly more unplanned admissions and unplanned surgical curettage occurred after expectant management and medical management than after surgical management.
Trial registration National Research Register: N0467011677/N0467073587.
A list of investigators and centres is on bmj.com
We thank the Clinical Trials Service Unit, Oxford, for providing telephone randomisation and Sarah Ayers at the National Perinatal Epidemiology Unit, Oxford, for writing the data entry program and for providing data for analysis. We also thank Steering Committee members G Stirrat (Bristol), D Mant (Oxford), R Bender Attik (Miscarriage Association), and C Law (Southampton) for their guidance during the trial and Data Monitoring Committee members D Elbourne (London), D Jewell (Bristol), P Ewings (Taunton), and J Friend (Plymouth). A list of investigators and centres is on bmj.com.
Contributors JT, PB, and LS prepared the manuscript. JT, RP, SV, and LS conceived the trial. LS was the trial grant lead. JT, PB, RP, MR, SV, and LS designed and coordinated the trial. JT, LS, and PB coordinated the data collection. PB did the statistical analysis. JT is the guarantor.
Funding The MIST study was funded by a South and West NHS Executive research and development grant. A donation of £20 000 was accepted from Exelgyn. Neither the NHS Executive nor Exelgyn had any role in the study design; collection, analysis, or interpretation of data; writing of the report; or the decision to submit the paper for publication.
Competing interests The study group accepted a donation of £20 000 from Exelgyn, the manufacturers of mifepristone. The authors have no other competing interests.
Ethical approval Multicentre Research Ethics Committee (MREC/97/6/24) and local research ethics committee approval for each centre.