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Submitted on June 30, 2015; resubmitted on August 18, 2015; accepted on August 24, 2015
study question: Can the need of subsequent abortion be reduced by providing intrauterine contraception as a part of the abortion
service?
summary answer: Provision of intrauterine devices (IUDs) in association with first trimester abortion more than halved the incidence of
repeat abortion during the first year of follow-up.
what is known already: Following abortion, the incidence of subsequent abortion is high, up to 30 –40%. In cohort studies, intra-
uterine contraception has reduced the need of repeat abortion by 60– 70%.
study design, size, duration: A randomized controlled trial. The main outcome measure was the incidence of subsequent induced
abortions during the follow-up. Altogether 751 women seeking first trimester induced abortion were recruited and randomized into two groups.
Randomization was accomplished by computer-assisted permuted-block randomization with random block sizes of four to six. The investigators
did not participate in randomization, which was done before commencing the study. The participants were recruited between 18 October 2010
and 21 January 2013.
participants, settings, methods: The inclusion criteria were age ≥18 years, duration of pregnancy ≤12 weeks, accepting intra-
uterine contraception, residence in Helsinki and signing the informed consent form. Women with contraindications to intrauterine contraception,
such as uterine anomaly, acute genital infection or pap-smear change requiring surgical treatment were ineligible to participate.
This study was conducted in collaboration between the Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki Uni-
versity Hospital, and Centralized family planning of the City of Helsinki.
The intervention group (n ¼ 375) was provided with intrauterine contraception (either the levonorgestrel-releasing intrauterine system or
copper-releasing intrauterine device) immediately following surgical abortion (18.1%) or at a follow-up 2– 4 weeks after medical abortion
(81.9%). Women in the control group were prescribed oral contraceptives and advised to contact their primary healthcare unit for a follow-
up visit and further contraceptive services according to national guidelines. The women were followed-up to 28 February 2014 by using the
Finnish National Abortion Registry, Helsinki University Hospital electronic database and clinical follow-up visit at 1 year.
main results and the role of chance: The median age of the whole study group was 27 years and 44% had a history of induced
abortion(s). During the follow-up year the number of women requesting subsequent abortion was significantly lower in the intervention than in the
control group (9/375 [2.4%] versus 20/373 [5.4%], difference 23.0 [95% CI 26.0 to 20.2] percentage points, P ¼ 0.038, according to inten-
tion-to-treat analysis and 5/346 [1.4%] versus 20/357 [5.6%], difference 24.2(27.2 to 21.4) percentage points, P ¼ 0.003, according to
†
Equal first author contribution.
& The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.
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2540 Pohjoranta et al.
per-protocol analysis, respectively). Provision of intrauterine contraception was safe with rate of infection and expulsion similar to those reported
previously.
limitations, reasons for caution: The power calculation was calculated for a 5-year follow-up. However, significant differences
between the two groups were already seen after 1 year. The present study was performed in a single clinic, where, 15% of all abortions in Finland
are performed.
wider implications of the findings: In order to decrease the need of subsequent abortions, IUDs should be provided at the time
of abortion.
study funding/competing interest(s): This study was supported by Helsinki University Central Hospital Research funds and
by research grants provided by the Antti and Jenny Wihuri Foundation and the Yrjö Jahnsson Foundation. O.H. has served on advisory boards for
willingness to participate and to sign the informed consent form. Exclusion additional hospital visits was analysed to assess possible adverse events
criteria were contraindications to intrauterine contraception (i.e. acute related to the IUD insertion.
genital infection, Pap-smear change necessitating surgical intervention or
known uterine structural abnormality). In addition, acute liver disease and
Study overseers
breast cancer were contraindications for the LNG-IUS; and Wilson’s
disease, copper allergy, iron deficiency anaemia and history of ectopic preg- The trial received approval from the Ethics Committees of the City of Helsinki
nancy for Cu-IUD. (10-1138/054) and the Hospital District of Helsinki and Uusimaa (HUS 260/
13/03/03/2009). Approval to carry out the study was granted by the Hos-
pital District of Helsinki and Uusimaa (§12/30.03.2010). The trial was regis-
Randomization tered at the Clinical Trials website (www.clinicaltrials.gov [NCT01223521]).
Randomization was accomplished by computer-assisted permuted-block Approval to use personal-level data was obtained from the National Insti-
randomization with random block sizes of four to six. The investigators did tute for Health and Welfare as required for registry-based studies in Finland
Statistical analysis
Study procedures
Based on earlier studies, we assumed that the risk of subsequent induced
The method of induced abortion was decided individually on the basis of pos- abortion is 15% during the 5-year follow-up time (Heikinheimo et al.,
sible contraindications and the women’s preferences. Medical abortion was 2008) and that provision of intrauterine contraception reduces this risk by
performed by administration of mifepristone followed by misoprostol 2 – 4 50%. Using the log-rank test and with a 1-year accrual time, for a 5-year
days later vaginally either at the hospital (n ¼ 227, 37.5%) or at home total study time with 80% power and a 5% significance level, we needed at
(n ¼ 378, 62.5%). Women choosing surgical abortion received misoprostol least 350 women in each group. Subsequently, a total of 751 women were
prior to vacuum aspiration under general anaesthesia. All procedures were recruited during the study period (18 October 2010– 21 January 2013; Fig. 1).
performed according to national guidelines (The Finnish Medical Society The planned duration of the study is 5 years. However, at the time of the
Duodecim, 2013). 1-year follow-up visit it became apparent that there might be a difference in
The women in the intervention group choosing surgical abortion received the rate of repeat abortion between the study groups, we modified the
the cost-free IUD (Cu-IUD [Nova-Tw] or LNG-IUS [Mirenaw], both from protocol, and applied for an approval to perform the registry-based analysis
Bayer Ag, Turku, Finland) at the time of vacuum aspiration. Its correct place- already at 1 year. Thus, in the present analysis the primary outcome was the
ment was confirmed by vaginal ultrasonography at the follow-up visit at 2 – 4 rate of subsequent induced abortion during the first year following the index
weeks afterwards. For women choosing medical abortion, the IUD was abortion. Secondary outcomes were contraception prior to repeat abortion,
inserted at the follow-up visit in cases with no complications. timing of repeat abortion and adverse events related to IUD insertion.
The women in the control group were mainly prescribed oral contracep- All analyses were performed with PASW statistics software, version 18
tives for 1 year and advised to contact their primary healthcare unit for the (SPSS Inc., IL, USA). Analyses were conducted on an intention-to-treat
follow-up visit, including planning further contraception (including IUD pro- (ITT) and a per-protocol (PP) basis. Statistical significance was defined as
vision), which is the current practice in Finland (The Finnish Medical P , 0.05. Differences in continuous variables were analysed by means of
Society Duodecim, 2013). the Mann– Whitney U-test for skewed data. The data are presented as
medians (with interquartile range [IQR]). x 2 or Fisher’s exact tests were
Follow-up used as appropriate for independent nominal data. Differences of propor-
After 3 months, women in the intervention group had an appointment with tions and their 95% confidence intervals (CIs) were calculated using New-
the study nurse to confirm acceptability of intrauterine contraception and the combe’s method. Kaplan –Meier survival analysis with the log-rank test
proper placement of the IUD by direct visualization of the IUD strings. Ultra- was used to analyse cumulative subsequent induced abortions.
sonography was used if the strings were missing or appeared too long. In
cases of expulsion or dislocation (n ¼ 18), a new device was offered.
All women were provided with a questionnaire regarding physical, mental, Results
sexual and reproductive health, and quality of life at enrolment, at 3 months,
and at 1 year after the abortion. A reminder text message was sent twice if the Study participants
follow-up questionnaire had not been received. Of the total of 2305 eligible women requesting induced abortion during
The next follow-up visit was scheduled 1 year after abortion for all women
the study period, 1139 (49.4%) expressed an interest in intrauterine
participating in the study. In cases of no-show, the women were contacted
contraception (Fig. 1). A majority of them (751, 65.9%) were randomized
twice by phone. If they could not be reached, a letter was sent to schedule
a new appointment. into the study. After randomization, three women decided to continue the
Women in both study groups requesting another abortion up to 28 Feb- pregnancy and were excluded from all analyses. The remaining 748
ruary 2014 were identified in the National Abortion Registry and Helsinki women were included in the ITT-analysis. Twenty-seven women rando-
University Hospital electronic database. All women requesting subsequent mized to the intervention group did not receive an IUD (none in the
abortion either with a viable intrauterine pregnancy, spontaneous miscar- group of surgical abortion and 27 in the group of medical abortion, P ¼
riage or ectopic pregnancy diagnosed at the time of assessment for abortion 0.011) and were excluded from the PP analysis as a result of this protocol
were included in the group. violation. Sixteen women in the control group who received an IUD at
the time of surgical abortion were also excluded from the PP analysis.
Adverse events Table I summarizes the characteristics of the study participants. The
All participants after the index abortion were advised to contact the hospital median (IQR) age of the whole study group was 27 (23 –33) years.
should symptoms of possible complications arise. Information on all Nearly half (48.4%, 362/748) of the women were parous and 43.7%
2542 Pohjoranta et al.
(327/748) had a history of induced abortion(s). Randomization did not Secondary outcomes
result in any statistically significant differences in clinically important back-
The median time (with IQR) to subsequent induced abortion was
ground factors between the groups.
8 (6–11) months. None of the unplanned pregnancies occurred during
In the intervention group, 307 (81.3%) women chose medical abor-
the use of intrauterine contraception. Half of the women (12/24)
tion, and 68 (18.7%) surgical (Fig. 1). For women choosing medical abor-
undergoing subsequent abortion used no contraception at the time of
tion, 302 women received the IUD within 4 weeks after the abortion, and
conception (Table III).
the remaining 46 later. Median (quartiles) time from induced abortion to
Comparison of the data on subsequent induced abortions included in
insertion of IUD was 20 (17 –24) days.
the national registry and in the hospital registry showed a 95.8% match,
with one missing case in the national registry.
Primary outcome Altogether 380 (50.5%) women attended the follow-up visit at 1 year
During the first year of follow-up 29 (3.9%) and 25 (3.5%) women were (225 [59.7%] in the intervention group and 155 [41.2%] in the control
referred to hospital with a request for an induced abortion according to group). The response rate as regards the questionnaires at 1 year was
the ITT and PP analyses, respectively (Table II). Finally, 24 (3.2%) women 60.7% in the intervention group and 42.3% in the control group.
in the ITT-analysis group and 20 (2.8%) women in the PP analysis group Among women requesting a new abortion, the response rate was as
underwent subsequent induced abortion. The remaining five women low as 17.2%. Only 4 of the 24 women undergoing a subsequent abortion
were diagnosed with miscarriage (n ¼ 3) or ectopic pregnancy (n ¼ 2). self-reported it in the questionnaire, resulting in only 16.7% concordance
Thus, study intervention decreased the request for subsequent abor- with the abortion registry (Table III).
tions by more than half. The number of induced abortions was
reduced to one-third (ITT-analysis) or one-fifth (PP analysis).
The cumulative proportion of women without subsequent induced Adverse events
abortion at 1 year was 98.4% in the intervention group and 95.0% in There were no cases of uterine perforation after IUD insertion. Al-
the control group (P ¼ 0.012; Fig. 2). together 18 (5.2%) total or partial expulsions were detected by the
The rate of repeat abortion in the intervention group was 0% (0/68) time of the 3-month follow-up visit. The rate was 7.2% (5/70) after sur-
following surgical and 2.0% (6/307) following medical abortion gical termination and 4.7% (13/307) after medical termination. All of
(P ¼ 0.25). The corresponding figures were 2.7% (2/74) and 5.4% these women were offered a new IUD; four declined and initiated oral
(16/299) in the control group (P ¼ 0.34). contraceptives.
Intrauterine contraception after induced abortion 2543
study, younger women were hesitant when considering an IUD for post-
Table III Characteristics of the women (n 5 24) abortal contraception. Intrauterine contraception has been shown to be
undergoing subsequent abortion during the first year of
effective and highly acceptable among young and nulliparous women
follow-up after the index abortion. ITT-analysis.
(Suhonen et al., 2004; Yen et al., 2010; Secura et al., 2014; Kaislasuo
Variable GROUP P-value et al., 2015). Even though the overall use of intrauterine contraception
........................................ is high (up to 18%) in Finland this form of contraception should be
Intervention Control
(n 5 6) (n 5 18) further encouraged among young women especially after an unwanted
........................................................................................ pregnancy.
Age (years) 33 (31 –37) 23 (21 –26) 0.001 The women were followed-up by using the Finnish National Abortion
[median (range)] Registry as well as the hospital database. In previous studies the reliability
Parousa 5 (83.3) 6 (33.3) 0.033 of the National Abortion Registry has been high, with 99% of all
even larger. It is also noteworthy that in the intervention group all women Bajos N, Lamarche-Vadel A, Gilbert F, Ferrand M; COCON Group, Moreau C,
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Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT.
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Immediate versus delayed IUD insertion after uterine aspiration. N Engl J
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