1. |
- Envall, Niklas, 1984-, et al.
(author)
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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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In: Contraception. - : Elsevier BV. - 0010-7824 .- 1879-0518. ; 99:6, s. 335-39
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Journal article (peer-reviewed)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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2. |
- Bergendahl, Sandra, et al.
(author)
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Lateral episiotomy versus no episiotomy to reduce obstetric anal sphincter injury in vacuum-assisted delivery in nulliparous women : Study protocol on a randomised controlled trial
- 2019
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In: BMJ Open. - : BMJ. - 2044-6055. ; 9:3
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Journal article (peer-reviewed)abstract
- Introduction Obstetric anal sphincter injury (OASIS) occurs in 5%-7% of normal deliveries and increases with vacuum extraction (VE) to 12%-14% in nulliparous women in Sweden. Lateral/mediolateral episiotomy may reduce the prevalence of OASIS at VE in nulliparous women. The current use of episiotomy is restrictive. The protective effect and consequences are uncertain. This trial will investigate if lateral episiotomy can reduce the prevalence of OASIS and assess short-term and long-term effects. Methods and analysis This is a multicentre randomised controlled trial of lateral episiotomy versus no episiotomy in nulliparous women with a singleton, live fetus, after gestational week 34+0 with indication for VE. A lateral episiotomy of 4 cm is cut at crowning, 1-3 cm from the midline, at a 60° angle. The primary outcome is OASIS by clinical diagnosis analysed according to intention to treat. To demonstrate a 50% reduction in OASIS prevalence (from 12.4% to 6.2%), 710 women will be randomised at a 1:1 ratio. Secondary outcomes are pain, blood loss, other perineal injuries, perineal complications, Apgar score, cord pH and neonatal complications. Web-based questionnaires at baseline, 2 months, 1 and 5 years will be used to assess pain, incontinence, prolapse, sexual function, quality of life and childbirth experience. A subset of women will receive follow-up by pelvic floor sonography and pelvic examination. Mode of delivery and recurrence of OASIS/episiotomy in subsequent pregnancies will be assessed at 5 and 10 years using register data. Ethics and dissemination The trial is open for enrolment. The trial has received ethical approval from the Regional Ethical Review Board of Stockholm and full funding from the Swedish Research Council. Women are interested in participation. The predominant restrictive view on episiotomy may limit recruitment. Results are of global interest and will be disseminated in peer-reviewed journals and at international congresses.
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3. |
- Envall, Niklas, 1984-, et al.
(author)
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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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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 95:8, s. 887-95
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Journal article (peer-reviewed)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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4. |
- Kallner, Helena Kopp, et al.
(author)
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DIAGNOSTIC COLPOSCOPIC ACCURACY BY THE GYNOCULAR AND A STATIONARY COLPOSCOPE
- 2015
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In: International Journal of Technology Assessment in Health Care. - 0266-4623 .- 1471-6348. ; 31:3, s. 181-187
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Journal article (peer-reviewed)abstract
- Objectives: The aim of this study was to evaluate the diagnostic accuracy of sensitivity and specificity of cervical lesions by the low-cost, portable Gynocular colposcope and a stationary colposcope, in women referred for colposcopy with abnormal cervical cytology. Methods: A randomized cross-over clinical trial for evaluating the diagnostic accuracy in detecting cervical lesions by the Gynocular and a stationary colposcope. The Swede score systematic colposcopy system was used for evaluation of colposcopic abnormalities. Directed punch biopsy and excisional cone biopsy were used as the gold-standard by histologically confirmed high grade cervical lesions CIN2+ (CIN2, CIN3, CIN3+). In total, 123 women referred for colposcopy due to abnormal cervical cytology were recruited at the Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden. The percentage agreement and the kappa statistic were calculated for Swede score by the Gynocular and a stationary colposcope. Swede scores were compared with the results from directed punch biopsy and excisional cone biopsy. Results: The Gynocular and the stationary colposcope had a high agreement of Swede scores with a Kappa statistic of 0.947, p < .0001. Punch biopsy diagnosed CIN2+ (CIN2, CIN3, and invasive cancer) in 44 (35.7 percent) women while cytology detected CIN2+ in 34 (27.6 percent) women. There were no significant differences of the sensitivity and specificity for different Swede scores by the Gynocular or a stationary colposcope in detecting CIN 2+. Conclusions: There were no significant differences in sensitivity or specificity in detecting cervical lesions by the Gynocular or stationary colposcope. The Gynocular is as accurate in diagnosing cervical lesions as a stationary colposcope.
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5. |
- Kopp Kallner, Helena, et al.
(author)
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Use of Contraception and Attitudes towards Contraceptive Use in Swedish Women : A Nationwide Survey
- 2015
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In: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 10:5
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Journal article (peer-reviewed)abstract
- Objective: To describe contraceptive use and attitudes towards contraceptive use in Sweden which has the highest abortion rate in Western Europe. Secondary objectives were to investigate knowledge of contraceptive methods and outcomes of unplanned and unwanted pregnancies.Design: Telephone survey.Setting: National survey of women living in Sweden.Population: Women between 16 and 49 years.Methods: The survey contained 22 questions with free text and multi choice answers on demographics, contraceptive use, knowledge of and attitudes towards contraception, the importance of monthly bleeding and experience of unintended pregnancy.Main Outcome Measures: Distribution of use of contraceptive methods and non-use of contraception among Swedish women. Prevalence and outcome of unintended pregnancies.Results: A total of 1001 women participated in the survey. Of all women, 721/1001 (72.1%) currently used contraception whereas 268/1001 (26.8%) women did not. Long acting reversible contraception, (LARC; implant and intra uterine contraception) was used by 24.3% of women. The unmet need of contraception in Sweden was estimated at 8.9% (89/1001 women). 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: Sweden has a large unmet need for contraception. Furthermore, a large proportion of women have experienced at least one unintended pregnancy. Increasing contraceptive use and promotion of LARC is a possible way forward in the effort to reduce the rates of unwanted pregnancies.
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6. |
- Scherwitzl, Elina Berglund, et al.
(author)
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Short- and long-term effect of contraceptive methods on fecundity
- 2019
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In: European journal of contraception & reproductive health care. - : TAYLOR & FRANCIS LTD. - 1362-5187 .- 1473-0782. ; 24:4, s. 260-265
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Journal article (peer-reviewed)abstract
- Objective: The aim of the study was to compare the effect of previously used contraceptive methods on women's short- and long-term fecundity. Use of hormonal contraception (HC) was compared with the use of a contraceptive mobile application (app). Methods: This real-life prospective observational study comprised 2874 women who were attempting to become pregnant using the Natural Cycles mobile app to monitor their fertility. The women registered to use the app between August 2014 and June 2016 with the intention of planning a pregnancy and had previously either used the same app to prevent pregnancy or had recently discontinued HC use. We calculated the average time to pregnancy (TTP) for all women who became pregnant during the study and performed Kaplan-Meier life-table analysis to examine the cumulative probabilities of pregnancy for all women in the study. Results: The average TTP was 2.3 (95% confidence interval [CI] 2.1, 2.4) and 3.7 (95% CI 3.4, 3.9) cycles for women who had previously used Natural Cycles and HC, respectively. The time to reach 30% pregnancy probability for women previously on HC was 1.6 (95% CI 1.5, 1.8) times longer than for women previously using Natural Cycles. There was no significant difference in the 13 cycle cumulated pregnancy probability between the two groups. Conclusion: The results show that fertility awareness-based methods of contraception increase short-term pregnancy rates relative to HC, but have no effect on long-term pregnancy rates.
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7. |
- Sjöström, Susanne, et al.
(author)
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Medical Abortion Provided by Nurse-Midwives or Physicians in a High Resource Setting : A Cost-Effectiveness Analysis
- 2016
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In: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 11:6
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Journal article (peer-reviewed)abstract
- Objective The objective of the present study is to calculate the cost-effectiveness of early medical abortion performed by nurse-midwifes in comparison to physicians in a high resource setting where ultrasound dating is part of the protocol. Non-physician health care professionals have previously been shown to provide medical abortion as effectively and safely as physicians, but the cost-effectiveness of such task shifting remains to be established. Study design A cost effectiveness analysis was conducted based on data from a previously published randomized-controlled equivalence study including 1180 healthy women randomized to the standard procedure, early medical abortion provided by physicians, or the intervention, provision by nurse-midwifes. A 1.6% risk difference for efficacy defined as complete abortion without surgical interventions in favor of midwife provision was established which means that for every 100 procedures, the intervention treatment resulted in 1.6 fewer incomplete abortions needing surgical intervention than the standard treatment. The average direct and indirect costs and the incremental cost-effectiveness ratio (ICER) were calculated. The study was conducted at a university hospital in Stockholm, Sweden. Results The average direct costs per procedure were EUR 45 for the intervention compared to EUR 58.3 for the standard procedure. Both the cost and the efficacy of the intervention were superior to the standard treatment resulting in a negative ICER at EUR -831 based on direct costs and EUR -1769 considering total costs per surgical intervention avoided. Conclusion Early medical abortion provided by nurse-midwives is more cost-effective than provision by physicians. This evidence provides clinicians and decision makers with an important tool that may influence policy and clinical practice and eventually increase numbers of abortion providers and reduce one barrier to women's access to safe abortion.
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8. |
- Skoglund, Charlotte, et al.
(author)
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Association of Attention-Deficit/Hyperactivity Disorder With Teenage Birth Among Women and Girls in Sweden
- 2019
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In: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 2:10
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Journal article (peer-reviewed)abstract
- IMPORTANCE Attention-deficit/hyperactivity disorder (ADHD) is associated with a plethora of adverse health outcomes throughout life. While Swedish specialized youth clinics have carefully and successfully targeted risk of unplanned pregnancies in adolescents, important risk groups, such as women and girls with ADHD, might not be identified or appropriately assisted by these interventions. OBJECTIVES To determine whether women and girls with ADHD are associated with increased risk of teenage birth compared with their unaffected peers and to examine the association of ADHD with risk factors for adverse obstetric and perinatal outcomes, such as smoking, underweight or overweight, and substance use disorder. DESIGN, SETTING, AND PARTICIPANTS This nationwide cohort study included data from 6 national longitudinal population-based registries in Sweden. All nulliparous women and girls who gave birth in Sweden between January 1, 2007, and December 31, 2014, were included. Data analyses were conducted from October 7, 2018, to February 8, 2019. EXPOSURES Women and girls treated with stimulant or nonstimulant medication for ADHD (Anatomic Therapeutic Chemical classification code N06BA) in the Swedish Prescribed Drug Register between July 1, 2005, and December 31, 2014. MAIN OUTCOMES AND MEASURES Maternal age at birth. Secondary outcome measures were body mass index, smoking habits, and psychiatric comorbidities. RESULTS Among 384 103 nulliparous women and girls aged 12 to 50 years who gave birth between 2007 and 2014 included in the study, 6410 (1.7%) (mean [SD] age, 25.0 [5.5] years) were identified as having ADHD. The remaining 377 693 women and girls without ADHD (mean [SD] age, 28.5 [5.1] years) served as the control group. Teenage deliveries were more common among women and girls with ADHD than among women and girls without ADHD (15.3% vs 2.8%; odds ratio [OR], 6.23 [95% CI, 5.80-6.68]). Compared with women and girls without ADHD, those with ADHD were more likely to present with risk factors for adverse obstetric and perinatal outcomes, including smoking during the third trimester (OR, 6.88 [95% CI, 6.45-7.34]), body mass index less than 18.50 (OR, 1.29 [95% CI, 1.12-1.49]), body mass index more than 40.00 (OR, 2.01 [95% CI, 1.60-2.52]), and alcohol and substance use disorder (OR, 20.25 [95% CI, 18.74-21.88]). CONCLUSIONS AND RELEVANCE This study found that women and girls with ADHD were associated with an increased risk of giving birth as teenagers compared with their unaffected peers. The results suggest that standard of care for women and girls with ADHD should include active efforts to prevent teenage pregnancies.
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