MIST Flashcards Preview

Landmark Trials > MIST > Flashcards

Flashcards in MIST Deck (11)
Loading flashcards...
1

Journal
Year

BMJ (published 17 May 2006)

2

Aims

To ascertain whether a clinically important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage

3

Study Design

RCT comparing medical and expectant management with surgical management of first trimester miscarriages

4

Participants

- Early pregnancy assessment units of 7 hospitals in the UK
- 1200 women <13/40 with diagnosis of early fetal demise or incomplete miscarriage (399 conservative, 398 medical, 403 surgical)

5

Inclusion Criteria

- Women with pregnancy of <13/40 with either incomplete miscarriage or early fetal/embryonic demise

6

Exclusion Criteria

- Severe haemorrhage or pain, pyrexia above 37.5C, severe asthma, haemolytic disease or blood dyscrasias, current anticoagulation or systemic corticosteroid treatment, twin or higher order pregnancy, smoker aged >35, inability to understand written English

7

Intervention

- Expectant management No specific intervention
- Medical management PV misoprostol preceded, for women with early fetal demise, by PO mifepristone 24-48 hours earlier
- Surgical management Surgical evacuation

8

Primary end-points

Confimed gynaecological infection at 14 days and 8 weeks

- Definition = 2 or more of purulent discharge, pyrexia >38.0, tenderness over uterus, WCC >15

9

Secondary end-points

Need for unplanned admission or surgical intervention, treatment with Abs for presumed gynaecological infection within 14/7 or 8/52, pain, additional analgesia, vaginal bleeding, days off work, days before return to usual daily activities, fall in Hb, blood transfusion, depression, anxiety

10

Summary of results

- No differences found in incidence of confirmed infection within 14 days between expectant (3%) and surgical (3%) group, or between medical (2%) and surgical group
- Number of unplanned hospital admissions were significantly higher in both the expectant (49%) and medical (18%) group than surgical (8%)
- Number of unplanned surgical curettage was significantly higher in the expectant (44%) and medical (36%) group compared with surgical (5%)
- Cessation of bleeding significantly earlier in surgical group compared with medical group (did not affect Hb)
o But 2% expectant and 1% medical required blood transfusion
- No significant difference in vomiting, diarrhoea, or pain
- Expectant management group required more analgesia
- No significant difference in time on leave, or return to work

11

Limitations

- Unable to blind methods of management
- Lower than expected number of women recruited and took longer than expected
- Success rates of 3 options may be higher than this trial suggests, as women who choose a treatment option are likely to be more motivated to follow their chosen treatment to completion than women who are randomized
- Identified more retained products than you normally would in clinical practice because of routine ultrasound post treatment,