In November 2018, the Royal College of Obstetricians and Gynaecologists (Great Britain) published a study into the safety and acceptability of medical abortion through telemedicine provided by Women on Web in Poland.
This study noted: a lack of certainty in the self-reporting of gestational age; an increasing need for surgical intervention as GA increased; and women often reporting their rate of bleeding and level of pain was higher than expected.
The study is important because Women on Web are one of the service providers often recommended to women living in Northern Ireland.
This was a cohort study of 615 women living in Poland who had requested and proceeded with a medical abortion through telemedicine with Women on Web, during the period June 1st to December 31st, 2016.
The study was published online on November 19, 2018.
The objective was to assess the safety and acceptability of abortion through telemedicine at >9 weeks gestational age, (GA is measured from the first day of a woman’s last menstrual period). This is in the context of WHO and FDA guidelines which, at the time of this study, limited the self-administration of misoprostol by women at home to GA of 9 and 10 weeks, respectively.
The key findings noted by the authors, who include the founder of Women on Web, are that neither safety nor acceptability are affected by the increase in GA at the time of self-administration of the abortion pills, but there is an association for GA >9 with a four-fold higher risk of clinical visits by women and this risk continues to increase as their GA increases; more than one-in-eight women with GA >9 weeks made such a visit.
Other results worth noting for further investigation include:
- Even at ≤9 weeks GA, 45% of women reported that their rate of bleeding was higher than expected, increasing to 57% for those women >9 GA.
- One-third of all women, regardless of GA, reported that their rate of pain was higher than expected.
- Both above, might indicate a weakness in the guidance and information provided during the consultation and pre-counselling.
- The rate of surgical intervention needed to complete the abortion was much higher than expected. In the ≤9 weeks GA group this rate was 8.6% compared to a predicted 3%. For >9, the rate was 14.9% compared to a predicted 7%. One-in-nine women taking the abortion pills at home needed a surgical intervention to complete their abortion.
- There was a high rate for lost-to-follow-up, LTFU, was 35%.
- The authors noted some uncertainty about the self-reporting of gestational age.
- Provider organisations should carefully evaluate the clarity and effectiveness of the advice and guidance which they provide to women, and how well this prepares women for self-administration and self-management of the abortion process.
Abortion law in Poland.
Abortion access is restricted by law in Poland; the authors estimate these laws prohibit the termination of unwanted pregnancies in 97% of cases, allowing the procedure only in case of severe danger to the life of the woman or fetus, or if the pregnancy results from a criminal act, such as rape or incest. WoW, and others, consider telemedicine abortion services as an essential means of overcoming the lack of access to safe abortion in many countries. They provide online consultation and guidance and send the abortion medication by post to women who otherwise would resort to less safe, or even unsafe, methods.
Higher Risk of Hospital Visits.
The authors conclude that medical abortion through telemedicine at >9 weeks of gestation is associated with a higher risk of same-day or day-after clinical visits for concerns related to the procedure, and this risk increases with gestational age. 22.5% of the women with a GA of 11-14 weeks made such a visit, compared to 11.7% for GA 9-11, and just 3.3% for ≤9 weeks. This means that in this study, women with GA of >9 weeks had a four-fold increased risk of clinical visits, compared to those at ≤9 weeks.
Bleeding and Pain – more than expected.
The authors conclude that self-reported rates of heavy bleeding, low satisfaction, or unmet expectations with medical abortion do not increase with gestational age.
However, it is worth noting that a significant proportion of these women did report that the rate of bleeding and of pain were more than expected:
Among women undergoing an abortion at ≤9 or >9 weeks of gestation, the rate of bleeding more than expected was 45.6% versus 57.8% and the rate of pain more than expected was 35.6% versus 38.8%.
The experience of more bleeding or more pain did not impact the safety of the abortion procedure and did not seem to lower the level of women’s satisfaction / acceptability.
Lost to follow-up (LTFU).
During the study period, 1,220 women in Poland contacted WoW requesting a MA. It’s interesting that all of those who made contact were ‘approved’ by WoW for the MA and sent the medication. 13.6% of women received the medication but decided not to use it. WoW was unable to confirm what happened for 427, 35%, of the women who made no further contact after the medication was sent. The authors state that this hight rate of LTFU, 35%, was in line with other studies and so within an expected range.
This drop-out rate of almost 50% is much higher than one might expect, especially with such a large group, and is worth watching for future studies and evaluations of abortion-at-home operations in GB and other countries during this COVID-19 pandemic.
A total of 615 women self-administered the abortion pills at home, of which 427 were ≤9 weeks GA and 188 >9. Follow-up data were collected from 419 of this group, of which 295 were ≤9 weeks GA and 124 >9.
37 women of ≤9 GA had a surgical intervention (vacuum aspiration or D&C after medical abortion) to complete their abortion. Assuming all those not participating in the follow-up were complete after the medication, the rate requiring this intervention is 37/427 = 8.6%. The rate for those who were >9 weeks is 28/188 = 14.9%.
One-in-nine (65/615) women taking the abortion pills at home needed surgical intervention to complete their abortion.
These rates are well above the normally stated expected failure rates for MA using a combination of mifepristone and misoprostol. BPAS shows on its website an expected failure rate requiring surgical treatment of 3% for GA ≤9 weeks and 7% for >9.
The authors note this higher than expected rate and muse if this is related to clinical practice in Poland.
This higher reported failure rate at-home compared to in-clinic, is worth further investigation.
Self-assessment of GA.
Throughout the report, there are numerous mentions of some uncertainty about the actual GA at the time of taking the abortion medication. WoW rely on women accurately self-reporting the first day of their last period, and whilst some studies show that women do so with satisfactory accuracy, there is enough uncertainty to warrant further investigations into this.
Additional doses of misoprostol
It is reported that WoW routinely sends an additional dose, 800 mcg, of misoprostol to women reporting to be >9 weeks GA, though the authors note the uncertainty of predicting the GA at the time of self-administration of the pills. The reason for doing this is the expectation that for some women their abortion will not be complete after the first dose of misoprostol, but one cannot predict to which women this will apply. Providers in GB, and in other countries, are now routinely sending additional doses of misoprostol to all women participating in abortion-at-home during the COVID-19 regulations.