Recommendations for research
- 1 Early pregnancy assessment units
- 2 Ultrasound for determining a viable intrauterine pregnancy
- 3 Effectiveness of progestogens in women with recurrent miscarriage
- 4 Effectiveness of different progestogens in women at risk of miscarriage
- 5 Management of miscarriage
- 6 Comparison between expectant, medical or surgical management of ectopic pregnancy
The guideline committee has made the following recommendations for research based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of recommendations for research is detailed in the full guideline.
A national evaluation of early pregnancy assessment unit service provision should be carried out to identify factors affecting outcomes. Factors should include whether care is provided in a dedicated unit, staffing configuration and opening hours of dedicated services. Outcomes should include both process (service) outcomes and pregnancy-related outcomes. Data collected should be used to analyse the cost effectiveness of early pregnancy assessment units compared with other models of care.
The first report of an early pregnancy assessment unit in England was published over 20 years ago, and prompted the rapid development of centres for the management of problems in early pregnancy. Today there are an estimated 150 early pregnancy assessment units in England and Wales (Association of Early Pregnancy Units, 2012). However, there is considerable variation between centres in access to services and levels of care provided. In addition, there has been very little good quality research on the effectiveness of early pregnancy assessment units in improving physical and emotional health compared with services provided outside of a dedicated unit.
A national audit of early pregnancy assessment services would help to make up for this lack of information. Such an audit should be along the lines of the National Caesarean Section Sentinel Audit, a cross-sectional national survey of service configuration and outcomes. Data recorded would include service location, opening hours and the healthcare professionals involved. Outcomes would include time of attendance, length of stay, admission rates, time to treatment and women's experience. Obtaining some of this information would involve early pregnancy services carrying out more formal follow‑up of women than they might do currently, for the duration of the audit. The evaluation should be structured to allow for comparisons between different models of care.
Comparative outcome data collected would be used to conduct an analysis of the cost effectiveness of early pregnancy assessment units compared with other models of care.
How does the timing and frequency of ultrasound examination affect diagnosis and outcomes of early pregnancy complications, including women's experience and cost effectiveness?
The rationale behind the frequency of ultrasound to improve diagnosis and outcomes of early pregnancy complications addresses the problems associated with pregnancy of unknown location and intrauterine pregnancy of uncertain viability. The evidence base for the timing and frequency of scanning in early pregnancy is limited, and the number of scans is organised by individual units according to capacity and demand. Some healthcare professionals choose to wait 5 days between scans whereas others will wait 10 to 14 days. These decisions are driven by resource availability as well as clinical considerations, but in particular the effect of different strategies on cost and women's experience is not clear. The literature suggests that there is no clear consensus, but there is general agreement that by 14 days a diagnosis will be clear. To establish the most appropriate time for scans, the efficacy of scans taken after 14 days could be compared with scans taken after 7 days for diagnosis of ectopic pregnancy or viability.
What is the clinical and cost effectiveness of progesterone for improving outcomes in women with unexplained recurrent miscarriage?
Women with previous pregnancy losses have an increased risk of miscarriage in subsequent pregnancies. Progesterone is essential for maintaining a healthy pregnancy, and there is evidence that it is safe for both women and fetuses.
A recent randomised controlled trial assessed the effectiveness of micronised vaginal progesterone supplementation in women with 3 or more first-trimester losses and did not show a benefit with progesterone therapy use during the first trimester, concluding that there is not enough evidence to support its use in women with unexplained recurrent miscarriage. However, this trial was designed to look for a 10% difference in live birth outcomes in those who received progesterone versus those who did not receive it. A larger randomised controlled trial is needed to determine if there is a smaller difference (for example 2.5% to 5%) which would still lead to a meaningful increase in live births and reduce the trauma of a further miscarriage for a number of women.
What is the clinical and cost effectiveness of vaginal micronised progesterone versus other progesterone preparations in improving outcomes in women at risk of miscarriage?
Evidence from a recent randomised controlled trial showed a small but important benefit for the outcome of live birth when vaginal micronised progesterone was given to women with early pregnancy bleeding and a history of one or more previous miscarriages. However, there was not enough evidence available to assess whether other formulations of progesterone would lead to other beneficial outcomes in this group of women. Research is needed to identify whether there is a difference in the effectiveness of micronised versus non-micronised progesterone therapy in women with early pregnancy bleeding and a history of one or more previous miscarriages.
In women with confirmed miscarriage, does the type of management strategy (expectant, medical and surgical) impact on women's experience, including psychological and emotional outcomes?
The management of miscarriage in the UK has changed in many ways over the past 2 decades, particularly in the shift from inpatient to outpatient or day case care and the introduction of medical and expectant management as alternatives to surgery.
Despite these changes there is a lack of research into the effects of these different approaches from the woman's perspective, in particular their psychological and emotional impact. Miscarriage is distressing for most women, and the type of management itself might affect women's need for counselling, with a resulting cost to the NHS. Because of this it is an important area for research.
The deficiency in the literature could be addressed by a comparative study of women having the different management strategies (expectant, medical or surgical) and in a variety of clinical settings (for example, early pregnancy assessment unit, gynaecological ward or gynaecological emergency unit). The data collected could be both quantitative (using validated psychological health questionnaires) and qualitative (focusing particularly on women's experience of the particular type and setting of care).
In women with ectopic pregnancy, does the type of intervention impact on women's experience, including psychological and emotional outcomes?
Currently there is no evidence exploring the psychological impact of the different treatments for ectopic pregnancy. However, the emotional impact of the condition can be significant, in some circumstances leading to post-traumatic stress disorder. A qualitative comparative study should be carried out to assess how this impact can be reduced. This would help to maximise women's emotional recovery in the short and long term, enable women and clinicians to decide the optimum treatment method and identify what support is needed for women during and after the process. It could also reduce the cost to the NHS of providing long-term counselling for affected women.