Journal
Year
BMJ (published 17 May 2006)
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
Study Design
RCT comparing medical and expectant management with surgical management of first trimester miscarriages
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)
Inclusion Criteria
- Women with pregnancy of <13/40 with either incomplete miscarriage or early fetal/embryonic demise
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
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
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
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
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
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,
