1
scores were particularly useful outcomes. What evidence there was showed little difference between
2
the two treatment arms, but the group felt that these outcomes are often difficult to capture accurately
3
in randomised populations, and are less informative than qualitative data that explores women’s
4
experiences of their mode of management.
5
Consideration of clinical benefits and harms
6
Medical management of miscarriage avoids the need for surgery in over 70% of women. The GDG
7
felt that this would be an important consideration for women, as surgery often requires a general
8
anaesthetic and has an associated risk of complications. The risk of surgical complications among
9
women randomised to surgery ranged from 2% to 8%, and included uterine perforation, haemorrhage,
10
cervical lacerations and synechia. However, medical management is also associated with a
11
significantly higher rate of unplanned intervention and unplanned admission. Gastro-intestinal side
12
effects such as vomiting are higher with medical management of miscarriage but the risk of infection
13
and haemorrhage requiring transfusion is similar for both forms of active management. From their
14
experience the GDG felt that this small risk of blood transfusion may be an over-estimation as in
15
current clinical practice few women receive one.
16
The results of the qualitative studies supported the GDG’s view that individual women often have very
17
different priorities and expectations of their treatment. They recognised that whilst women may
18
strongly wish to avoid undergoing surgery, for some women the predictability, promptness, and high
19
likelihood of success following surgical treatment would be an attractive option. The GDG felt that, as
20
the majority of women would have undergone a week of expectant management as a first line
21
treatment, it was important that they be given a choice about how to proceed at that point. Although
22
the health economics analysis showed that medical management was more cost-effective than
23
surgical management, the GDG noted that this was based on estimates of first-line treatment, and
24
therefore could not directly be applied to women in whom expectant management had already failed.
25
They felt strongly that, after a period of expectant management, women should have the choice of
26
how to proceed, and therefore recommended that a discussion of the options take place.
27
The evidence showed that outcomes such as duration of pain seemed comparable in the medical and
28
surgical arms, although the tendency was that pain lasted longer and was more severe after medical
29
management. Similarly, the duration of bleeding was very variable but generally less in the surgical
30
arm than the medical arm. From their clinical experience, the GDG felt that women’s experiences of
31
pain and bleeding after miscarriage tend to be extremely variable..The GDG noted that medical
32
management of miscarriage seems to be more successful (in terms of avoiding surgical intervention)
33
in women with incomplete or inevitable miscarriage, when compared to those with a missed
34
miscarriage. They also recognised that successful treatment was higher in studies that allowed longer
35
follow-up before surgical intervention and where follow-up was clinical rather than ultrasound
36
orientated. However, due to the differences between the studies, they did not feel that the evidence
37
was strong enough to make a recommendation that might supersede women’s choice. Overall, they
38
noted that there were both advantages, in terms of avoiding surgery, and disadvantages, in terms of
39
the potential for increased pain and bleeding, of medical management and therefore that the
40
individual woman’s preference and specific clinical situation should inform the choice of second-line
41
management strategy.
42
Consideration of health benefits and resource uses
43
Whilst both unplanned admissions and need for an unplanned intervention are higher after medical
44
management of miscarriage compared to surgical treatment, the health economics analysis of first
45
line treatment options calculated that medical management was more cost-effective due to the
46
reduced cost of the initial treatment. However, the GDG felt that, having recommended expectant
47
management (the most cost-effective option) as a first line management strategy on the grounds of
48
cost, it was appropriate that women have options if this strategy failed, particularly as the health
49
economics was based on outcomes of first-line treatment. They noted that, for women in whom
50
expectant management had not been successful, the success of medical management was likely to
51
be reduced, and therefore the associated costs of unplanned interventions and admissions would be
52
increased.
53
Quality of evidence
1
Much of the evidence for this review was of high or moderate quality, and, in particular, the GDG
2
welcomed the inclusion of the MIST trial, a high quality randomised controlled trial conducted in the
3
UK, with an associated qualitative study investigating women’s views of different modes of
4
miscarriage management. The fact that it explored women’s experiences so comprehensively, and
5
was conducted in the UK, led the GDG to believe that it was likely to represent the spectrum of
6
different views that women might have regarding their preferred treatment options. However, as it was
7
only one study involving a small group of women, the GDG felt that it was important to recommend
8
that further research be done to evaluate whether different modes of management impact on patient
9
experience and longer term psychological and emotional outcomes.
10
Information giving and psychological support
11
The GDG noted that an overarching theme from the qualitative data was the fact that women wanted
12
more information about what to expect, what their course of treatment would entail (including potential
13
complications), and what support would be provided (both immediately and longer term). It was noted
14
that a lack of information often led to uncertainty which could heighten women’s anxiety. Therefore,
15
the group felt that it was important that women were informed about the possible course of events
16
following their chosen management course, including what to expect in terms of the duration and
17
severity of bleeding and where and when to get help in an emergency. In addition, it was the
18
experience of some of the group that women are often uncertain about what to expect in the recovery
19
period, and that they therefore need to be given more information about this, including details of how
20
to access counselling and other support services.
21
The GDG also felt it important to support women’s choice following a period of expectant
22
management where this had not been successful. They recognised the potential for increased
23
psychological sequelae if women were denied a choice after 7-14 days of expectant management,
24
during which time they may have been continuing to bleed and desiring a prompt completion of the
25
process.
26
Other considerations
27
Choice of treatment is important for women and satisfaction is higher where women have been
28
offered and exercised their choice. The GDG recognised that for women with greater difficulty in
29
accessing health care (for example, women with English as a second language, drug users,
30
travellers, or those living in a remote area), surgical management might be preferable due to the
31
reduced need for unplanned intervention and unplanned admission. However, they felt that, patient
32
choice was still the most important consideration.
33
Recommendations
34
Number
Recommendation
50 Use expectant management for 7-14 days as the firstline management strategy following confirmed diagnosis of a non-viable pregnancy.
51 Explain expectant management and that most women will need no further treatment. Also provide written and verbal information about further treatment options.
52 Give all women verbal and written information about:
what to expect throughout the process, including the likely duration and severity of bleeding, advice on pain relief and where and when to get help in an emergency
what to expect in the recovery period, such as how long they should wait before resuming sexual activity and trying to conceive.
Ensure that sufficient time is available to discuss these issues with women. Arrange an additional appointment if necessary.