| 1. |
- Bizjak, Isabella, et al.
(författare)
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Contraceptive uptake and compliance after structured contraceptive counseling - secondary outcomes of the LOWE trial
- 2024
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - 0001-6349 .- 1600-0412. ; 103:5, s. 873-883
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Highly effective long-acting reversible contraceptive (LARC) methods reduce unintended pregnancy rates; however, these methods are underutilized. The LOWE trial intervention provided structured contraceptive counseling resulting in increased uptake of LARC. This longitudinal follow up of the LOWE study assessed the long-term impact of the intervention by investigating the contraceptive use at 12 months with a focus on continued use of LARC.MATERIAL AND METHODS: In the cluster randomized LOWE trial, abortion, youth, and maternal health clinics were randomized to provide either structured contraceptive counseling (intervention) or standard contraceptive counseling (control). The intervention consisted of an educational video on contraceptive methods, key questions asked by the health care provider, a tiered effectiveness chart and a box of contraceptive models. Women ≥ age 18, who were sexually active or planned to be in the upcoming 6 months, could participate in the study. We assessed self-reported contraceptive use at three, six and 12 months. Contraceptive choice and switches were analyzed with descriptive statistics. Contraceptive use at 12 months and continued use of LARC were analyzed using mixed logistic regressions, with clinic included as a random effect. Analysis with imputed values were performed for missing data to test the robustness of results.RESULTS: Overall, at 12 months, women in the intervention group were more likely to be using a LARC method (aOR 1.90, 95% CI: 1.31-2.76) and less likely to be using a short-acting reversible contraceptive (SARC) method (aOR 0.66, 95% CI: 0.46-0.93) compared to the control group. Women counseled at abortion (aOR 2.97, 95% CI: 1.36-6.75) and youth clinics (aOR 1.81, 95% CI: 1.08-3.03) were more likely to be using a LARC method, while no significant difference was seen in maternal health clinics (aOR 1.84, 95% CI: 0.96-3.66). Among women initiating LARC, continuation rates at 12 months did not differ between study groups (63.9% vs. 63.7%). The most common reasons for contraceptive discontinuation were wish for pregnancy, followed by irregular bleeding, and mood changes.CONCLUSIONS: The LOWE trial intervention resulted in increased LARC use also at 12 months. Strategies on how to sustain LARC use needs to be further investigated.
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| 2. |
- Elgemark, Karin, et al.
(författare)
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The 13.5-mg, 19.5-mg, and 52-mg Levonorgestrel-Releasing Intrauterine Systems and Risk of Ectopic Pregnancy
- 2022
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Ingår i: Obstetrics and Gynecology. - : NLM (Medline). - 0029-7844 .- 1873-233X. ; 140:2, s. 227-233
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To assess the Pearl Index for risk of ectopic pregnancy in women using levonorgestrel-releasing intrauterine systems (LNG-IUS) with hormonal reservoirs of 13.5 mg, 19.5 mg, or 52 mg. METHODS: This was a retrospective cohort study. Women diagnosed with an ectopic pregnancy in Stockholm County, Sweden, between January 1, 2014, and December 31, 2019, were identified through the electronic medical record system. The final analysis included 2,252 cases of ectopic pregnancy. Information on age, reproductive and medical history, as well as current use of contraception was retrieved. The time of intrauterine device (IUD) insertion before ectopic pregnancy and the numbers of sold LNG-IUS during the study period were used to calculate the incidence rate for ectopic pregnancy during use per 100 woman-years (Pearl Index). RESULTS: Among women with an ectopic pregnancy diagnosis, 105 presented with a known type of hormonal IUD in situ, of whom 94 were included in the calculations of the Pearl Index. The estimated Pearl Index for ectopic pregnancy was 0.136 (95% CI 0.106-0.176) for the LNG-IUS 13.5-mg, 0.037 (95% CI 0.021-0.067) for the LNG-IUS 19.5-mg, and 0.009 (95% CI 0.006-0.014) for the LNG-IUS 52-mg. With the 52-mg LNG-IUS as referent, the relative risk (RR) for ectopic pregnancy was higher during the first year for LNG 13.5-mg (RR 20.59, 95% CI 12.04-35.21), and for both 13.5-mg (RR 14.49, 95% CI 9.01-23.3) and 19.5-mg (RR 4.44, 95% CI 1.64-12.00) during the total study period. CONCLUSION: The absolute risk of ectopic pregnancy during the use of LNG-IUS at any doses was low. The results show that the lower the dose of the IUD, the higher the risk of an ectopic pregnancy. Higher-dose LNG-IUS should be considered when providing contraceptive counseling to a woman with known risk factors for ectopic pregnancy who are considering a hormonal IUD. Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
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| 3. |
- Emtell Iwarsson, Karin, et al.
(författare)
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Increasing uptake of long-acting reversible contraception with structured contraceptive counselling : cluster randomised controlled trial (the LOWE trial).
- 2021
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Ingår i: British Journal of Obstetrics and Gynecology. - : Wiley. - 1470-0328 .- 1471-0528. ; 128:9, s. 1546-1554
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To evaluate the effect of structured contraceptive counselling on uptake of long-acting reversible contraceptives (LARCs), and pregnancy rates.DESIGN: Cluster randomised trial SETTING: Abortion, youth, and maternal health clinics in Stockholm, Sweden.POPULATION: Sexually active women ≥18 years without a wish for pregnancy seeking abortion and/or contraceptive counselling.METHODS: For participants in clinics randomised to intervention, trained health care providers implemented a study-specific intervention package designed for structured contraceptive counselling. Participants in the control clinics received routine counselling.MAIN OUTCOME MEASURES: Primary outcome was choice of LARCs at first visit. Secondary outcomes were LARC initiation at three months and pregnancy rates at three and 12 months. We used logistic mixed-effects models with random intercept for clinic to account for clustering.RESULTS: From September 2017 to May 2019, 28 randomised clinics enrolled 1364 participants. Analyses including 1338 subjects showed that more participants in the intervention compared to control group chose LARCs (267/658 (40.6%) versus 206/680 (30.3%), odds ratio (OR) 2.77, 95% CI 1.99 to 3.86). LARC initiation was higher in the intervention compared to the control group (213/528 (40.3%) versus 153/531 (28.8%), OR 1.74, 95% CI 1.22 to 2.49). At abortion clinics, pregnancy rate was significantly lower at 12 months in the intervention versus the control group (13/101 (12.9%) versus 28/103 (27.2%), OR 0.39, 95% CI 0.18 to 0.88).CONCLUSIONS: Structured contraceptive counselling increased LARC uptake in all clinics and significantly reduced unintended pregnancy rates in abortion clinics at 12 months follow-up.
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| 4. |
- Emtell Iwarsson, Karin, et al.
(författare)
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Long-acting reversible contraception and satisfaction with structured contraceptive counselling among non-migrant, foreign-born migrant and second-generation migrant women : evidence from a cluster randomised controlled trial (the LOWE trial) in Sweden.
- 2022
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Ingår i: BMJ Sexual & Reproductive Health. - : BMJ. - 2515-1991 .- 2515-2009. ; 48:2, s. 128-136
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: This trial aimed to evaluate effects of structured contraceptive counselling among non-migrants, foreign-born migrants and second-generation migrants.METHODS: A cluster randomised controlled trial was conducted in 2017-2019 at abortion, youth and maternal health clinics in Stockholm, Sweden (the LOWE trial). Patients were eligible if they were 18 years or older, could understand Swedish or English (or if assisted by an interpreter), were sexually active or planning to be, and were seeking contraception for pregnancy prevention. We randomised clinics at a 1:1 allocation ratio to give either structured contraceptive counselling (intervention) or to maintain standard contraceptive counselling (control). Blinding was not deemed feasibile. A study-specific package for structured contraceptive counselling was used and comprised an educational video, an effectiveness chart, four key questions and a box with contraceptive models. Outcomes were effects of the intervention on long-acting reversible contraception (LARC) choice, initiation and use, and satisfaction with the intervention material among the participants.RESULTS: We involved 14 clinics in each of the intervention and control groups, respectively. A total of 1295 participants were included: 1010 non-migrants, 169 foreign-born migrants and 116 second-generation migrants. Participants in the intervention group chose LARC to a higher extent than the control group (adjusted OR (aOR) 2.85, 95% CI 2.04-3.99), had higher LARC initiation rates (aOR 2.90, 95% CI 1.97 to 4.27) and higher LARC use within the 12-month follow-up period (aOR 2.09, 95% CI 1.47 to 2.96). The majority of the participants who received the intervention package found all the different parts to be supportive in contraceptive choice. The effectiveness chart was the only part of the package that a higher proportion of foreign-born migrants (58/84, 69%) and second-generation migrants (40/54, 74.1%) found supportive in contraceptive choice compared to non-migrants (259/434, 59.7%) (p = 0.048).CONCLUSIONS: Structured contraceptive counselling increased LARC choice, initiation and use, controlled for participants' migration background. The effectiveness chart was found to be significantly more supportive among foreign-born migrants and second-generation migrants compared to non-migrants when choosing contraceptive methods.TRIAL REGISTRATION NUMBER: NCT03269357.
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| 5. |
- Envall, Niklas, 1984-, et al.
(författare)
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Evaluation of satisfaction with a model of structured contraceptive counseling : Results from the LOWE trial
- 2021
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 100:11, s. 2044-2052
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Intervention trials of structured contraceptive counseling have proved to increase use of long-acting reversible contraceptives (LARCs) and decrease numbers of unintended pregnancies. However, these interventions have not been evaluated from a user perspective. This study aimed to evaluate both healthcare providers’ and participants’ satisfaction with an intervention used in a large trial in Sweden. Material and methods: A cross-sectional study on the intervention group from a cluster randomized trial conducted at 28 clinics in Stockholm, Sweden. Clinics were randomized (1:1 allocation ratio) to provide either structured contraceptive counseling (intervention) or standard contraceptive counseling (control). The intervention consisted of four parts; an educational video to be seen by the participant prior to contraceptive counseling, key questions to be asked by the healthcare provider, an effectiveness chart, and a box of contraceptive models. Eligible participants were 18 years or older, sexually active without a wish to conceive, and with the main purpose of contraceptive use being pregnancy prevention. Healthcare providers completed an electronic semi-structured survey to evaluate the intervention. This study analyses provider and participant satisfaction with the counseling material used in the intervention and if the intervention was found to be supportive in contraceptive counseling and contraceptive choice. Trial registration: ClinicalTrials.gov (NCT03269357). Results: Fourteen intervention clinics enrolled 658 participants from September 2017 to May 2019. Response rate among providers was 88.0% (55/62) and among participants 97.1% (639/658). Providers found the intervention to be supportive in their counseling. Each separate part of the intervention package received high ratings from both providers and participants. Participants found the educational video and the effectiveness chart to be more helpful than the box of contraceptive models in their contraceptive choice. Providers reported the time taken to complete the intervention outside the study to be time-neutral to standard counseling, and most providers wished to continue to use all parts of the intervention package. Conclusions: The intervention of structured contraceptive counseling had high provider and participant satisfaction. The structured counseling package could be used in several clinical settings to improve quality in contraceptive counseling and to enhance informed decision making about use of contraceptive methods. © 2021 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG)
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| 6. |
- Envall, Niklas, 1984-, et al.
(författare)
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Intrauterine mepivacaine instillation for pain relief during intrauterine device insertion in nulliparous women: a double-blind, randomized, controlled trial
- 2019
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Ingår i: Contraception. - : Elsevier BV. - 0010-7824 .- 1879-0518. ; 99:6, s. 335-39
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To evaluate whether intrauterine mepivacaine instillation before intrauterine device (IUD) insertion decreases pain compared to placebo.STUDY DESIGN: We performed a double-blind, randomized, controlled trial comparing mepivacaine 1% 10 mL versus 0.9% NaCl intrauterine instillation using a hydrosonography catheter 5 min before IUD insertion in women 18 years of age or older. Participants completed a series of 10-cm visual analogue scales (VAS) to report pain during the procedure. The primary outcome was the difference in VAS scores with IUD insertion between intervention group and placebo. Secondary outcomes included VAS before and after insertion and analgesia method acceptability.RESULTS: We randomized 86 women in a 1:1 ratio; both groups had similar baseline characteristics. In the intention-to-treat analysis, the primary outcome, median VAS with IUD insertion, was 4.8 cm in the intervention group [n=41, interquartile range (IQR) =3.1-5.8] and 5.9 cm in the placebo group (n=40, IQR=3.3-7.5, p=.062). In the per-protocol analysis, the median VAS with IUD insertion was 4.8 cm (IQR=3.1-5.5) and 6.0 cm (IQR=3.4-7.6) for the intervention and placebo groups, respectively (p=.033). More women in the intervention group reported the procedure as easier than expected (n=26, 63.4% vs. n=15, 37.5%), and fewer reported it as worse than expected (n=3, 7.3% vs. n=14, 35%, p=.006).CONCLUSION: Intrauterine mepivacaine instillation before IUD insertion modestly reduces pain, but the effect size may be clinically significant.IMPLICATIONS STATEMENT: While the reduction in VAS pain scores did not meet our a priori difference of 1.3 points for clinical significance, participants' favorable subjective reaction suggests that this approach merits further study.Copyright © 2019 Elsevier Inc. All rights reserved.KEYWORDS: Contraception; Intrauterine devices; Mepivacaine; Pain; VAS
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| 7. |
- Envall, Niklas, 1984-, et al.
(författare)
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Mepivacaine instillation for pain reduction during intrauterine device placement in nulliparous women : a double-blinded randomized trial
- 2024
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Ingår i: American Journal of Obstetrics and Gynecology. - 0002-9378 .- 1097-6868.
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Fear of pain associated with intrauterine device placement has been identified as a significant barrier to the adoption of long-acting reversible contraception, contributing to lower utilization of the most effective reversible contraceptive methods.OBJECTIVE: To assess whether instillation of intrauterine mepivacaine before intrauterine device placement alleviates pain more effectively than a placebo.STUDY DESIGN: We conducted a multi-center, double-blind, randomized, placebo-controlled trial involving nulliparous women undergoing intrauterine device placement. An instillation of 10 mL of 20 mg/mL mepivacaine or 0.9 mg/mL sodium chloride was administrated through a hydrosonography catheter 2 minutes prior to intrauterine device placement. Pain scores were assessed using a 100 mm Visual Analog Scale at pre-specified time points. Primary outcome measured the difference in Visual Analog Scale pain scores between the intervention group and the placebo group during intrauterine device placement. Secondary outcomes included Visual Analog Scale pain scores at instillation and 10 minutes after placement, tolerability of the placement pain, as well as acceptability of the analgesia method.RESULTS: We enrolled 151 participants, with 76 assigned to the mepivacaine group and 75 to the placebo group. The mean VAS pain score during IUD placement showed a difference of 13.3 mm (95% CI 5.75-20.87; P<.001): the mepivacaine group had a mean of 53.9 mm (SD 22.8), while the placebo group had a mean of 67.2 mm (SD 22.4). After adjusting for each individual provider's impact, the difference in mean pain scores remained statistically significant (12.2 mm 95% CI 4.85-19.62; P<.001). A greater proportion of women in the intervention group reported tolerable pain during placement with 70/75 participants (93.3%) compared to 53/66 participants (80.3%) in the placebo group (P=.021).CONCLUSION: The intrauterine instillation of mepivacaine results in statistically significant reduction in pain score among nulliparous women during intrauterine device placement. Although the precise clinical impact of this pain reduction method remains uncertain, the observed reduction in pain score result in a higher proportion of women reporting tolerable pain. This finding and the high acceptance as a pain reduction method thereby suggests clinical relevance. Intrauterine instillation of mepivacaine is a possible strategy to increase IUD utilization, particularly among nulliparous women who are at high risk of unintended pregnancy.
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| 8. |
- Envall, Niklas, 1984-, et al.
(författare)
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The use and access to contraception in Sweden during the COVID-19 pandemic period.
- 2023
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Ingår i: European journal of contraception & reproductive health care. - 1362-5187 .- 1473-0782. ; 28:5, s. 275-281
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: Explore perceived access to, the need for, use of, and satisfaction with telemedicine services for contraceptive counselling and prescription-renewal-only during the COVID-19 pandemic, and the impact of the COVID-19 pandemic period on the choice and use of contraceptives.MATERIALS AND METHODS: Internet-based e-survey of Swedish women of fertile age, 16-49 years.RESULTS: In total, 1016 participants completed the survey. Most participants (69.7%) rated their access to contraceptive services 'as usual'. Among the remaining participants, a higher proportion rated their access as deteriorated (73.4%) compared to improved (26.6%; p < 0.001). In total, 38.0% reported a need for contraceptive counselling, whereof 14.0% had used telemedicine for counselling and reported high satisfaction. Telemedicine for prescription-renewal-only was used by 15.1% of the total population. Two per cent reported use of another contraceptive than their intended, whereof long-acting reversible contraceptives were the most common intended method. The proportion of current contraceptive users was lower than in 2017 (62.4% vs 71.1%, p < 0.001), and current users of long-acting reversible contraception decreased from 30.6% to 19.3% (p < 0.001).CONCLUSIONS: During the COVID-19 pandemic period, most women found their access to contraceptive services unaffected, but more women felt that it had deteriorated than improved. The use of telemedicine was low, and the use of contraception overall fell. Efforts are needed to raise awareness of available services, and TM-provided interventions for maintained quality of care and informed decision-making remain to be evaluated.SHORT CONDENSATION The COVID-19 period imposed a change in contraceptive service provision, and efforts are needed to raise awareness of available services, including telemedicine. Access to all contraceptives, including LARCs, is crucial and telemedicine-provided interventions need evaluation.
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| 9. |
- Envall, Niklas, 1984-, et al.
(författare)
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Use of contraception and attitudes towards contraceptive use in Swedish women : an internet-based nationwide survey
- 2022
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Ingår i: European journal of contraception & reproductive health care. - : Informa UK Limited. - 1362-5187 .- 1473-0782. ; 27:5, s. 409-417
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: Explore contraceptive use, unmet need of and attitudes towards contraceptive use in Sweden. Secondly, to investigate knowledge of contraceptives, prevalence and outcomes of unintended pregnancies.MATERIALS AND METHODS: Internet based e-survey of Swedish women aged 16-49. The e-survey contained 49 questions with both spontaneous and multi-choice character on demographics, contraceptive use, knowledge of and attitudes towards contraception, importance of monthly bleeding, and experience of unintended pregnancy. The e-survey was closed when reaching the estimated sample size of 1000 respondents.RESULTS: A total of 1016 women participated, whereof 62.4% used contraception, 31.8% did not and 5.8% had stopped in the last 12 months. Unmet need for contraception was estimated at 17.2%. At least one unintended pregnancy was experienced by 19.9%. All women rated effectiveness as the most important characteristic of a contraceptive method.CONCLUSIONS: Use of contraception in Swedish women remains low, 62.4%, and the unmet need for contraception has increased to 17.2%. Method effectiveness and health benefits of hormonal contraception should be emphasised during contraceptive counselling, and actions are needed to target groups with low use of effective contraception as well as to reach those who never seek contraception.KEY MESSAGE Close to one third of Swedish women do not use contraception and one fifth have experienced at least one unintended pregnancy. Unmet need for contraception is high despite easy access and subsidies for young women.
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| 10. |
- Envall, Niklas, 1984-, et al.
(författare)
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Use of effective contraception 6 months after emergency contraception with a copper intrauterine device or ulipristal acetate - a prospective observational cohort study
- 2016
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 95:8, s. 887-95
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION:Emergency contraception must be followed by the use of an effective method of contraception in order to reduce future risk of unintended pregnancies. Provision of long-acting reversible contraception (LARC) is highly effective in this regard. The aim of our study was to compare use of an effective method of contraception 6 months following insertion of a copper intrauterine device (Cu-IUD) or intake of ulipristal acetate (UPA) for emergency contraception (EC).MATERIAL AND METHODS:Women (n = 79) presenting with need for EC at an outpatient midwifery clinic chose either Cu-IUD or UPA according to preference. Follow up was 3 and 6 months later through telephone interviews. Primary outcome was use of an effective contraceptive method at the 6-month follow up. Secondary outcomes included use of an effective contraceptive method at 3 months follow up and acceptability of Cu-IUD.RESULTS:A total of 30/36 (83.3%) women who opted for Cu-IUD for EC used an effective contraceptive method 6 months after their first visit compared with 18/31 (58.1%) women who opted for UPA (p = 0.03). In the Cu-IUD group 28/36 (77.8%) were still using Cu-IUD at 6 months and 31/36 (86%) stated that they would recommend the Cu-IUD to others as an EC method.CONCLUSION:Significantly more women who chose Cu-IUD for EC used an effective method for contraception at the 6-month follow up. The results of this study support increased use of Cu-IUDs for EC.
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| 11. |
- Hogmark, Sara, et al.
(författare)
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One-year follow up of contraceptive use and pregnancy rates after early medical abortion : Secondary outcomes from a randomized controlled trial of immediate post-abortion placement of intrauterine devices
- 2023
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley-Blackwell. - 0001-6349 .- 1600-0412.
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Intrauterine devices (IUDs) effectively prevent unwanted pregnancies. Little is known about long-term outcomes of women choosing an IUD after early medical abortion.Material and methods: We present secondary outcome data of continuation rates, factors associated with continuation and discontinuation, choice of IUD type, women's satisfaction with IUD, and IUD expulsions, subsequent pregnancies, and abortions within 1 year post-abortion in a randomized, controlled, multicenter trial on IUD placement within 48 hours compared with placement 2-4 weeks after medical abortion up to 63 days' gestation ( NCT03603145).Results: Of the 240 women studied, 112/120 (93.3%) in the intervention group vs 113/120 (94.2%) in the control group completed the 12-month follow-up. The rate of IUD use at 12 months was 84/112 (75%) in the intervention group vs 75/113 (66.4%) in the control group (P = 0.19). Attendance at the IUD placement visit was the only predictor of long-term IUD use (relative risk [RR] = 5.7, 95% confidence interval [CI] 2.03-16.0; P = 0.001). The main reason for choosing an IUD was high contraceptive effectiveness. The most common reasons for IUD discontinuation were bleeding problems and abdominal pain. IUD expulsion was rare and did not differ between groups. Satisfaction among IUD users at 1 year was high (>94%) and the majority of all participants would recommend IUD to a friend (65.8%). Use of no contraception and experience of unprotected intercourse were less common in the intervention group (11/112 [9.8%] vs 25/113 [22.1%], P = 0.02 and 17/112 [15.2%] vs 32/113 [28.3%], P = 0.02, respectively). There was no difference in the rate of subsequent pregnancies and abortions (pregnancies 14/112, 12.5% in the intervention group vs 8/113, 7.1% in the control group, P = 0.19; abortions 5/112, 4.5% vs 3/113, 2.7%, P = 0.5).Conclusions: IUD placement after medical abortion led to high continuation and satisfaction rates with no difference between groups. We found no difference in IUD expulsions after immediate compared with later placement. Unprotected intercourse was significantly less common in the immediate group. In clinical practice, immediate placement of IUDs available free of charge at the abortion clinic is likely to increase attendance to the placement visit and continued use of IUDs after abortion.
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| 12. |
- Hogmark, Sara, et al.
(författare)
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Placement of an intrauterine device within 48 hours after early medical abortion : a randomized controlled trial
- 2023
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Ingår i: American Journal of Obstetrics and Gynecology. - : Elsevier BV. - 0002-9378 .- 1097-6868. ; 228:1, s. 53.e1-53.e9
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Intrauterine devices are safe, well tolerated and known to reduce the risk of unwanted pregnancies. At medical abortion, intrauterine devices are placed at a follow-up visit. Patients who miss this visit risk being left without contraception.OBJECTIVE: To study if placement of an intrauterine device within 48 hours of completed medical abortion up to 63 days' gestation leads to higher user rates at six months after the abortion compared with placement at two to four weeks after abortion. Furthermore, to compare continued use of intrauterine devices, safety and patient satisfaction between groups.STUDY DESIGN: We performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion up to 63 days' gestation and opting for intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2-4 weeks after abortion (control group). We defined the abortion as complete after bleeding of clots and cessation of heavy bleeding following use of misoprostol. Patients answered questionnaires at 3, 6 and 12 months. Primary outcome was use of intrauterine device at 6 months post abortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in non-parametric continuous variables were analyzed by the Mann-Whitney U-test and differences in dichotomous variables were analyzed by Chi square test or Fisher's exact test. A p-value of < 0.05 was considered statistically significant.RESULTS: In the intervention group, 91/111 (82%) used an intrauterine device at six months after the abortion, compared to 87/112 (77.7%) in the control group with a difference in proportion of 4.3% (95% CI -0.062, 0.148, p=0.51). Attendance rate and rate of successful intrauterine device placement were similar between groups. Patients in the intervention group had lower pain scores at placement of the intrauterine device (mean pain score VAS 32.3, SD 29) compared to the control group (mean pain score VAS 43.4, SD 27.9, p=0.002). Patients preferred their allocated time of placement significantly more often in the intervention group, (83/111, 74.8%) compared to the control group (70/114, 61.4%, p=0.03). Use of ultrasound at intrauterine device placement (because of doubts concerning complete abortion) was more common in the intervention group (43/108, 39.8%) compared to the control group (15/101, 14.9%, p<0.001) and in one patient in the control group, a retained gestational sac was found. Three patients in the intervention group and two patients in the control group had a vacuum aspiration. No difference was found in intrauterine device expulsion rates between the groups. In the intervention group, 9/97 (9.3%) patients experienced expulsion during the first six months after abortion and 4/89 (4.5%, p=0.25) in the control group. There were no perforations or infections requiring antibiotic treatment.CONCLUSION: Placement of an intrauterine device within 48 hours after medical abortion at ≤ 63 days' gestation does not lead to higher user rates at six months after the abortion, compared with intrauterine device placement at 2-4 weeks after abortion. When compared with placement at a follow-up visit after 2-4 weeks, intrauterine device placement within 48 hours after early medical abortion appears safe, is preferred by patients and associated with lower pain scores.
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| 13. |
- Hogmark, Sara, et al.
(författare)
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Placement of an intrauterine device within 48 hours after second trimester medical abortion : a randomized controlled trial
- 2024
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Ingår i: American Journal of Obstetrics and Gynecology. - 0002-9378 .- 1097-6868.
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: International guidelines recommend placement of intrauterine devices immediately after second trimester medical abortion, but evidence concerning the optimal time for intrauterine device placement is lacking from clinical trials.OBJECTIVE: We aimed to investigate effectiveness, safety, and acceptability of intrauterine device placement within 48 hours, compared with placement at two to four weeks after second trimester medical abortion. We hypothesized that intrauterine device placement within 48 hours would be superior compared with placement at two to four weeks after the abortion, in terms of the proportion of intrauterine device use after six months, with maintained safety and acceptability.STUDY DESIGN: In this open-label, randomized, controlled, superiority trial, we recruited participants at eight abortion clinics in Sweden. Eligible participants were ≥18 years, requesting medical abortion with gestation ≥85 days and opting for use of a post abortion intrauterine device. Participants were randomized (1:1) to intrauterine device placement either within 48 hours of complete abortion (intervention) or after 2 to 4 weeks (control). Our primary outcome was self-reported use of an intrauterine device after 6 months. Secondary outcomes included expulsion rates, pain at placement, adverse events and complications, acceptability, and subsequent pregnancies and abortions. Differences in non-normal continuous variables were analyzed with the Mann-Whitney U-test and differences in dichotomous variables with the chi square or Fisher's exact tests. A P value <.05 was considered statistically significant. Group differences are presented by modified intention-to-treat and per protocol analyses.RESULTS: Between January 2019, and June 2022, we enrolled 179 participants, of whom 90 were assigned to intervention and 89 to control. Enrolment was prematurely stopped after an interim analysis exceeded a predefined intrauterine device expulsion rate of 20%. By modified intention-to-treat, use of intrauterine device after 6 months was 50.7% (34/67) in the intervention group compared to 71.6% (48/67) in the control group (proportion difference 20.9%; 95% confidence interval 4.4%-35.9%; P=.02). The intrauterine device expulsion rate was 30.1% (22/73) in the intervention group versus 2.9% (2/70; P <.001) in the control group. Other adverse events were rare and patient acceptability was high in both groups.CONCLUSION: Intrauterine device placement within 48 hours after second trimester medical abortion was non-superior in terms of the proportion of intrauterine device use after 6 months when compared with placement after 2 to 4 weeks. Placement within 48 hours after second trimester abortion can be used in selected individuals after counselling on expulsion risk.
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- Hogmark, Sara, et al.
(författare)
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Provision of long-acting reversible contraception at surgical abortion-A cross-sectional nationwide register study
- 2022
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 101:1, s. 77-83
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Provision of long-acting reversible contraception (LARC) at surgical abortion is safe, practical, and leads to higher user rates than does delayed provision. The aim of this study was to explore whether provision of LARC at surgical abortion is associated with known risk factors for subsequent abortions and inconsistent use of contraception, including sociodemographic factors and psychiatric disorders.Material and methods: This was a register-based cross-sectional study of 6251 women having a surgical abortion in Sweden. Data were collected from National health and population registers. Women with procedure codes for surgical abortion were identified in the National Patient Register from October 2016 to December 2018. Information from Statistics Sweden, the National Patient Register, and the Swedish prescribed drug register on sociodemographic factors, psychiatric disorders, and dispensed LARC was added and linked on an individual level. Associations of sociodemographic factors and psychiatric disorders with LARC provision were explored with generalized logit mixed models and presented as crude and adjusted odds ratios with 95% confidence intervals (CIs).Results: The overall rate of LARC provision at the time of the abortion was 2515/6251 (40.2%). Younger age and lower level of education were associated with an increased likelihood of LARC provision. In the study population, 2624/6251 (42.0%) patients had a pre- or post-abortion psychiatric disorder, a factor associated with an increased likelihood of LARC provision compared with women with no such disorders (adjusted odds ratio 1.21; 95% CI 1.08-1.34). The highest rates and odds were seen among women with personality, substance use, and/or neurodevelopmental disorders and among women with multiple psychiatric disorders.Conclusions: Sociodemographic risk factors and psychiatric disorders were associated with increased LARC provision at surgical abortion, indicating that women at high risk of unwanted pregnancies are provided with effective contraception. Still, less than half of all women undergoing surgical abortion were provided with LARC, suggesting that contraceptive access and counseling prior to a surgical abortion can be improved.
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