Follow-up after medical abortion up to 10+0 weeks

National Guideline Alliance (UK)

Follow-up after medical abortion up to 10+0 weeks

Abortion care

Evidence review I

NICE Guideline, No. 140

Authors

National Guideline Alliance (UK).

London: National Institute for Health and Care Excellence (NICE); 2019 Sep.

ISBN-13: 978-1-4731-3539-0

Follow-up after medical abortion up to 10⁺⁰ weeks

Review question

What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

Introduction

The aim of this review is to determine the best method of excluding ongoing pregnancy when the expulsion has not been witnessed by healthcare professionals.

At the time of development, the title of this guideline was ‘Termination of pregnancy’ and this term was used throughout the guideline. In response to comments from stakeholders, the title was changed to ‘Abortion care’ and abortion has been used throughout. Therefore, both terms appear in this evidence report.

Summary of the protocol

See Table 1 for a summary of the population, intervention, comparison and outcome (PICO) characteristics of this review.

Table 1

Summary of the protocol (PICO table).

For further details see the full review protocol in appendix A.

Clinical evidence

Included studies

Only studies conducted from 2000 onwards were considered for this review question, because after 2000 clinical practice changed to include the possibility of remote assessment for successful abortion of an early pregnancy when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home).

Six randomised controlled trials were included in this evidence review. Four of these studies compared routine clinic-based follow-up with remote, home-based, self-assessment follow-up after medical abortion (Bracken 2014; Ngoc 2014; Oppegaard 2015; Platais 2015) while the remaining 2 studies compared different methods of remote, home-based self-assessment follow-up (Blum 2016; Constant 2017).

The included studies are summarised in Table 2.

Table 2

Summary of included studies.

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review with reasons for their exclusions are provided in appendix K.

Summary of clinical studies included in the evidence review

A summary of the studies that were included in this review are presented in Table 2.

See the full evidence tables in appendix D and the forest plots in appendix E.

Quality assessment of clinical studies included in the evidence review

See the clinical evidence profiles in appendix F.

Economic evidence

Included studies

A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.

A single economic search was undertaken for all topics included in the scope of this guideline. Please see supplementary material 2 for details.

Excluded studies

No full-text copies of articles were requested for this review and so there is no excluded studies list.

Economic model

No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.

Resource impact

Table 3

Unit costs of pregnancy tests considered.

Evidence statements

Comparison 1. Remote follow-up versus clinic follow-up

Critical outcomes

Missed ongoing pregnancy (failure to detect an ongoing pregnancy)

RCT evidence (n=2935) did not detect a clinically important difference in ‘the rate of missed ongoing pregnancy’ between the remote follow-up group and the clinic-based follow-up group (3 RCTs, n=2935; RR= 4.91; 95% CI 0.58, 41.54; very low quality); however, there was uncertainty around this estimate.

Correct implementation of follow-up strategy (comprehension; i.e., the women understand how to undertake the remote self-assessment protocol)

No evidence was identified to inform this outcome.

Patient satisfaction (prefer remote follow-up for managing abortion follow-up in future)

RCT evidence that could not be meta-analysed due to high heterogeneity (I²=99%; 4 RCTs, n=5060; very low quality) showed a higher clinically important difference in the rates of women who preferred remote follow-up for managing abortion in the future in the women who received remote follow-up compared to the women who received clinic-based follow-up in 3 of the 4 studies (RR=1.4, 95% CI 1.26, 1.55; RR=1.58; 95% CI 1.48, 1.69; and RR=2.22; 95% CI 2.01, 2.45, respectively) whereas there was no clinically important difference in the 4^th study (RR=1.03; 95% CI 0.96, 1.1).

Important outcomes

Adherence to follow-up strategy

RCT evidence that could not be meta-analysed due to high heterogeneity (I²=93%; 3 RCTs, n=4766; very low quality) showed no clinically important difference in ‘the rates of adherence to the follow-up strategy’ between women who received remote or clinic-based follow-up (RR=0.95, 95% CI 0.87, 1.03; RR=0.99; 95% CI 0.98, 1.01; and RR=1.07; 95% CI 1.05, 1.1, respectively).

Unscheduled visits to the abortion service

RCT evidence did not detect a clinically important difference in ‘the rate of unscheduled visits to the abortion service’ between the remote follow-up group and the clinic-based follow-up group (4 RCTs, n=5454; RR= 1.2; 95% CI 0.91, 1.59; low quality); however, there was uncertainty around this estimate.

Unscheduled phone calls to the abortion service

RCT evidence did not detect a clinically important difference in ‘the rate of unscheduled telephone calls to the abortion service’ between the remote follow-up group and the clinic-based follow-up group (1 RCT, n=694; RR= 1.05; 95% CI 0.78, 1.43; very low quality); however, there was uncertainty around this estimate.

Surgical intervention

RCT evidence did not detect a clinically important difference in ‘the rate of surgical intervention’ between the remote follow-up group and the clinic-based follow-up group (4 RCTs, n=5703; RR= 0.93; 95% CI 0.7, 1.23; very low quality); however, there was uncertainty around this estimate.

Comparison 2. Remote follow-up ‘Multi-level pregnancy test’ versus remote follow-up ‘High sensitivity pregnancy test’

Critical outcomes

Missed ongoing pregnancy (failure to detect an ongoing pregnancy)

RCT evidence reported no events of missed ongoing pregnancy in either the multi-level pregnancy test group or the high sensitivity pregnancy test group; therefore difference between groups could not be estimate (1 RCT, n=584; low quality).

Correct implementation of follow-up strategy (comprehension; i.e., the women understand how to undertake the remote self-assessment protocol)

No evidence was identified to inform this outcome.

Patient satisfaction (prefer remote follow-up for managing abortion follow-up in future)

RCT evidence showed no clinically important difference in ‘the rate of women who preferred remote follow-up for managing abortion in the future’ between the multi-level pregnancy test group and the high sensitivity pregnancy test group (1 RCT, n=584; RR=0.97; 95% CI 0.92, 1.03; moderate quality).

Important outcomes

Adherence to follow-up strategy

No evidence was identified to inform this outcome.

Unscheduled visits to the abortion service

RCT evidence showed a lower clinically important difference in ‘the rate of unscheduled visits to the abortion service’ in the multi-level pregnancy test group compared with the high sensitivity pregnancy test group (1 RCT, n=584; RR= 0.09; 95% CI 0.04, 0.22; moderate quality).

Unscheduled phone calls to the abortion service

No evidence was identified to inform this outcome.

Surgical intervention

RCT evidence did not detect a clinically important difference in ‘the rate of surgical intervention’ between the multi-level pregnancy test group and the high sensitivity pregnancy test group (1 RCT, n=584; RR= 0.33; 95% CI 0.01, 8.09; very low quality); however, there was uncertainty around this estimate.

Comparison 3. Remote follow-up ‘Demonstration’ versus remote follow-up ‘Instruction’

Critical outcomes

Missed ongoing pregnancy (failure to detect an ongoing pregnancy)

RCT evidence did not detect a clinically important difference in ‘the rate of missed ongoing pregnancy’ between the Demonstration group and the Instruction group (1 RCT, n=426; RR=2.86; 95% CI 0.12, 69.89; very low quality); however, there was uncertainty around this estimate.

Correct implementation of follow-up strategy (comprehension; i.e., the women understand how to undertake the remote self-assessment protocol)

No evidence was identified to inform this outcome.

Patient satisfaction (prefer remote follow-up for managing abortion follow-up in future)

RCT evidence showed no clinically important difference in ‘the rate of women who preferred remote follow-up for managing abortion in the future’ between the Demonstration group and the Instruction group (1 RCT, n=458; RR=1; 95% CI 0.98, 1.03; moderate quality).

Important outcomes

Adherence to follow-up strategy

No evidence was identified to inform this outcome.

Unscheduled visits to the abortion service

No evidence was identified to inform this outcome.

Unscheduled phone calls to the abortion service

No evidence was identified to inform this outcome.

Surgical intervention

No evidence was identified to inform this outcome.

The committee’s discussion of the evidence

Interpreting the evidence

The outcomes that matter most

Verification of the success of an early medical abortion usually involves a follow-up in-person ultrasound scan. However, women could assess the success of the procedure remotely themselves by following a remote assessment protocol including a urine pregnancy test, provided the remote protocol is as effective and safe as in-person assessment. Missed on-going pregnancy, correct implementation of follow-up strategy and patient satisfaction were therefore selected as critical outcomes. Adherence to follow-up strategy, unscheduled visits or telephone calls to the abortion service and surgical intervention were included as important outcomes due to the impact that needing an unscheduled or second appointment will have on both the woman and on available resources.

The quality of the evidence

The evidence in the pairwise comparisons was assessed using the GRADE methodology. The quality of the evidence across all outcomes ranged from very low to moderate quality and was most often downgraded due to imprecision, inconsistency or design limitations, e.g., 5 of the 6 studies were unblinded.

Benefits and harms

The evidence showed that there were no clinically important differences in the rate of adherence to follow-up strategy between the remote and clinic-based follow-up groups, and that is was unclear whether or not there were clinically important differences between these groups in the rates of missed ongoing pregnancy, unscheduled phone calls or visits to the abortion service or surgical intervention. The evidence also showed that in 3 of the 4 studies the women in the remote follow up groups expressed a clinically important higher rate of preference for remote follow up in a potential future abortion than in the clinic-based groups. When comparing different remote follow-up strategies, the evidence showed that there were no clinically important differences between these comparisons in terms of patient preference, but for both comparisons it was unclear whether or not there was a clinically important difference in the rates of missed ongoing pregnancy, and this was also the case for rates of surgical intervention for the multi-level urine pregnancy test versus a high sensitivity urine pregnancy test comparison. There was, however, a higher clinically important difference in the rate of unscheduled visits to the abortion service in the high-sensitivity urine pregnancy group compared to the multi-level urine pregnancy test group.

The committee noted that both in the evidence and in their experience many women do not return to clinic for their follow-up appointment. A potential benefit of these recommendations is therefore that by giving women both the choice of follow-up method and, in the case of self-assessment and remote follow-up, a pregnancy test, overall more women will receive follow-up. This in turn will help ensure that any unsuccessful medical abortions will have a higher chance of being identified earlier. Moreover, the committee noted that women have to wait longer after the abortion procedure in order to be able to use high sensitivity pregnancy tests because these are not reliable as soon after the abortion as other pregnancy tests. This means that the recommendations will also serve to ensure a quicker resolution of the whole medical abortion intervention. Overall, the committee therefore agreed that the recommendations serve to make abortion services more women-centred by focusing on women’s preference for follow-up method and swift resolution in terms of the assessment of the outcome of the abortion.

As there was sufficient evidence to inform the recommendations, the committee decided to prioritise other areas addressed by the guideline for future research and therefore made no research recommendations regarding the best method of excluding an ongoing pregnancy after early (up to and including 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home).

Cost effectiveness and resource use

A systematic review of the economic literature was conducted but no relevant studies were identified which were applicable to this review question.

The committee considered that there was unlikely to be a significant resource impact from the recommendations made. Any net effect was likely to be cost saving due to fewer clinic visits and fewer ultrasound scans being required for women opting for self-assessment or remote follow-up rather than in-clinic follow-up. Moreover, although low sensitive pregnancy tests are more expensive than high sensitivity pregnancy tests, this difference in price will be offset by fewer clinic visits (and fewer false positive test results) by women who receive the low sensitivity pregnancy test compared to the high sensitivity pregnancy test.

References

Blum 2016
Blum, J., Sheldon, W. R., Ngoc, N. T. N., Winikoff, B., Nga, N. T. B., Martin, R., Van Thanh, L., Blumenthal, P. D., Randomized trial assessing home use of two pregnancy tests for determining early medical abortion outcomes at 3, 7 and 14 days after mifepristone, Contraception, 94, 115–121, 2016 [PubMed: 27067706]
Bracken 2014
Bracken, H., Lohr, P. A., Taylor, J., Morroni, C., Winikoff, B., RU OK? The acceptability and feasibility of remote technologies for follow-up after early medical abortion, Contraception, 90, 29–35, 2014 [PubMed: 24815098]
Constant 2017
Constant, D., Harries, J., Daskilewicz, K., Myer, L., Gemzell-Danielsson, K., Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial, PLoS ONE, 12 (6) (no pagination), 2017 [PMC free article: PMC5480887] [PubMed: 28640845]
Ngoc 2014
Ngoc, N. T. N., Bracken, H., Blum, J., Nga, N. T. B., Minh, N. H., Van Nhang, N., Lynd, K., Winikoff, B., Blumenthal, P. D., Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: A randomized controlled trial, Obstetrics and gynecology, 123, 88–95, 2014 [PubMed: 24463668]
Oppegaard 2015
Oppegaard, K. S., Qvigstad, E., Fiala, C., Heikinheimo, O., Benson, L., Gemzell-Danielsson, K., Clinical follow-up compared with self-assessment of outcome after medical abortion: A multicentre, non-inferiority, randomised, controlled trial, The Lancet, 385, 698–704, 2015 [PubMed: 25468164]
Platais 2015
Platais, I., Tsereteli, T., Comendant, R., Kurbanbekova, D., Winikoff, B., Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan, Contraception, 91, 178–183, 2015 [PubMed: 25497383]

Appendices

Appendix A. Review protocols

Review protocol for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

Table

Women who have had a medical termination of pregnancy (up to 10⁺⁰ weeks of gestation) with mifepristone and misoprostol and expelled the pregnancy at home Exclusions: -No studies with indirect populations

Appendix B. Literature search strategies

Literature search strategy for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

The search for this topic was last run on 19^th November 2018 during the re-runs for this guideline.

Database: Medline & Embase (Multifile)

Last searched on Embase Classic+Embase 1947 to 2018 November 16, Ovid MEDLINE(R) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R) 1946 to November 16, 2018

Date of last search: 19^th November 2018

Database: Cochrane Library via Wiley Online

Date of last search: 19^th November 2018

Appendix C. Clinical evidence study selection

Clinical evidence study selection for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

Figure 1. Study selection flow chart

Appendix D. Clinical evidence tables

Clinical evidence tables for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

Download PDF (429K)

Appendix E. Forest plots

Forest plots for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

Comparison 1. Remote follow-up versus clinic follow-up

Figure 2. Missed ongoing pregnancy

Figure 3. Patient satisfaction (Prefer remote follow up for managing abortion follow up in the future) Not meta-analysed due to high heterogeneity (I² = 99%)

Figure 4. Adherence to follow-up strategy; Not meta-analysed due to high heterogeneity (I² = 93%)

Figure 5. Unscheduled visits to the abortion service

Figure 6. Surgical intervention

Appendix F. GRADE tables

GRADE tables for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

Table 4. Clinical evidence profile: Comparison 1. Remote follow-up versus clinic follow-up

Table 5. Clinical evidence profile: Comparison 2. Remote follow-up ‘Multi-level pregnancy test’ versus remote follow-up ‘High sensitivity pregnancy test’

Table 6. Clinical evidence profile: Comparison 3. Remote follow-up ‘Demonstration’ versus remote follow-up ‘Instruction’

Appendix G. Economic evidence study selection

Economic evidence for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

No economic evidence was identified which was applicable to this review question.

Appendix H. Economic evidence tables

Economic evidence tables for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

No economic evidence was identified which was applicable to this review question.

Appendix I. Economic evidence profiles

Economic evidence profiles for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

No economic evidence was identified which was applicable to this review question.

Appendix J. Health economic analysis

Economic analysis for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home?

No economic analysis was conducted for this review question.

Appendix K. Excluded studies

Excluded studies for review question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

Clinical studies

Table

PICO: population, intervention, comparison and outcomes

Economic studies

No economic evidence was identified for this review. See supplementary material 2 for further information.

Appendix L. Research recommendations

Research recommendations for question: What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical abortion, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?

No research recommendations were made for this review question.

Final

Evidence reviews

These evidence reviews were developed by the National Guideline Alliance hosted by the Royal College of Obstetricians and Gynaecologists

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Bookshelf ID: NBK561071PMID: 32813469

Table 1Summary of the protocol (PICO table)

Population	Women who have had a medical termination of pregnancy (up to 10⁺⁰ weeks of gestation) with mifepristone and misoprostol and expelled the pregnancy at home
Intervention	In-person assessment with an ultrasound scan (not keeping women in to check the expulsion) Remote assessment (e.g., consisting of low sensitivity urine pregnancy test, high sensitivity urine pregnancy test, multilevel urine pregnancy test, serum human chorionic gonadotropin (HCG), and/or self-assessment check lists)
Comparison	In-person assessment versus remote assessment Remote assessment protocol 1 versus remote assessment protocol 2
Outcome	Critical outcomes: Missed ongoing pregnancy (failure to detect an ongoing pregnancy) Correct implementation of follow-up strategy (comprehension; i.e., the women understand how to undertake the remote self-assessment protocol) Patient satisfaction Important outcomes: Adherence to follow-up strategy Unscheduled visits or telephone calls to the termination service Surgical intervention

: HCG: human chorionic gonadotropin

Table 2Summary of included studies

Study and setting

Population

Intervention/ comparison

Outcomes

Blum 2016

Randomised controlled trial

Vietnam

n=600

Literate women seeking early medical abortion with gestational age ≤63 days

Medical abortion: 200mg mifepristone followed by 800micrograms (mcg) buccal misoprostol the next day.

Home-based follow-up: Multilevel pregnancy test at 3, 7 and 14 days after mifepristone.

Home based follow up: High sensitivity pregnancy test at 3, 7 and 14 days after mifepristone.

Missed ongoing pregnancy
Patient satisfaction
Unscheduled visits to the abortion service
Surgical intervention

Bracken 2014

Randomised controlled trial

England

n=999

Women aged 16 years or above requesting a medical abortion using mifepristone and misoprostol for a pregnancy ≤63 days gestation by ultrasound scan

Medical abortion: 200mg oral mifepristone followed by 800mcg vaginal misoprostol 6-72 hours later in the clinic.

Routine clinical follow-up (Clinic): In-clinic US and assessment of outcome of abortion 1 week later. Women in this group were also provided with a high-sensitivity urine pregnancy test to take 3 weeks later and to phone the clinic with the results in case of being unable to attend their in-person visit.

Self-assessment (Remote): Women choose between a telephone call, SMS text message or online questionnaire as their preferred method of remote follow-up, and they were given a low sensitivity pregnancy test to take 2 weeks later when they were also asked a series of questions about potential symptoms via their indicated method.

Missed ongoing pregnancy
Patient satisfaction
Adherence to follow-up strategy
Unscheduled visits to the abortion service
Surgical intervention

Constant 2017

Randomised controlled trial

South Africa

n=525

Women aged 18 years or above, requesting and clinically eligible for medical abortion using mifepristone with home-use of misoprostol of a pregnancy with a gestation up to 63 days.

Medical abortion: 200mg oral mifepristone followed by 800mcg buccal/sublingual misoprostol 24 to 48 hours later.

Home-based follow-up - Demonstration: In-clinic practice of conducting and interpreting (5 min later) a low-sensitivity pregnancy test on own urine sample and interpreted the result at 5 minutes with guidance provided by a study fieldworker using a standardized procedure and pre-scripted instructions. Women then given a symptom checklist and a low sensitivity pregnancy test kit to use on first morning urine 14 days after mifepristone.

Home-based follow-up - Instruction: Same pre-scripted verbal instructions were provided as for Demonstration group, but no practice demonstration. Women then given a symptom checklist and a low-sensitivity pregnancy test kit to use on first morning urine 14 days after mifepristone.

Both group assessed in clinic 2 weeks later.

Missed ongoing pregnancy
Patient satisfaction

Ngoc 2014

Randomised controlled trial

Vietnam

n=1433

Women requesting medical abortion of an intrauterine pregnancy up to 63 days gestation with a working personal phone and no known contraindications to abortion with mifepristone and/or misoprostol, who were able to complete an at-home symptom checklist

Medical abortion: “The most common treatment regimen used for early medical abortion services at the [4] hospitals consists of oral 200 mg mifepristone followed in 24–48 hours by 800micrograms buccal misoprostol administered at home.” (p. 89)

Clinic follow-up (Clinic): Clinic visit 2 weeks after mifepristone administration for a clinical assessment and transvaginal US to confirm the abortion outcome.

Remote follow-up (Remote): A urine-based semi-quantitative pregnancy test, a urine sample cup, an information sheet explaining how to perform and interpret the test, and a questionnaire (which had the woman’s baseline human chorionic gonadotropin (hCG) noted on it) to use at home before a scheduled phone-based follow-up appointment 2 weeks after mifepristone administration.

Missed ongoing pregnancy
Patient satisfaction
Adherence to follow-up strategy
Unscheduled visits to the abortion service
Surgical intervention

Oppegaard 2015

Randomised controlled trial

Austria, Finland, Norway and Sweden

n=929

Women aged 18 years or above requesting a medical abortion of a confirmed evolutive intrauterine pregnancy (visible intrauterine yolk sac or fetal heartbeat on US) of up to 63 days’ gestation.

Medical abortion: 200mg mifepristone followed by 800mcg vaginal misoprostol 24 to 48 hours later at home.

Routine clinical follow-up (Clinic): In-clinic assessment of outcome of abortion 1 to 3 weeks later by a low-sensitivity urine hCG test, measurement of hCG in serum, or ultrasonography.

Self-assessment (Remote): Self-administration of a 2-step urine hCG DUO pregnancy test that has 2 detection thresholds of 5 and 1000IU/L, 1 to 3 weeks after the abortion to assess the outcome. Within 1 month of the initial consultation, the women underwent a telephone consultation with the clinic that aimed to ascertain if there had been expulsion of products of conception and whether the hCG test was negative for either the 1000IU/L or 5IU/L concentrations.

Missed ongoing pregnancy
Patient satisfaction
Unscheduled visits or telephone calls to the abortion service
Surgical intervention

Platais 2015

Randomised controlled trial

Moldova and Uzbekistan

n=2400

Women requesting medical abortion of pregnancies ≤63 days’ gestation with no known contraindications to mifepristone and/or misoprostol.

Medical abortion: 200mg oral mifepristone followed by 400mcg sublingual misoprostol 24 to 48 hours later.

Clinic follow-up (Clinic): Clinic-based follow-up 2 weeks after mifepristone administration assessing the abortion outcome by clinical examination, women’s report of symptoms, and ultrasound, if needed.

Remote follow-up (Remote): A semi-quantitative pregnancy test and a symptom checklist questionnaire to use at home before a scheduled phone-based follow-up appointment 2 weeks after mifepristone administration.

Patient satisfaction
Adherence to follow-up strategy
Unscheduled visits to the abortion service
Surgical intervention

: hCG: human chorionic gonadotrophin; mcg: micrograms; US: ultrasound

Table 3Unit costs of pregnancy tests considered

Resource	Unit costs	Source
High Sensitivity pregnancy Test Kit¹	£0.74	NHS Supply Chain 2017
Low Sensitivity Pregnancy Test Kit²	£2.19	NHS Supply Chain 2017
Nurses Time (5 minutes)²	£3.08	PSSRU 2018

1: Mean cost of all reported high sensitivity pregnancy tests

2: Mean cost of all reported low sensitivity pregnancy tests

3: Band 5 Nurse excluding qualification costs

Field (based on PRISMA-P	Content
Review question in SCOPE	What is the best method of excluding an ongoing pregnancy after early (up to 10 weeks) medical termination of pregnancy, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?
Review question in guideline	What is the best method of excluding an ongoing pregnancy after early (up to 10⁺⁰ weeks) medical termination of pregnancy, when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?
Type of review question	Intervention
Objective of the review	To determine the best method of excluding ongoing pregnancy when the expulsion has not been witnessed by healthcare professionals.
Eligibility criteria – population	Women who have had a medical termination of pregnancy (up to 10⁺⁰ weeks of gestation) with mifepristone and misoprostol and expelled the pregnancy at home Exclusions: - No studies with indirect populations
Eligibility criteria – intervention(s)	In-person assessment with an ultrasound scan (not keeping in women to check the expulsion) 2. Remote assessment (e.g., consisting of low sensitivity urine pregnancy test, high sensitivity urine pregnancy test, multilevel urine pregnancy test, serum human chorionic gonadotropin (HCG), and/or self-assessment check lists)
Eligibility criteria – comparator(s)	The following comparisons will be considered: In-person assessment versus remote assessment Remote assessment protocol 1 versus remote assessment protocol 2
Outcomes and prioritisation	Critical outcomes: Missed ongoing pregnancy (failure to detect an ongoing pregnancy) Correct implementation of follow-up strategy (comprehension; i.e., the women understand how to undertake the remote self-assessment protocol) Patient satisfaction Important outcomes: Adherence to follow-up strategy Unscheduled visits or telephone calls to the termination service Surgical intervention
Eligibility criteria – study design	- Systematic reviews of RCTs - RCTs
Other inclusion exclusion criteria	Inclusion: - English-language
Proposed sensitivity/sub-group analysis, or meta-regression	Stratified analyses based on the following sub-groups of women, where possible: Medical conditions: - Complex pre-existing medical conditions - No complex pre-existing medical conditions English speaking versus non-English speaking Age <18 or ≥18 years
Selection process – duplicate screening/selection/analysis	Dual sifting will be undertaken for this question using NGA STAR software, with resolution of discrepancies in discussion with the senior reviewer if necessary. Sifting, data extraction, appraisal of methodological quality and GRADE assessment will be performed by the systematic reviewer. Quality control will be performed by the senior systematic reviewer. Dual data extraction will not be performed for this question.
Data management (software)	Pairwise meta-analyses of RCT data will be performed using Cochrane Review Manager (RevMan5). ‘GRADEpro’ will be used to assess the quality of evidence for each outcome. NGA STAR software will be used for study sifting, data extraction, recording quality assessment using checklists and generating bibliographies/citations,
Information sources – databases and dates	Sources to be searched: Medline, Medline In-Process, CCTR, CDSR, DARE, HTA, Embase Limits (e.g. date, study design): Apply standard animal/non-English language exclusion Dates: 2000 onwards A date limit of 2000 will be applied because after 2000 clinical practice changed to include the possibility of remote assessment for successful termination of an early pregnancy when the expulsion has not been witnessed by healthcare professionals (for example, expulsion at home)?
Identify if an update	Not an update
Author contacts	For details please see the guideline in development web site
Highlight if amendment to previous protocol	For details please see section 4.5 of Developing NICE guidelines: the manual
Search strategy – for one database	For details please see appendix B
Data collection process – forms/duplicate	A standardised evidence table format will be used, and published as appendix D (clinical evidence tables) or H (economic evidence tables)
Data items – define all variables to be collected	For details please see evidence tables in appendix D (clinical evidence tables) or H (economic evidence tables)
Methods for assessing bias at outcome/study level	Standard study checklists will be used to critically appraise individual studies. For details please see section 6.2 of Developing NICE guidelines: the manual Appraisal of methodological quality: The methodological quality of each study will be assessed using an appropriate checklist: Cochrane risk of bias tool for RCTs The risk of bias across all available evidence will be evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group http://www.gradeworkinggroup.org/
Criteria for quantitative synthesis (where suitable)	For details please see section 6.4 of Developing NICE guidelines: the manual
Methods for analysis – combining studies and exploring (in)consistency	Synthesis of data: Pairwise meta-analysis will be conducted where appropriate for all outcomes. When meta-analysing continuous data, change scores will be pooled in preference to final scores. For details regarding inconsistency, please see the methods chapter Minimally important differences: Default values will be used of: 0.8 and 1.25 for dichotomous outcomes (relative risks); 0.5 times SD (of control group) for continuous outcomes.
Meta-bias assessment – publication bias, selective reporting bias	For details please see section 6.2 of Developing NICE guidelines: the manual. If sufficient relevant RCT evidence is available, publication bias will be explored using RevMan software to examine funnel plots.
Assessment of confidence in cumulative evidence	For details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual
Rationale/context – Current management	For details please see the introduction to the evidence review
Describe contributions of authors and guarantor	A multidisciplinary committee developed the guideline. The committee was convened by The National Guideline Alliance and chaired by Profession Iain Cameron in line with section 3 of Developing NICE guidelines: the manual. Staff from The National Guideline Alliance will undertake systematic literature searches, appraise the evidence, conduct meta-analysis and cost-effectiveness analysis where appropriate, and draft the guideline in collaboration with the committee. For details please see the methods chapter
Sources of funding/support	The National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists
Name of sponsor	The National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists
Roles of sponsor	NICE funds The National Guideline Alliance to develop guidelines for those working in the NHS, public health, and social care in England
PROSPERO registration number	Not registered

: GRADE: Grading of Recommendations Assessment, Development and Evaluation; HCG: human chorionic gonadotropin; NHS: National Health Service; NICE: National Institute for Health and Care Excellence; NGA: National Guideline Alliance; RCT: randomised controlled trial; SD: standard deviation;

Date of last search: 19^th November 2018

#	Searches
1	exp abortion/ use emczd
2	exp pregnancy termination/ use emczd
3	exp Abortion, Induced/ use ppez
4	Abortion Applicants/ use ppez
5	exp Abortion, Spontaneous/ use ppez
6	exp Abortion, Criminal/ use ppez
7	Aborted fetus/ use ppez
8	fetus death/ use emczd
9	abortion.mp.
10	(abort$ or postabort$ or preabort$).tw.
11	((f?etal$ or f?etus$ or gestat$ or midtrimester$ or pregnan$ or prenatal$ or pre natal$ or trimester$) and terminat$).tw.
12	((f?etal$ or f?etus$) adj loss$).tw.
13	((gestat$ or midtrimester$ or pregnan$ or prenatal$ or pre natal$ or trimester$) adj3 loss$).tw.
14	(((elective$ or threaten$ or voluntar$) adj3 interrupt$) and pregnan$).tw.
15	1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14
16	exp Pregnancy Tests/ use ppez
17	exp pregnancy test/ use emczd
18	((pregnan$ or LSPT or MSPT or HSPT or MLPT or HLPT or LSUP or MSUP or HSUP) adj test$).tw.
19	Self-Assessment/ use ppez
20	self evaluation/ use emczd
21	*Self Report/ use ppez
22	*self report/ use emczd
23	Checklist/ use ppez
24	checklist/ use emczd
25	((self-assess$ or selfassess$ or self assess$ or self-evaluat$ or selfevaluat$ or self evaluat$) adj3 (success or outcome$ or complet$ or home or remote)).tw.
26	checklist$.tw.
27	exp Chorionic Gonadotropin/ use ppez
28	chorionic gonadotropin/ use emczd
29	((beta-hcg$ or hcg$) adj (test$ or level$ or measurement$)).tw.
30	exp Telemedicine/ use ppez
31	exp telemedicine/ use emczd
32	(telemed$ or teleconsult$).tw.
33	Self Administration/ use ppez
34	drug self administration/ use emczd
35	(exp home/ or home care/) use emczd
36	home monitoring/ use emczd
37	follow up/ use emczd
38	((follow-up or followup or follow up) adj (care or model$ or procedure$)).tw.
39	((simple$ or standard$ or traditional$ or mToP) adj (follow-up or followup or follow up)).tw.
40	((in-person$ or in-clinic$ or in-office$ or remote$ or telephone$ or ultrasound$ or ultrasonograph$ or sonogra$ or endosonogra$) adj3 (follow-up or followup or follow up or assess$)).tw.
41	16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40
42	15 and 41
43	(controlled clinical trial or pragmatic clinical trial or randomized controlled trial).pt. or drug therapy.fs. or (groups or placebo or randomi#ed or randomly or trial).ab.
44	crossover procedure/ or double blind procedure/ or randomized controlled trial/ or single blind procedure/ or (assign* or allocat* or crossover* or cross over* or ((doubl* or singl) adj blind) or factorial* or placebo* or random* or volunteer*).ti,ab.
45	meta-analysis/
46	meta-analysis as topic/
47	systematic review/
48	meta-analysis/
49	(meta analy* or metanaly* or metaanaly*).ti,ab.
50	((systematic or evidence) adj2 (review* or overview*)).ti,ab.
51	((systematic* or evidence) adj2 (review or overview*)).ti,ab.
52	(reference list* or bibliograph* or hand search* or manual search* or relevant journals).ab.
53	(search strategy or search criteria or systematic search or study selection or data extraction).ab.
54	(search* adj4 literature).ab.
55	(medline or pubmed or cochrane or embase or psychlit or psyclit or psychinfo or psycinfo or cinahl or science citation index or bids or cancerlit).ab.
56	cochrane.jw.
57	((pool* or combined) adj2 (data or trials or studies or results)).ab.
58	letter/
59	editorial/
60	news/
61	exp historical article/
62	Anecdotes as Topic/
63	comment/
64	case report/
65	(letter or comment*).ti.
66	58 or 59 or 60 or 61 or 62 or 63 or 64 or 65
67	randomized controlled trial/ or random*.ti,ab.
68	66 not 67
69	animals/ not humans/
70	exp Animals, Laboratory/
71	exp Animal Experimentation/
72	exp Models, Animal/
73	exp Rodentia/
74	(rat or rats or mouse or mice).ti.
75	68 or 69 or 70 or 71 or 72 or 73 or 74
76	letter.pt. or letter/
77	note.pt.
78	editorial.pt.
79	case report/ or case study/
80	(letter or comment*).ti.
81	76 or 77 or 78 or 79 or 80
82	randomized controlled trial/ or random*.ti,ab.
83	81 not 82
84	animal/ not human/
85	nonhuman/
86	exp Animal Experiment/
87	exp Experimental Animal/
88	animal model/
89	exp Rodent/
90	(rat or rats or mouse or mice).ti.
91	83 or 84 or 85 or 86 or 87 or 88 or 89 or 90
92	75 use ppez
93	91 use emczd
94	92 or 93
95	43 use ppez
96	44 use emczd
97	95 or 96
98	(or/45-46,49,51-56) use ppez
99	(or/47-50,52-57) use emczd
100	98 or 99
101	42 and 94
102	42 not 101
103	97 or 100
104	102 and 103
105	limit 104 to english language
106	limit 105 to yr="2000 -Current”
107	remove duplicates from 106

Date of last search: 19^th November 2018

#	Searches
#1	MeSH descriptor: [Abortion, Induced] explode all trees
#2	MeSH descriptor: [Abortion Applicants] explode all trees
#3	MeSH descriptor: [Abortion, Spontaneous] explode all trees
#4	MeSH descriptor: [Abortion, Criminal] explode all trees
#5	MeSH descriptor: [Aborted Fetus] explode all trees
#6	“abortion":ti,ab,kw (Word variations have been searched)
#7	(abort* or postabort* or preabort*):ti,ab,kw (Word variations have been searched)
#8	((fetal* or fetus* or foetal* or foetus* or gestat* or midtrimester* or pregnan* or prenatal* or pre natal* or trimester) and terminat):ti,ab,kw (Word variations have been searched)
#9	((fetal* or fetus* or foetal* or foetus) next loss):ti,ab,kw (Word variations have been searched)
#10	((gestat* or midtrimester* or pregnan* or prenatal* or pre natal* or trimester) near/3 loss):ti,ab,kw (Word variations have been searched)
#11	(((elective* or threaten* or voluntar) near/3 interrupt) and pregnan*):ti,ab,kw (Word variations have been searched)
#12	#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11
#13	MeSH descriptor: [Pregnancy Tests] explode all trees
#14	((pregnan* or LSPT or MSPT or HSPT or MLPT or HLPT or LSUP or MSUP or HSUP) next test*):ti,ab,kw (Word variations have been searched)
#15	MeSH descriptor: [Self-Assessment] this term only
#16	MeSH descriptor: [Self Report] this term only
#17	MeSH descriptor: [Checklist] this term only
#18	((self-assess* or selfassess* or self assess* or self-evaluat* or selfevaluat* or self evaluat) near/3 (success or outcome or complet* or home or remote)):ti,ab,kw (Word variations have been searched)
#19	checklist*:ti,ab,kw (Word variations have been searched)
#20	MeSH descriptor: [Chorionic Gonadotropin] explode all trees
#21	((beta-hcg* or hcg) next (test or level* or measurement*)):ti,ab,kw (Word variations have been searched)
#22	MeSH descriptor: [Telemedicine] explode all trees
#23	(telemed* or teleconsult*):ti,ab,kw (Word variations have been searched)
#24	MeSH descriptor: [Self Administration] this term only
#25	((follow-up or followup or follow up) next (care or model* or procedure*)):ti,ab,kw (Word variations have been searched)
#26	((simple* or standard* or traditional* or mToP) next (follow-up or followup or follow up)):ti,ab,kw (Word variations have been searched)
#27	((in-person* or in-clinic* or in-office* or remote* or telephone* or ultrasound* or ultrasonograph* or sonogra* or endosonogra) near/3 (follow-up or followup or follow up or assess)):ti,ab,kw (Word variations have been searched)
#28	#13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27
#29	#12 and #28

Figure 1Study selection flow chart

Figure 2Missed ongoing pregnancy

Figure 3Patient satisfaction (Prefer remote follow up for managing abortion follow up in the future) Not meta-analysed due to high heterogeneity (I² = 99%)

(1) High proportion of missing data, but sensitivity analyses showed that if all the missing data were preference for assigned method [Clinic: 333/466; Remote: 400/458] or preference for non-assigned method [Clinic: 190/466; Remote: 272/458], the results still favoured statistically significantly remote assessment.

Figure 4. Adherence to follow-up strategy; Not meta-analysed due to high heterogeneity (I2 = 93%).

Figure 4Adherence to follow-up strategy; Not meta-analysed due to high heterogeneity (I² = 93%)

Figure 5Unscheduled visits to the abortion service

Figure 6Surgical intervention

(2) Surgical intervention for ongoing pregnancy, evacuation of retained products of conception, incomplete or missed abortion, heavy bleeding, or requested by the woman

Table 4Clinical evidence profile: Comparison 1. Remote follow-up versus clinic follow-up

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Remote follow up	Clinic follow-up	Relative (95% CI)	Absolute	Quality	Importance
Missed ongoing pregnancy (follow-up 2-13 weeks)
3 (Bracken 2014; Ngoc 2014; Oppegaard 2015)	Randomised trials	Serious¹	No serious inconsistency	No serious indirectness²	Very serious³	None	4/1481 (0.27%)	0/1454 (0%)	RR 4.91 (0.58 to 41.54)	Not estimable	VERY LOW	CRITICAL
Patient satisfaction (Prefer remote follow-up for managing abortion follow-up in future) (follow-up 2-13 weeks) Not meta-analysed due to high heterogeneity
4 (Bracken 2014; Ngoc 2014; Oppegaard 2015; Platais 2015)	Randomised trials	Serious¹	Very serious⁴	Serious⁵	No serious imprecision⁶	None	Bracken 2014: 277/326 (84.97%)	Bracken 2014: 294/355 (82.82%)	RR 1.03 (0.96 to 1.1)	25 more per 1000 (from 33 fewer to 83 more)	VERY LOW	CRITICAL
							Ngoc 2014: 606/686 (88.34%)	Ngoc 2014: 256/642 (39.88%)	RR 2.22 (2.01 to 2.45)	486 more per 1000 (from 403 more to 578 more)
							Oppegaard 2015: 272/330 (82.42%)	Oppegaard 2015: 190/323 (58.82%)	RR 1.4 (1.26 to 1.55)	235 more per 1000 (from 153 more to 324 more)
							Platais 2015: 913/1199 (76.15%)	Platais 2015: 577/1199 (48.12%)	RR 1.58 (1.48 to 1.69)	279 more per 1000 (from 231 more to 332 more)
Adherence to follow-up strategy (follow-up 2-3 weeks) Not meta-analysed due to high heterogeneity
3 (Bracken 2014; Ngoc 2014; Platais 2015)	Randomised trials	No serious risk of bias	Very serious⁷	Serious⁸	No serious imprecision	None	Bracken 2014: 322/469 (68.66%)	Bracken 2014: 337/464 (72.63%)	RR 0.95 (0.87 to 1.03)	36 fewer per 1000 (from 94 fewer to 22 more)	VERY LOW	IMPORTANT
							Ngoc 2014: 693/713 (97.19%)	Ngoc 2014: 652/720 (90.56%)	RR 1.07 (1.05 to 1.1)	63 more per 1000 (from 45 more to 91 more)
							Platais 2015: 1163/1200 (96.92%)	Platais 2015: 1170/1200 (97.5%)	RR 0.99 (0.98 to 1.01)	10 fewer per 1000 (from 19 fewer to 10 more)
Unscheduled visits to the termination service (follow-up 2-13 weeks)
4 (Bracken 2014; Ngoc 2014; Oppegaard 2015; Platais 2015)	Randomised trials	Serious⁹	No serious inconsistency	No serious indirectness	Serious¹⁰	None	106/2726 (3.9%)	88/2728 (3.2%)	RR 1.2 (0.91 to 1.59)	6 more per 1000 (from 3 fewer to 19 more)	LOW	IMPORTANT
Unscheduled telephone calls to the termination service (follow-up 13 weeks)
1 (Oppegaard 2015)	Randomised trials	Serious¹¹	No serious inconsistency	No serious indirectness	Very serious³	None	68/346 (19.7%)	65/348 (18.7%)	RR 1.05 (0.78 to 1.43)	9 more per 1000 (from 41 fewer to 80 more)	VERY LOW	IMPORTANT
Surgical intervention (follow-up 2-13 weeks)
4 (Bracken 2014; Ngoc 2014; Oppegaard 2015; Platais 2015)	Randomised trials	Serious⁹	No serious inconsistency	Serious⁵	Serious¹⁰	None	91/2837 (3.2%)	99/2866 (3.5%)	RR 0.93 (0.7 to 1.23)	2 fewer per 1000 (from 10 fewer to 8 more)	VERY LOW	IMPORTANT

: CI: confidence interval; MID: minimally important difference; RR: relative risk

1: All the studies were unblinded, and in one of them there was high risk of attrition bias.

2: In one of the studies, it was unclear how many women received ultrasound as part of the follow-up in the clinic follow-up group.

3: The 95% CI crosses two MID thresholds.

4: Very high heterogeneity (I² = 99%)

5: In two of the studies, it was unclear how many women received ultrasound as part of the follow-up in the clinic follow-up group. Moreover, the outcome itself is indirect and is only reported because none of the studies reported the target outcome of patient satisfaction.

6: The results are not downgraded for imprecision as they have already been downgraded two levels for inconsistency and they are in agreement that women either prefer remote follow-up (Ngoc 2014, Oppegaard 2015 and Platais 2015) or that there is no difference between their preference for remote or clinic follow-up (Bracken 2014)

7: Very high heterogeneity (I² = 93%)

8: In the largest study (Platais 2015), it was unclear how many women received ultrasound as part of the follow-up in the clinic follow-up group.

9: All the studies were unblinded.

10: The 95% CI crosses one MID threshold

11: The study was unblinded.

Table 5Clinical evidence profile: Comparison 2. Remote follow-up ‘Multi-level pregnancy test’ versus remote follow-up ‘High sensitivity pregnancy test’

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Multi-level pregnancy test	High sensitivity pregnancy test	Relative (95% CI)	Absolute	Quality	Importance
Missed ongoing pregnancy (follow-up 2 weeks)
1 (Blum 2016)	Randomised trials	No serious risk of bias	No serious inconsistency	No serious indirectness	Very serious¹	None	0/293 (0%)	0/291 (0%)	Not estimable	Not estimable	LOW	CRITICAL
Patient satisfaction (Prefer remote follow-up for managing abortion follow-up in future) (follow-up 2 weeks)
1 (Blum 2016)	Randomised trials	Serious²	No serious inconsistency	Serious indirectness³	No serious imprecision	None	257/293 (87.7%)	263/291 (90.4%)	RR 0.97 (0.92 to 1.03)	27 fewer per 1000 (from 72 fewer to 27 more)	MODERATE	CRITICAL
Unscheduled visits to the termination service (follow-up 2 weeks)
1 (Blum 2016)	Randomised trials	Serious²	No serious inconsistency	No serious indirectness	No serious imprecision	None	5/293 (1.7%)	56/291 (19.2%)	RR 0.09 (0.04 to 0.22)	175 fewer per 1000 (from 150 fewer to 185 fewer)	MODERATE	IMPORTANT
Surgical intervention (follow-up 2 weeks)
1 (Blum 2016)	Randomised trials	Serious²	No serious inconsistency	No serious indirectness	Very serious⁴	None	0/293 (0%)	1/291 (0.34%)	RR 0.33 (0.01 to 8.09)	2 fewer per 1000 (from 3 fewer to 24 more)	VERY LOW	IMPORTANT

: CI: confidence interval; MID: minimally important difference; RR: relative risk

1: The study is not powered to detect this outcome.

2: The study was unblinded.

3: The outcome itself is indirect and is only reported because the study reported the target outcome of patient satisfaction.

4: The 95% CI crosses two MID thresholds.

Table 6Clinical evidence profile: Comparison 3. Remote follow-up ‘Demonstration’ versus remote follow-up ‘Instruction’

Quality assessment							No of patients		Effect		Quality	Importance
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Demonstration	Instruction	Relative (95% CI)	Absolute	Quality	Importance
Missed ongoing pregnancy (follow-up 2-4 weeks)
1 (Constant 2017)	Randomised trials	Serious¹	No serious inconsistency	No serious indirectness	Very serious²	None	1/218 (0.46%)	0/208 (0%)	RR 2.86 (0.12 to 69.89)	Not estimable	VERY LOW	CRITICAL
Patient satisfaction (Prefer remote follow-up for managing abortion follow-up in future) (follow-up 2-4 weeks)
1 (Constant 2017)	Randomised trials	Serious³	No serious inconsistency	Serious indirectness⁴	No serious imprecision	None	228/231 (98.7%)	223/227 (98.2%)	RR 1 (0.98 to 1.03)	0 fewer per 1000 (from 20 fewer to 29 more)	LOW	CRITICAL

: CI: confidence interval; MID: minimally important difference; RR: relative risk

1: High risk of attrition bias.

2: The 95% CI crosses two MID thresholds.

3: High risk of attrition bias and only the clinic staff, not the women or the field workers, were blinded.

4: The outcome itself is indirect and is only reported because the study reported the target outcome of patient satisfaction.

Study	Reason for Exclusion
Clark,W., Bracken,H., Tanenhaus,J., Schweikert,S., Lichtenberg,E.S., Winikoff,B., Alternatives to a routine follow-up visit for early medical abortion, Obstetrics and Gynecology, 115, 264-272, 2010	Non-randomised trial
Constant, D., Daskilewicz, K., Harries, J., Myer, L., Gemzell-Danielsson, K., Instruction-only versus demonstration of a low sensitivity pregnancy test for self-assessment of medical abortion in South Africa; a multicentre non-inferiority randomised controlled trial, European Journal of Contraception and Reproductive Health Care, 21, 52-53, 2016	Conference abstract only - full text available
Constant, D., Daskilewicz, K., Harries, J., Myer, L., Gemzell-Danielsson, K., Self-assessment of medical abortion using a low-sensitivity pregnancy test, checklist and text messages in the South African public sector: A randomized controlled trial, Contraception, 92 (4), 373, 2015	Conference abstract only - full text available
Constant, D., de Tolly, K., Harries, J., Myer, L., Assessment of completion of early medical abortion using a text questionnaire on mobile phones compared to a self-administered paper questionnaire among women attending four clinics, Cape Town, South Africa, Reproductive Health Matters, Part S1. 22, 83-93, 2015	All women received in-person assessment; randomisation was to standard care versus standard care and text questionnaire
Dabash, R., Shochet, T., Hajri, S., Chelli, H., Hassairi, A. E., Haleb, D., Labassi, H., Sfar, E., Temimi, F., Koenig, L., Winikoff, B., Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia, BMC Women’s Health, 16 (1) (no pagination), 2016	Non-randomised trial
de Tolly, K. M., Constant, D., Integrating mobile phones into medical abortion provision: intervention development, use, and lessons learned from a randomized controlled trial, JMIR MHealth and UHealthJMIR Mhealth Uhealth, 2, e5, 2014	Results of the randomised component of the trial not reported in this paper (reported in Constant 2017)
Debby,A., Malinger,G., Harow,E., Golan,A., Glezerman,M., Transvaginal ultrasound after first-trimester uterine evacuation reduces the incidence of retained products of conception, Ultrasound in Obstetrics and Gynecology, 27, 61-64, 2006	Population inconsistent with protocol: surgical abortion
Godfrey, E. M., Anderson, A., Fielding, S. L., Meyn, L., Creinin, M. D., Clinical utility of urine pregnancy assays to determine medical abortion outcome is limited, Contraception, 75, 378-382, 2007	Women received all methods of assessment for ongoing pregnancy; this component of the trial was not randomised
Grossman, D., Grindlay, K., Alternatives to ultrasound for follow-up after medication abortion: A systematic review, Contraception, 83, 504-510, 2011	Non-randomised trials
Iyengar, K., Paul, M., Iyengar, S. D., Klingberg-Allvin, M., Essen, B., Bring, J., Soni, S., Gemzell-Danielsson, K., Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: A randomised, controlled, non-inferiority trial, The Lancet Global Health, 3, 2015	In-person assessment did not use ultrasound
Nct,, Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion, Https://clinicaltrials.gov/show/nct03440866, 2018	Comparison not in PICO
Ortiz, J., Post-abortion follow-up through SMS: Texting alternatives to unnecessary follow-up visits, International Journal of Gynecology and Obstetrics, 143 (Supplement 3), 54, 2018	Published as abstract only, not enough information available to ascertain relevance
Paul, M., Iyengar, K., Essen, B., Gemzell-Danielsson, K., Iyengar, S. D., Bring, J., Soni, S., Klingberg-Allvin, M., Acceptability of home-assessment post medical abortion and medical abortion in a low-resource setting in Rajasthan, India. Secondary outcome analysis of a non-inferiority randomized controlled trial, PloS one, 10 (9) (no pagination), 2015	In-person assessment did not use ultrasound
Raymond, E. G., Shochet, T., Blum, J., Sheldon, W. R., Platais, I., Bracken, H., Dabash, R., Weaver, M. A., Ngoc, N. T. N., Blumenthal, P. D., Winikoff, B., Serial multilevel urine pregnancy testing to assess medical abortion outcome: a meta-analysis, Contraception, 95, 442-448, 2017	Includes non-randomised trials; no new studies identified
Raymond, E. G., Shochet, T., Bracken, H., Low-sensitivity urine pregnancy testing to assess medical abortion outcome: A systematic review, Contraception., 2018	Includes non-randomised trials; no new studies identified

: PICO: population, intervention, comparison and outcomes

Follow-up after medical abortion up to 10+0 weeks

Authors