Factors affecting female sexual well-being: a 5-year follow-up of a randomised clinical trial on post-abortion contraception.

INTRODUCTION: Sexual well-being is associated with general well-being. Several factors, such as overweight, infertility, anxiety and sex hormones, also play a role, but the effects of hormonal contraception remain a point of debate. We characterised the factors associated with sexual well-being in fertile-aged women following induced abortion. METHODS: A 5-year follow-up of a nested, longitudinal, cohort study examining the effects of routine provision of intrauterine contraception as part of abortion care. Sexual well-being, anxiety and quality of life were assessed annually using validated questionnaires (McCoy Female Sexuality Questionnaire, State-Trait Anxiety Inventory and EuroQoL), along with data on general and reproductive health, and relationship status. Of the 742 women participating in the trial, 290 (39%) provided sufficient follow-up data and were included in this study. RESULTS: Based on trajectories of McCoy scores across the 5-year follow-up, two groups were identified: those with stable and higher (n=223, 76.9%) and those with declining sexual well-being (n=67, 23.1%). Women in the group of declining sexual well-being had significantly higher levels of anxiety and lower quality of life at all time points. They also had chronic diseases more often and were less happy in their relationships. No differences were found in method of contraception when classified as hormonal versus non-hormonal, or long-acting versus short-acting reversible contraception. CONCLUSIONS: Lower anxiety and higher quality of life are associated with stable and higher sexual well-being. Method of contraception or relationship status are not associated with sexual well-being during long-term follow-up in fertile-aged women.

Pregnancy outcomes following routine early provision of intrauterine device after first-trimester induced abortion-A secondary analysis of a randomized controlled trial with a 5-year follow up.

INTRODUCTION: Women undergoing an induced abortion are highly fertile and at risk of subsequent unplanned pregnancy. We recently completed a randomized clinical trial showing that routine provision of intrauterine device (IUD) at the time of abortion significantly reduced the risk of subsequent abortion during a 5-year follow up. As the use of highly effective contraception may affect all subsequent pregnancies, we analyzed the rate and distribution of all subsequent pregnancies (deliveries, miscarriages, and abortions), and the risk factors for these various pregnancy outcomes in the above-mentioned randomized clinical trial. MATERIAL AND METHODS: We enrolled adult women requesting first-trimester induced abortion and candidates for IUD for post-abortion contraception. Women (n = 751) were randomized to receive an IUD (either levonorgestrel-releasing IUD or copper IUD) by the clinic responsible for abortion care vs. routine care of IUD provision in primary health care with oral contraceptives for interval contraception. In the present secondary analysis, we identified all deliveries, miscarriages, and abortions in the intervention (n = 375) and control (n = 373) cohorts during the 5-year follow up using the Finnish national registries. The trial is registered at Clinical Trials (NTC01223521). RESULTS: The overall delivery, miscarriage, and abortion rates were 42.0, 12.0 and 32.1/1000 years of follow up (yFU). Any new pregnancy occurred in 98 women in the intervention and in 129 women in the control cohort (hazard ratio 0.73, 95% confidence interval 0.56-0.95, p = 0.023). The effect of routine IUD provision in reducing pregnancies was limited to the first 2 yFU. The number of subsequent induced abortions and of women undergoing it were significantly reduced, and time to abortion was prolonged by the intervention. However, the overall number, the number of women with subsequent delivery or miscarriage, and the times to these events were not significantly affected. History of previous pregnancy (delivery or abortion) and smoking were risk factors for subsequent induced abortion, but not for delivery or miscarriage. CONCLUSIONS: Routine provision of IUD as part of abortion care did not reduce the rates of delivery or miscarriage during the 5-year follow up. The rates of all pregnancies and the need of subsequent induced abortion were reduced by IUD provision during the first 2 yFU.

Early provision of intrauterine contraception as part of abortion care-5-year results of a randomised controlled trial.

STUDY QUESTION: Can the incidence of subsequent termination of pregnancy (TOP) be reduced by providing intrauterine contraception as part of the abortion service? SUMMARY ANSWER: Provision of an intrauterine device (IUD) as part of TOP services reduced the need for subsequent TOP but the effect was limited to the first 3 years of the 5-year follow-up. WHAT IS KNOWN ALREADY: An IUD is highly effective in preventing subsequent TOP. Prompt initiation of IUD use leads to a higher usage rate during follow-up, as compliance with post-TOP IUD insertion visits is low. STUDY DESIGN, SIZE, DURATION: The objective of this randomised controlled trial was to assess the effect of early comprehensive provision of intrauterine contraception after TOP, with primary outcome being the incidence of subsequent TOP during the 5 years of follow-up after the index abortion. This study was conducted at a tertiary care centre between 18 October 2010 and 21 January 2013. Altogether, 748 women undergoing a first trimester TOP were recruited and randomised into two groups. The intervention group (n = 375) was provided with an IUD during surgical TOP or 1-4 weeks following medical TOP at the hospital providing the abortion care. Women in the control group (n = 373) were advised to contact primary health care for follow-up and IUD insertion. Subsequent TOPs during the 5-year follow-up were identified from the Finnish Register on induced abortions. PARTICIPANTS/MATERIALS, SETTING, METHODS: The inclusion criteria were age ≥18 years, duration of gestation ≤12 weeks, residence in Helsinki and accepting intrauterine contraception. Women with contraindications to IUD were excluded. MAIN RESULTS AND THE ROLE OF CHANCE: The overall numbers of subsequent TOPs were 50 in the intervention and 72 in the control group (26.7 versus 38.6/1000 years of follow-up, P = 0.027), and those of requested TOPs, including TOPs and early pregnancy failures, were 58 and 76, respectively (30.9 versus 40.8/1000, P = 0.080). Altogether 40 (10.7%) women in the intervention and 63 (16.9%) in the control group underwent one or several subsequent TOPs (hazard ratio 1.67 [95% CI 1.13 to 2.49], P = 0.011). The number of TOPs was reduced by the intervention during years 0-3 (22.2 versus 46.5/1000, P = 0.035), but not during years 4-5 (33.3 versus 26.8/1000, P = 0.631). LIMITATIONS, REASONS FOR CAUTION: Both medical and surgical TOP were used. This may be seen as a limitation, but it also reflects the contemporary practice of abortion care. The immediate post-TOP care was provided by two different organizations, allowing us to compare two different ways of contraceptive service provision following TOP. WIDER IMPLICATIONS OF THE FINDINGS: Providing TOP and IUD insertion comprehensively in the same heath care unit leads to significantly higher rates of attendance, IUD use and a significantly lower risk of subsequent TOP. STUDY FUNDING/COMPETING INTEREST(S): This study was supported by Helsinki University Central Hospital Research funds and by research grants provided by the Jenny and Antti Wihuri Foundation, the Yrjö Jahnsson Foundation and Finska Läkaresällskapet. E.P. has received a personal research grant from the Finnish Medical Society. The City of Helsinki supported the study by providing the IUDs. The funding organisations had no role in planning or execution of the study, or in analysing the study results. TRIAL REGISTRATION NUMBER: The trial was registered at clinicaltrials.gov (NCT01223521). TRIAL REGISTRATION DATE: 18 October 2010. DATE OF FIRST PATIENT'S ENROLMENT: 18 October 2010.

Predicting poor compliance with follow-up and intrauterine contraception services after medical termination of pregnancy.

BACKGROUND: Attendance at post-abortion follow-up visits is poor, but little is known about factors affecting it. OBJECTIVE: To assess the factors associated with non-compliance with post-abortion services and to evaluate differences in rates of attendance and intrauterine device (IUD) insertion according to the type of service provision. METHODS: 605 women undergoing a first trimester medical termination of pregnancy (MTOP) and planning to use intrauterine contraception were randomised into two groups. Women in the intervention group (n=306) were booked to have IUD insertion 1-4 weeks after the MTOP at the hospital providing the abortion, while women in the control group (n=299) were advised to contact their primary healthcare (PHC) centre for follow-up and IUD insertion. RESULTS: In the intervention group, 21 (6.9%) women failed to attend the follow-up visit, whereas in the control group 67 (22.4%) women did not contact the PHC to schedule a follow-up (p<0.001). In both groups, non-attendance was associated with history of previous pregnancy and abortion. Not having an IUD inserted within 3 months was significantly more common in the control group (73.6% (n=220)) than in the intervention group (9.2% (n=28), p<0.001). In the intervention group, predictive factors for not having an IUD inserted were anxiety, history of pregnancy and abortion. However, we identified no significant predictive factors in the control group. CONCLUSIONS: Factors predicting low compliance with post-MTOP follow-up are few. Comprehensive provision of abortion care and post-abortion services seems beneficial for minimising the loss to follow-up and delay in initiation of effective contraception. TRIAL REGISTRATION NUMBER: NCT01223521;Results.

Sexual well-being after first trimester termination of pregnancy: Secondary analysis of a randomized contraceptive trial.

INTRODUCTION: Although termination of pregnancy is one of the most common procedures conducted worldwide, little is known about sexual well-being after termination of pregnancy. The objective of this study was to assess sexual well-being after termination of pregnancy, and factors affecting it during a 1-year follow up. MATERIAL AND METHODS: In total, 748 women requesting first trimester termination of pregnancy and participating in a randomized controlled trial on early provision of intrauterine contraception were provided with questionnaires regarding their sexual life, anxiety, quality of life and contraceptive method used at the time of termination of pregnancy, 3 and 12 months after termination of pregnancy. Sexual well-being was measured by the 9-item McCoy Female Sexuality Questionnaire. Anxiety and quality of life were assessed by the State-Trait Anxiety Inventory (STAI) Scale and EuroQoL questionnaire (EQoL). RESULTS: The McCoy index remained unchanged during the follow up. At all three time-points measured, higher (ie, better) McCoy scores were associated with a lower STAI index (mean difference -2.26 [95% CI -3.23 to -1.29], P < 0.001; -3.76 [95% CI -4.79 to -2.74], P < 0.001; -4.50 [95% CI -5.88 to -3.12], P < 0.001) and being in a relationship (1.16 [95% CI 0.08-2.25], P = 0.023; 1.67 [95% CI 0.43-2.89], P < 0.001; 2.81 [95% CI 1.28-4.34], P < 0.001), and correlated positively with a higher EQoL index (r = 0.20, r = 0.20, r = .27, P < 0.001) and higher frequency of intercourse (r = 0.50, r = 0.46, r = 0.42, P < 0.001). Women using intrauterine contraception had higher McCoy index measurements at 3 months compared with others. There were no significant differences between users of hormonal vs non-hormonal contraceptive methods. CONCLUSIONS: Sexual well-being does not change significantly after termination of pregnancy. Instead, it is strongly and positively associated with quality of life, relationship status and frequency of intercourse. Anxiety is negatively associated with sexual well-being.

Intrauterine contraception after medical abortion: factors affecting success of early insertion.

OBJECTIVE: To assess the success and factors affecting early intrauterine device (IUD) provision after first trimester medical termination of pregnancy (MTOP). STUDY DESIGN: Subgroup analysis of a randomized contraceptive trial assessing the long-term effects of early provision of intrauterine contraception following abortion. Altogether, 606 women undergoing MTOP were included and followed for 3 months. The intervention group (n=307) was offered an IUD (either the levonorgestrel-releasing intrauterine system or copper-IUD) at a follow-up visit 1-4 weeks after MTOP. The control group (n=299) contacted primary health care for follow-up and contraceptive provision. Adverse events (infections, bleeding, residual tissue and incomplete abortion) were analyzed on intention-to-treat basis and IUD expulsions on per-protocol (PP) basis. RESULTS: In the intervention group, 234 women (76.2%) received the IUD as scheduled, 46 later (altogether 91.2%). In the control group, the corresponding figures were 8 (2.7%) and 64 [altogether 24.1%, Odds ratio (OR) (95% Confidence interval (CI))=32.7 (20.3-52.6)]. Eighty-five (27.7%) women in the intervention group and 38 (12.7%) in the control group received treatment (administration of antibiotics, misoprostol or surgical evacuation) because of presumed adverse event [2.63 (1.72-4.01)], mainly residual tissue. In the control group, 23 (60.5%) of these occurred during the first 2 weeks. IUD expulsion occurred in 12 (5.4%) of the 222 women in the intervention group (PP basis). CONCLUSIONS: When provided as part of abortion service, most early insertions following MTOP were performed as planned. The main reason for postponement was overdiagnosis of adverse events suspected at follow-up. The rate of IUD expulsion was similar to that reported previously. IMPLICATIONS: Early insertion following MTOP is safe, and the rate of IUD expulsion is low. Most adverse events possibly delaying IUD insertion occur early. Based on timing of adverse events in the control group, IUD insertion at approximately 2 weeks after completed MTOP seems optimal.

Anxiety and quality of life after first-trimester termination of pregnancy: a prospective study.

INTRODUCTION: Possible effects of termination of pregnancy (TOP) on mental health are a matter of debate. MATERIAL AND METHODS: We assessed anxiety and quality of life during a one-year follow up after first-trimester TOP using the State-Trait Anxiety Inventory (STAI) Scale and EuroQoL Quality of Life Questionnaire (EQ-5D, EQ-VAS) in 742 women participating in a randomized controlled trial on early provision of intrauterine contraception. The measurements were performed before TOP, at 3 months and 1 year after TOP. Inclusion criteria were age ≥18 years, residence in Helsinki, duration of gestation <12 weeks, non-medical indication for TOP, and approval of intrauterine contraception. The trial was registered with Clinical Trials [NCT01223521]. RESULTS: When compared with baseline, the overall anxiety level was significantly lower and quality of life higher at 3 months and at 1 year. Reduction of anxiety and improvement of quality of life was especially evident (p < 0.001) in the 58% of women reporting clinically relevant anxiety at baseline. High levels of anxiety at baseline, history of psychiatric morbidity and smoking predicted significantly greater risk of poorer quality of life and elevated level of anxiety during the follow up. CONCLUSIONS: TOP is associated with a significant overall reduction of anxiety and an improvement of quality of life among women undergoing it for non-medical indications. High baseline anxiety, history of psychiatric morbidity and smoking are risk factors of persistently high levels of anxiety and poor quality of life after an induced abortion. These data are important when designing and providing post-abortion care.

Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial.

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, intrauterine 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 intrauterine 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 University Hospital, and Centralized family planning of the City of Helsinki.The intervention group (n = 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 -3.0 [95% CI -6.0 to -0.2] percentage points, P = 0.038, according to intention-to-treat analysis and 5/346 [1.4%] versus 20/357 [5.6%], difference -4.2(-7.2 to -1.4) percentage points, P = 0.003, according to 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. TRIAL REGISTRATION: The study was registered at www.clinicaltrials.gov (NCT01223521). TRIAL REGISTRATION DATE: 18 October 2010. DATE OF FIRST PATIENT'S ENROLMENT: 18 October 2010.

Attendance at post-abortal follow-up visits is low - can the risks of non-attendance be identified?

Post-abortal follow-up visits are recommended following induced abortion. To assess the rates of attendance and the factors affecting it, we performed a retrospective study of 500 women who had an induced abortion up to 20 weeks of gestation. Altogether, 285 (57%) women attended for the follow-up visit as scheduled. In univariable analysis a history of drug abuse (OR=0.22, 95%CI 0.06-0.81, p=0.02) was associated with non-attendance. Women who underwent medical abortion either at the hospital (OR=3.93, 95%CI 2.61-5.92, p<0.01) or partly at home (OR=3.30, 95%CI 1.86-5.84, p<0.01) and those with a history of human papilloma virus manifestation (OR=2.38, 95%CI 1.04-5.26, p=0.04) were more likely to attend the follow-up visit. The effects of medical abortion and a history of human papilloma virus manifestation persisted in multivariable analysis. We conclude that attendance at post-abortal follow-up visits is low, with only a few clinically significant risk factors predicting non-attendance.