Acceptability of medical termination of pregnancy
up to 63 days of gestation with home
administration of misoprostol: assessment of
significant factors
Kopp Kallner, H1; Fiala, C2; Gemzell-Danielsson, K1
1 Department of Obstetrics and Gynaecology, Karolinska Institute 7,
Stockholm, Sweden; 2 Gynmed Clinic, Austria
Objective: The objective of this study was to identify significant
factors affecting acceptability of home administration of
misoprostol for medical termination of pregnancy (TOP) up to
63 days of gestation.
Methods: This study was conducted in a University Hospital
Outpatient Family Planning Clinic. Women who were in good
general health, above 18 years of age, with no contraindication to
medical TOP, requesting medical TOP with home administration
of misoprostol and with pregnancies up to 63 days of gestation as
evaluated by ultrasound were asked to participate. Women
received 200 mg of mifepristone in the clinic and were instructed
to self-administer 0.8 mg of misoprostol vaginally at home 36–
48 hours later. Women filled in questionnaires which were
answered after the TOP and at follow up. Patients also filled in
daily symptom diaries. Follow-up was 2 weeks later with physical
examination and low sensitivity urine-hCG according to clinical
practice. All factors extracted from the questionnaires which could
potentially affect acceptability were analysed using multivariate
logistic regression.
Results: In total, 395 women who opted for home administration
of misoprostol for medical TOP were recruited. We found that
the presence of a partner/friend during the TOP affected
acceptability in a positive direction (P = 0.021). In contrast,
having a positive low sensitivity urine hCG at follow up affected
acceptability negatively (P = 0.002), although most of these
women had a successful and complete TOP. In contrast to other
studies on medical TOP, we could not find an influence of age,
gestational length or the requirement of extra pain medication on
overall acceptability of the procedure.
Conclusions: Home administration of misoprostol for medical
TOP up to 63 days of gestation is highly acceptable. Women
should be encouraged to have a partner/friend present during the
TOP if possible as this affected acceptability of the procedure in
this study. In order to further increase acceptability of home
administration of misoprostol, focus of future research should be
directed towards increasing the number of complete TOPs in a
shorter time frame.
The efficacy, safety and acceptability of medical termination of pregnancy provided by standard care by physicians or by nurse-midwives: a randomized controlled equivalence trial
Helena Kopp Kallner, Rebecca Gomperts, Eneli Salomonsson, Monica Johansson, Lena Marions, Kristina Gemzell-Danielsson Karolinska Institutet, Stockholm, Sweden - helena.kopp-kallner@ki.se
Objective: To assess nurse-midwife provision of early medical termination of pregnancy (TOP) in a high resource setting where ultrasound examination for dating of pregnancy is part of the protocol. Method: We performed a randomized controlled equivalence trial in a Univerity Hospital Family planning outpatient unit. 1180 women seeking early medical TOP were randomized, without any prior examination, to counselling, examination and treatment by either nurse-midwife or gynaecologist. Ultrasound was performed in all cases by the allocated provider. Primary outcome was efficacy defined as successful completion of TOP without need for vacuum aspiration. Secondary outcomes were safety, defined as need for hospitalization or blood transfusion, and acceptability, defined as preferred provider were the women to have a medical TOP in the future. Results: A total of 481 women in the nurse-midwife group and 457 women in the physician group were available for final analysis. The effectiveness of provision of medical TOP by nurse-midwife providers was superior to that provided by physicians (risk difference 1.6%, confidence interval 0.2-3.0% which was within the set margin of equivalence). There were no significant differences in safety parameters. Women examined and counselled by a nurse-midwife were significantly more likely (p<0.001) to prefer seeing a nurse-midwife for the consultation were they to have another medical TOP in the future. Conclusions: These findings show that nurse-midwife provision of early medical TOP in a high-resource setting where ultrasound is part of the protocol is effective and can be safely implemented with high acceptability among women.
Helena Kopp-Kallner, Karolinska Institute, Sweden
In 1997 home administration of misoprostol was shown to be a safe option up to 56 days gestation (Schaff et al J Fam Pract, 1997. 44(4): p. 353-60) and studies of efficacy of home administration of vaginal administration of misoprostol at home for medical abortion have recently included women with pregnancies up to 63 days gestation (Westhoff et al Analgesia during at-home use of misoprostol as part of a medical abortion regimen. Contraception, 2000. 62(6): p. 311-4, Creinin et al Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. Obstet Gynecol, 2007. 109(4): p. 885-94, Kopp Kallner et al Home self-administration of vaginal misoprostol for medical abortion at 50-63 days compared with gestation of below 50 days. Hum Repr 2010 May;25(5):1153-7).
In Europe, medical abortion was introduced and used in clinics and most countries have not adapted their legislation or interpretation of legislation to home use of misoprostol for medical abortion. When medical termination of pregnancy was introduced in the U.S. in the year 2000, home administration of misoprostol became the standard treatment.
Home use of misoprostol has so far been studied only after administration of mifepristone. The regimen is identical to that used in medical abortion in clinics and efficacy rates are identical to medical abortion in clinics. The most frequently mentioned reasons for medical abortion are perception of a more natural course and higher safety, avoidance of surgery or general anaesthesia and having more privacy and autonomy. Women often object to the number of visits required for a medical abortion. Women are required to visit the clinic three or four times to have a medical termination performed, depending on mandatory waiting periods and number of follow-up visits (Winikoff, Acceptability of medical abortion in early pregnancy, Fam Plann Perspec 1995, 27(4): p. 142-8, 185).
Home use of misoprostol is therefore an attractive treatment option for many women requesting medical abortion. Acceptability does not depend on gestational age or parity and has been been shown to be high among women and their partners (Kopp Kallner et al Home self-administration of vaginal misoprostol for medical abortion at 50-63 days compared with gestation of below 50 days. Hum Repr 2010 May;25(5):1153-7).
Women should be carefully counselled and given realistic expectations as to pain and bleeding. They should be provided with written and oral instructions for the procedure. Measures should be taken to confirm that the pregnancy has been successfully terminated.
Unplanned pregnancy- a common reason for
ectopic pregnancy
Kopp Kallner, H
Karolinska Instiutet, Department of Obstetrics and Gynecology,
Danderyd Hospital, Stockholm, Sweden
Objectives: The primary objective of this study was to investigate
what proportion of ectopic pregnancies arises as a consequence of
unplanned pregnancies and the proportion of women receiving
contraceptive counselling after treatment.
Background: Ectopic pregnancy is a potential life threatening
condition. It has a negative impact on future fertility which is
often desired. It is often forgotten that an ectopic pregnancy can
be a consequence of an unplanned pregnancy.
Methods: This was a retrospective study of a total of 68 patients’
electronic medical records. Inclusion criteria were a certain
diagnosis of an ectopic pregnancy and first visit at Danderyd
Hospital AB between 1 June 2011 and 30 November 2011.
Results: Fifty-four percent of the ectopic pregnancies were a
consequence of an unplanned pregnancy, 31% were planned and
information was missing for 15% of the patients. In the group of
patients with unplanned pregnancy 70% of the patients in need of
counselling on future contraceptives did not get it upon
completed treatment.
Conclusions: A large proportion of ectopic pregnancies are a
result of unplanned pregnancy. The individual and the healthcare
system have a lot to gain by ectopic pregnancy prevention which
can be achieved by increased use of contraceptives which protect
patients against all unplanned pregnancies. Patients with
unplanned ectopic pregnancies should receive counselling on
future contraceptives after finished treatment.
Use of contraception and attitudes towards contraceptive use in Swedish women: a nationwide survey
Helena Kopp Kallner1, Louise Thunell4, Jan Brynhildsen3, Mia Lindeberg2, Kristina Gemzell-Danielsson1 1Karolinska Institutet, Stockholm, Sweden, 2MSD, Stockholm, Sweden, 3Linköping University, Linköping, Sweden, 4Lund University, Lund, Sweden - helena.kopp-kallner@ki.se
Objective: To describe contraceptive use and attitudes towards contraceptive use in Sweden. Secondary objectives were to investigate knowledge of contraceptive methods and how women handle unplanned and unwanted pregnancies. Method: We performed a national telephone survey of women aged 16-49 years. The survey contained 22 questions with answers being of both spontaneous and multi-choice character on demographics, contraceptive use, knowledge of and attitudes towards contraception, the importance of monthly bleeding and experience of unintended pregnancy. Main outcome measures were distribution of use of contraceptive methods and non-use of contraception among Swedish women and prevalence and outcome of unintended pregnancies. Results: A total of 1001 women participated in the survey. Of all women, 721/1001 (72.1%) women currently used contraception, 268/1001 (26.8%) women did not use contraception and 12/1001 (1.2%) had stopped using contraception sometime in the last 12 months. A total of 781 (78%) women had never experienced an unintended pregnancy whereas 220 (22%) women had had at least one unintended pregnancy. Users and non-users alike stated that one of the most important characteristics of a contraceptive method is its effectiveness. Conclusions: A large proportion of Swedish women do not use contraception. Furthermore, a large proportion of women have experienced at least one unintended pregnancy. Increasing awareness of contraceptive effectiveness and promoting use of all contraceptive methods and especially long-acting reversible contraception is a possible way forward in the effort to reduce the rates of unintended pregnancy, unwanted pregnancy and termination of pregnancy.
How will we be able to secure the right for abortion? Around the world, in a lot of countries where abortion is legal, women have great difficulties to have access to abortion. A few countries have regulations that state CO is not permitted for health care providers working in the field of reproductive health (Sweden, Finland, Iceland).
Is this an actual solution for other countries? In most countries, individual CO is written in the abortion law and in medical law, and in Belgium, abortion providers agree to this.
Which woman wants to be treated by a team that has a negative feelings towards abortion? Anti-choice health care workers obliged to work in the field of abortion could make it a traumatic experience!
In countries where CO is permitted, our actual fight should focus on the following:
The state should ensure that abortion services are available in each region (in hospitals or in outpatient facilities) and make sure women know where to go. Public hospitals should offer an abortion service if they want to keep their state funding. Public hospitals should not have the “right” of conscience. Objector status of doctors should be public and quick referral to an abortion service mandatory. Providers, who work in abortion services, should choose to do so (conscientious commitment) so that women are treated with respect and empathy.
Doctors performing abortions should not be discriminated and should be dismissed from other tasks who need to be taken over by conscientious objectors. Women’s rights movements should encourage feminists to become doctors and young doctors to perform abortion and be proud to do so. We need to do a charm offensive to show that working in abortion care permits rich human encounters with women grateful to be able to decide about their future life.
PS03.2
Expanding providers and task sharing
Helena Kopp Kallner
Karolinska Institutet, Stockholm, Sweden
In many countries the access to medical doctors in abortion care is limited either by a general shortage of medical doctors or by the unwillingness of medical doctors to be involved in abortion care. Specially trained, midlevel providers can often perform services generally performed by physicians. In abortion care the evidence in support of midlevel provision of surgical and medical abortion and postabortion care is increasing.
In some countries midlevel providers perform primary vacuum aspiration for surgical abortion and in low resource settings midlevel providers supply medication and information and thereby perform medical abortions. Medical abortion provided by midlevel providers in a low resource setting has been evaluated in a large randomised trial in Nepal and was found to be safe and effective.
In high resource settings abortion is usually provided after an ultrasound provided by a trained physician. However, access to appointments for ultrasound may, in fact, increase the waiting time to have an abortion. In a large randomised trial it has been shown that trained midlevel providers can perform early medical abortion including the ultrasound as part of standard care as effectively and safely as physicians.
Women in countries where abortion is illegal often self induce abortions surgically or medically. Denied health care due to complications contributes to maternal morbidity and mortality. Midlevel providers who supply postabortion care including manual vacuum aspiration for incomplete abortion have been shown to be safe and effective. In a large randomised trial it has been shown that trained, midlevel providers can perform postabortion care as effectively and safely as physicians in rural as well as in urban settings in Africa.
CS04.3
Quickstarting implants after medical abortion
Helena Kopp Kallner
Karolinska Institutet, Stockholm, Sweden
Given the choice, the majority of women in the first trimester choose medical rather than surgical abortion. In Europe, and globally, a significant proportion of women having an abortion have had one or more previous abortions. Long acting reversible contraception reduces subsequent abortions in women. In studies, women resumed sexual intercourse quickly and are thus at risk for unintended pregnancy if effective contraception is not provided. Immediate postabortion initiation of long acting reversible contraception is therefore desirable and recommended by guidelines.
Implants are the only long acting contraception which can be provided at the same time as the initial abortion medication. However, theoretically treatment with a progestin could affect the binding of mifepristone to the progesterone receptor.
Several pilot studies have reported implant insertion at the time of mifepristone in medical abortion. In addition, there is one randomised study performed in Mexico and the United States and one randomised study performed in Sweden and Scotland. Women were randomised to implant insertion at the time of mifepristone ingestion or at follow up. These studies show that implant insertion at the time of the mifepristone is safe and acceptable for women. In addition, the efficacy of the medical abortion is not affected. In the study from Mexico and the United States insertion rates differed between countries and no difference could be shown in unintended pregnancy at the 6 month follow up. The study from Sweden and Scotland had similar insertion rates to women recruited in the United States. There was a significant difference in unintended pregnancy at the 6 month follow up between the immediate and delayed insertion group.
Thus, immediate insertion of implants is safe and acceptable and may prevent subsequent abortions as early as 6 months postabortion.