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  • 1.
    Envall, Niklas
    et al.
    Dalarna University, School of Health and Welfare, Sexual Reproductive Perinatal Health. Danderyd Hospital, Karolinska Institutet, Stockholm; Karolinska Institutet, Stockholm.
    Elgemark, Karin
    Danderyd Hospital, Karolinska Institutet, Stockholm; Danderyd Hospital, Stockholm.
    Kopp Kallner, Helena
    Danderyd Hospital, Karolinska Institutet, Stockholm; Karolinska Institutet, Stockholm; Danderyd Hospital, Stockholm.
    Mepivacaine instillation for pain reduction during intrauterine device placement in nulliparous women: a double-blinded randomized trial2024In: American Journal of Obstetrics and Gynecology, ISSN 0002-9378, E-ISSN 1097-6868, article id S0002-9378(24)00624-0Article in journal (Refereed)
    Abstract [en]

    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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  • 2.
    Hogmark, Sara
    et al.
    Danderyd Hospital, Stockholm; Karolinska Institutet, Stockholm; Center for Clinical Research Dalarna, Uppsala University, Falun.
    Lichtenstein Liljeblad, Karin
    Danderyd Hospital, Stockholm; Karolinska Institutet, Stockholm.
    Envall, Niklas
    Dalarna University, School of Health and Welfare, Sexual Reproductive Perinatal Health. Danderyd Hospital, Stockholm; Karolinska Institutet, Stockholm.
    Gemzell-Danielsson, Kristina
    Karolinska Institutet, Stockholm; Karolinska University Hospital Stockholm.
    Kopp Kallner, Helena
    Danderyd Hospital, Stockholm; Karolinska Institutet, Stockholm.
    Placement of an intrauterine device within 48 hours after early medical abortion: a randomized controlled trial2023In: American Journal of Obstetrics and Gynecology, ISSN 0002-9378, E-ISSN 1097-6868, Vol. 228, no 1, p. 53.e1-53.e9Article in journal (Refereed)
    Abstract [en]

    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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  • 3.
    Hogmark, Sara
    et al.
    Danderyd Hospital, Karolinska Institutet, Stockholm; Center for Clinical Research Dalarna, Uppsala University, Falun; Falu Hospital, Falun.
    Rydelius, Johanna
    University of Gothenburg, Gothenburg.
    Envall, Niklas
    Dalarna University, School of Health and Welfare, Sexual Reproductive Perinatal Health. Danderyd Hospital, Karolinska Institutet, Stockholm; Karolinska Institutet, Stockholm.
    Teleman, Pia
    Lund University, Lund; Skane University Hospital, Lund.
    Gemzell-Danielsson, Kristina
    Karolinska Institutet, Stockholm; Karolinska University Hospital, Stockholm.
    Kallner, Helena Kopp
    Danderyd Hospital, Karolinska Institutet, Stockholm; University of Gothenburg, Gothenburg.
    Placement of an intrauterine device within 48 hours after second trimester medical abortion: a randomized controlled trial2024In: American Journal of Obstetrics and Gynecology, ISSN 0002-9378, E-ISSN 1097-6868Article in journal (Refereed)
    Abstract [en]

    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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  • 4.
    Lindgren, Helena
    et al.
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    Hildingsson, Ingegerd
    Haglund, Bengt
    Rådestad, Ingela J
    Characteristics of women giving birth at home in Sweden: a national register study.2006In: American Journal of Obstetrics and Gynecology, ISSN 0002-9378, E-ISSN 1097-6868, Vol. 195, no 5, p. 1366-1372Article in journal (Refereed)
    Abstract [en]

    Objective: The objective of the study was to estimate the proportion of planned home births in Sweden and to identify maternal characteristics of women giving birth at home. Study design: This case-control study included register data of births from 1992 to 2001 in 352 women giving birth at home and 1760 women giving birth in a hospital. Results: Four hundred thirty-nine out-of-hospital births were found during the study period (0.5%). The proportion of planned home births was less than 0.4%. Women with home birth were more likely to have 4 children or more (odds ratio 3.7 [1.4 to 9.9]), be born in a European country outside Sweden (odds ratio 3.5 [1.8 to 6.8]), have a family income below the median (odds ratio 2.9 [2.0 to 4.1]), not work outside the home (odds ratio 2.4 [1.7 to 3.5]), have a high level of education (odds ratio 2.1 [1.5 to 3.0]), and be older than 35 years (odds ratio 1.7 [1.1 to 2.5]). Conclusion: Women with planned home births appear to be a group having a different lifestyle, compared with Swedish women in general.

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