Advise a woman with a confirmed intrauterine pregnancy with a fetal heartbeat who presents with vaginal bleeding, but has no history of previous miscarriage, that:
if her bleeding gets worse, or persists beyond 14 days, she should return for further assessment
if the bleeding stops, she should start or continue routine antenatal care. [2012, amended 2021]
Offer vaginal micronised progesterone 400 mg twice daily to women with an intrauterine pregnancy confirmed by a scan, if they have vaginal bleeding and have previously had a miscarriage. [2021]
If a fetal heartbeat is confirmed, continue progesterone until 16 completed weeks of pregnancy. [2021]
There was good evidence that 400 mg twice daily of micronised vaginal progesterone increases the number of live births in women with early pregnancy bleeding and a previous miscarriage. There was no evidence of benefit for any other preparations or doses of progesterone, so the committee made a recommendation for research on the effectiveness of different progestogens in women at risk of miscarriage.
There was evidence of no benefit in women with early pregnancy bleeding but no previous miscarriage, nor in women with previous miscarriage but no early pregnancy bleeding in the current pregnancy. The committee made a recommendation for research to further assess the use of progesterone in women with recurrent miscarriage. There was no evidence of harm to the mother or baby from the use of progesterone, although the evidence is insufficient to rule out the possibility of rare events.
To reduce the risk of women with a pregnancy of unknown location or an ectopic pregnancy being given progesterone, the committee agreed that, as in the clinical studies, progesterone should only be given to women with intrauterine pregnancy confirmed with a scan. To avoid delay in starting treatment the committee agreed that progesterone could be started before a fetal heartbeat is detected. The evidence on which the recommendations were based had continued the progesterone treatment until 16 weeks of pregnancy so the committee used this duration of treatment in their recommendations.
The committee discussed that as a scan was needed to confirm the intrauterine pregnancy it would be appropriate for the initial prescription for progesterone to be provided by the Early Pregnancy Unit, with prescribing continued to 16 weeks (if a fetal heartbeat was detected) by the woman's GP. However, the committee were aware that shared care prescribing arrangements are usually agreed locally and so did not include this detail in their recommendations.
The committee confirmed that the recommendations for the use of progesterone are only for women with early pregnancy bleeding and a history of miscarriage. The recommendations are not applicable in other circumstances, such as after the use of mifepristone.
Full details of the evidence and the committee's discussion are in evidence review C: progestogens for preventing miscarriage.
The recommendations will increase the use of progestogens to prevent miscarriage but this is cost effective. The recommendations will standardise the preparation of progesterone used to treat threatened miscarriage.
Use expectant management for 7 to 14 days as the first-line management strategy for women with a confirmed diagnosis of miscarriage. Explore management options other than expectant management if:
the woman is at increased risk of haemorrhage (for example, she is in the late first trimester) or
she has previous adverse and/or traumatic experience associated with pregnancy (for example, stillbirth, miscarriage or antepartum haemorrhage) or
she is at increased risk from the effects of haemorrhage (for example, if she has coagulopathies or is unable to have a blood transfusion) or
there is evidence of infection. [2012]
Offer medical management to women with a confirmed diagnosis of miscarriage if expectant management is not acceptable to the woman. [2012]
Explain what expectant management involves and that most women will need no further treatment. Also provide women with oral and written information about further treatment options. [2012]
Give all women undergoing expectant management of miscarriage oral and written information about what to expect throughout the process, advice on pain relief and where and when to get help in an emergency. See also recommendation 1.2.1 for details of further information that should be provided. [2012]
If the resolution of bleeding and pain indicate that the miscarriage has completed during 7 to 14 days of expectant management, provide the woman or person with a urine pregnancy test to carry out at home 3 weeks after their miscarriage, and advise them to return for individualised care if it is positive. [2012, amended 2023]
Offer a repeat scan if after the period of expectant management, the bleeding and pain:
have not started (suggesting that the process of miscarriage has not begun) or
are persisting and/or increasing (suggesting incomplete miscarriage).
Discuss all treatment options (continued expectant management, medical management and surgical management) with the woman to allow her to make an informed choice. [2012]
Review the condition of a woman who opts for continued expectant management of miscarriage at a minimum of 14 days after the first follow‑up appointment. [2012]
There was evidence that the combination of mifepristone and misoprostol reduced the failure of the gestational sac to spontaneously pass by 7 days and reduced the need for surgical intervention to complete the miscarriage up to and after 7 days, compared to misoprostol alone, so the committee recommended a combination treatment.
Time to bleeding was not an outcome reported in the evidence, but the committee noted that the evidence described that bleeding usually started 2 to 3 days after misoprostol treatment, and that study participants were asked to report if bleeding had not started within 48 hours. The committee agreed that 24 hours was too short and so recommended 48 hours as a more realistic timeframe. Based on their knowledge and experience, the committee noted that there may be some people who cannot easily contact early pregnancy services, so it recommended these individuals should be contacted proactively to check that bleeding has begun.
The committee revised the recommendations on incomplete and missed miscarriage to clarify the differences between the treatment of the 2 conditions. The committee reviewed new evidence relating to the use of mifepristone for missed miscarriage and added this to the advice, but agreed that there was no new evidence to support the use of mifepristone for incomplete miscarriage.
The committee agreed, based on their knowledge and experience, that women and people having a miscarriage should also be given advice on when and how to seek help during the miscarriage process, so it added this to the existing advice.
The committee agreed that a positive pregnancy test may indicate the presence of a retained pregnancy, so it added this to the recommendation on when to return for review. Based on expert advice, the committee added additional advice to cover the situation where the pregnancy test is negative but the woman or person is still bleeding or has developed other symptoms.
The committee noted that the recommendation on expectant management of miscarriage stated people should obtain a pregnancy test themselves, whereas the guidance following medical management of miscarriage advised that people should be supplied with a pregnancy test by their care team. To ensure parity of treatment between all groups having a miscarriage, the committee updated this recommendation based on expert opinion and consensus.
Full details of the evidence and the committee's discussion are in evidence review D: medical management of miscarriage.
The recommendation for combination treatment will be a change in practice and women or people being treated for missed miscarriage will now need to receive 2 medications instead of 1, administered 48 hours apart. The use of mifepristone for the treatment of missed miscarriage may also increase. However, as mifepristone is already used in clinical practice for missed miscarriage in many early pregnancy settings this will standardise practice for such settings across the NHS. The use of combination treatment will also reduce the need for surgical intervention so will reduce costs for the NHS. This has been shown to be a cost-effective treatment.
The change from 24 hours to 48 hours in the recommendation on start of bleeding may reduce the number of people contacting early pregnancy services because bleeding has not started. However, the recommendation to proactively follow up with people who do not contact the service may increase resource use, as staff time will be needed to contact these individuals.
This addition of advice on how and when to seek help may increase the number of people seeking help during the miscarriage process, and this may increase resource use for the NHS.
The revised recommendation on positive urine pregnancy tests will not change the number of people who need review after 3 weeks, so there will be no resource impact from this change.
The change to the expectant management advice to give parity of care will increase the number of urine pregnancy tests supplied by the NHS, which will have a resource impact, but this will reduce health inequalities and ensure that all women and people have access to the pregnancy test to complete their management of miscarriage regardless of ability (financial or otherwise) to obtain a pregnancy test themselves.
In August 2023, the use of mifepristone and misoprostol in recommendations 1.11.1 and 1.11.3 was off label. See NICE's information on prescribing medicines.
For the medical management of missed miscarriage offer:
200 mg oral mifepristone and
48 hours later, 800 micrograms misoprostol (vaginal, oral or sublingual) unless the gestational sac has already been passed. [2012, amended 2023]
Advise the woman or person that if bleeding has not started within 48 hours after misoprostol treatment, they should contact their healthcare professional to determine ongoing individualised care. If there are concerns that they will not contact the service then there should be arrangements for the service to follow up with these individuals. [2012, amended 2023]
For the medical management of incomplete miscarriage, use a single dose of misoprostol 600 micrograms (vaginal, oral or sublingual). Misoprostol 800 micrograms can be used as an alternative to allow alignment of treatment protocols for both missed and incomplete miscarriage. [2012, amended 2023]
Do not offer mifepristone as a treatment for incomplete miscarriage. [2012, amended 2023]
Offer all women and people receiving medical management of miscarriage pain relief and anti-emetics as needed. [2012]
Inform women and people receiving medical management of miscarriage about what to expect throughout the process. Include the length and extent of bleeding, potential side effects of treatment including pain, diarrhoea and vomiting, and when and how to seek help. [2012, amended 2023]
Provide women and people who have had medical management of miscarriage with a urine pregnancy test to carry out at home 3 weeks after medical management of miscarriage unless they experience worsening symptoms, in which case advise them to return to the healthcare professional responsible for providing their medical management. [2012, amended 2021]
Advise women and people with a positive urine pregnancy test after 3 weeks to return for a review to the healthcare professional responsible for providing their medical management to rule out a retained pregnancy, molar or ectopic pregnancy, and assess the need for further investigations or treatment. [2012, amended 2023]
If the pregnancy test after 3 weeks is negative but the woman or person is still bleeding heavily or has other symptoms (for example, pelvic pain or fever), then assess the need for further investigations or treatment. [2023]
There was evidence that the combination of mifepristone and misoprostol reduced the failure of the gestational sac to spontaneously pass by 7 days and reduced the need for surgical intervention to complete the miscarriage up to and after 7 days, compared to misoprostol alone, so the committee recommended a combination treatment.
Time to bleeding was not an outcome reported in the evidence, but the committee noted that the evidence described that bleeding usually started 2 to 3 days after misoprostol treatment, and that study participants were asked to report if bleeding had not started within 48 hours. The committee agreed that 24 hours was too short and so recommended 48 hours as a more realistic timeframe. Based on their knowledge and experience, the committee noted that there may be some people who cannot easily contact early pregnancy services, so it recommended these individuals should be contacted proactively to check that bleeding has begun.
The committee revised the recommendations on incomplete and missed miscarriage to clarify the differences between the treatment of the 2 conditions. The committee reviewed new evidence relating to the use of mifepristone for missed miscarriage and added this to the advice, but agreed that there was no new evidence to support the use of mifepristone for incomplete miscarriage.
The committee agreed, based on their knowledge and experience, that women and people having a miscarriage should also be given advice on when and how to seek help during the miscarriage process, so it added this to the existing advice.
The committee agreed that a positive pregnancy test may indicate the presence of a retained pregnancy, so it added this to the recommendation on when to return for review. Based on expert advice, the committee added additional advice to cover the situation where the pregnancy test is negative but the woman or person is still bleeding or has developed other symptoms.
The committee noted that the recommendation on expectant management of miscarriage stated people should obtain a pregnancy test themselves, whereas the guidance following medical management of miscarriage advised that people should be supplied with a pregnancy test by their care team. To ensure parity of treatment between all groups having a miscarriage, the committee updated this recommendation based on expert opinion and consensus.
Full details of the evidence and the committee's discussion are in evidence review D: medical management of miscarriage.
The recommendation for combination treatment will be a change in practice and women or people being treated for missed miscarriage will now need to receive 2 medications instead of 1, administered 48 hours apart. The use of mifepristone for the treatment of missed miscarriage may also increase. However, as mifepristone is already used in clinical practice for missed miscarriage in many early pregnancy settings this will standardise practice for such settings across the NHS. The use of combination treatment will also reduce the need for surgical intervention so will reduce costs for the NHS. This has been shown to be a cost-effective treatment.
The change from 24 hours to 48 hours in the recommendation on start of bleeding may reduce the number of people contacting early pregnancy services because bleeding has not started. However, the recommendation to proactively follow up with people who do not contact the service may increase resource use, as staff time will be needed to contact these individuals.
This addition of advice on how and when to seek help may increase the number of people seeking help during the miscarriage process, and this may increase resource use for the NHS.
The revised recommendation on positive urine pregnancy tests will not change the number of people who need review after 3 weeks, so there will be no resource impact from this change.
The change to the expectant management advice to give parity of care will increase the number of urine pregnancy tests supplied by the NHS, which will have a resource impact, but this will reduce health inequalities and ensure that all women and people have access to the pregnancy test to complete their management of miscarriage regardless of ability (financial or otherwise) to obtain a pregnancy test themselves.
Where clinically appropriate, offer women undergoing a miscarriage a choice of:
manual vacuum aspiration under local anaesthetic in an outpatient or clinic setting or
surgical management in a theatre under general anaesthetic. [2012]
Provide oral and written information to all women undergoing surgical management of miscarriage about the treatment options available and what to expect during and after the procedure. See also recommendation 1.2.1 for details of further information that should be provided. [2012]