| 1. |
- Alkmark, Mårten, et al.
(författare)
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Efficacy and safety of oral misoprostol vs transvaginal balloon catheter for labor induction : An observational study within the SWEdish Postterm Induction Study (SWEPIS)
- 2021
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons. - 0001-6349 .- 1600-0412. ; 100:8, s. 1463-1477
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Induction of labor is increasing in the world. A common indication for Induction of labor is late term and postterm pregnancy at 41 gestational week and thereafter. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0-1 gestational weeks.MATERIAL AND METHODS: In this observational study, based on data from Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1 213 women with a low-risk singleton pregnancy at 41 to 42 gestational weeks were induced with oral misoprostol (n=744) or transvaginal balloon catheter (n=469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24 hours and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time-to-vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analogue scale. We present crude and adjusted mean differences and relative risks (RR) with 95% confidence interval (CI). Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score.RESULTS: Vaginal delivery within 24 hours was significantly lower in the misoprostol compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 [95% CI 0.64; 0.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31; 1.89]; maternal composite (2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58; 4.97]). Adjusted mean time-to-vaginal delivery was increased by 3.8 hours (95% CI 1.3; 6.2) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups.CONCLUSION: Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24 hours and a longer time-to-vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.
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| 2. |
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| 3. |
- Ankarcrona, Victoria, et al.
(författare)
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Attitudes and knowledge regarding episiotomy use and technique in vacuum extraction : A web-based survey among doctors in Sweden
- 2022
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Ingår i: European Journal of Obstetrics, Gynecology, and Reproductive Biology. - : Elsevier. - 0301-2115 .- 1872-7654. ; 269, s. 62-70
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Correct episiotomy use and technique may prevent obstetric anal sphincter injuries. We aimed to explore the attitudes, use, and technique regarding episiotomy among doctors in Sweden, and their willingness to contribute to a randomized controlled trial of lateral episiotomy or no episiotomy in vacuum extraction in nulliparous women.Study design: A web-based survey was sent to members of the Swedish Society of Obstetrics and Gynecology (n = 2140). The survey included 31 questions addressing personal characteristics, use of episiotomy, a two-dimensional picture on which the respondents drew an episiotomy, and questions regarding attitudes towards episiotomy and participation in a randomized controlled trial. We calculated the proportion of supposedly protective episiotomies (fulfilling criteria of a lateral or mediolateral episiotomy and a length >= 30 mm). We compared the results between obstetricians, gynecologists, and residents using Chi-square and Kruskal-Wallis tests for differences between groups, and logistic regression to estimate the odds ratio (OR) of drawing a protective episiotomy.Results: We received 432 responses. Doctors without a vacuum delivery in the past year were excluded, leaving 384 respondents for further analyses. In all, 222 (57.8%) doctors reported use of episiotomy in<50% of vacuum extractions. We obtained 308 illustrated episiotomies with a median angle of 53 degrees, incision point distance from the midline of 21 mm, and length of 36 mm, corresponding to a lateral episiotomy. Few doctors combined these parameters correctly resulting in 167 (54.2%) incorrectly drawn episiotomies. Residents drew shorter episiotomies than obstetricians and gynecologists. Doctors ranked episiotomy the least important intervention to prevent obstetric anal sphincter injuries in vacuum extraction. Doctors contributing to an ongoing randomized controlled trial of lateral episiotomy or no episiotomy in vacuum extraction were more able to draw a protective episiotomy (OR 3.69, 95% confidence interval 1.94-7.02).Conclusions: Doctors in Sweden reported restrictive use of episiotomy in vacuum extraction and depicted lateral type episiotomies, although the majority were incorrectly drawn. Preventive episiotomy was ranked of low importance. Our results imply a need for education, training, and guidelines to increase uptake of correct episiotomy technique, which could result in improved prevention of obstetric anal sphincter injuries.
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| 4. |
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| 5. |
- Ankarcrona, Victoria, et al.
(författare)
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Delivery outcome after trial of labor in nulliparous women 40 years or older-A nationwide population-based study
- 2019
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : WILEY. - 0001-6349 .- 1600-0412. ; 98:9, s. 1195-1203
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Tidskriftsartikel (refereegranskat)abstract
- Introduction The number of women postponing childbirth until an advanced age is increasing. Our aim was to study the outcome of labor in nulliparous women >= 40 years, compared with women 25-29 years, after both spontaneous onset and induction of labor. Material and methods The nationwide population-based Swedish Medical Birth Register was used to study the perinatal outcome in nulliparous women with a singleton, term (gestational weeks 37-44), live fetus in cephalic presentation and a planned vaginal delivery from 1992 to 2011. We included 7796 nulliparous women >= 40 years and 264 262 nulliparous women 25-29 years. Prevalence and risk of intrapartum cesarean section, operative vaginal delivery, obstetric anal sphincter injury and a 5-minute Apgar score <7 were calculated for women >= 40 years stratified for spontaneous onset and induction of labor, using women 25-29 years as the reference in both strata. Crude and adjusted odds ratios (aOR) were calculated by unconditional logistic regression and presented with 95% confidence intervals (CI). Results Overall, 79% of women >= 40 years with a trial of labor reached a vaginal delivery. After spontaneous onset, intrapartum cesarean section was performed in 15.4% of women >= 40 years compared with 5.4% of women 25-29 years (aOR 3.07, 95% CI 2.81-3.35). Operative vaginal delivery was performed in 22.3% of women >= 40 years compared with 14.2% of women 25-29 years (aOR 1.71, 95% CI 1.59-1.85). After induction of labor, an intrapartum cesarean section was performed in 37.2% women >= 40 years compared with 20.2% women 25-29 years (aOR 2.51, 95% CI 2.24-2.81). Operative vaginal delivery was performed in 22.6% of women >= 40 years compared with 18.4% women 25-29 years (aOR 1.45, 95% CI 1.28-1.65). The risk of obstetric anal sphincter injury or a 5-minute Apgar score <7 was not increased in women >= 40 years, regardless of onset of labor. Conclusions Trial of labor ended in vaginal delivery in 79% of nulliparous women >= 40 years. The risks of intrapartum cesarean section and operative vaginal delivery were higher in women >= 40 years compared with women 25-29 years, after both spontaneous onset and induction of labor. The risk of obstetric anal sphincter injury or a 5-minute Apgar score <7 was not increased.
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| 6. |
- Ankarcrona, Victoria, et al.
(författare)
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Episiotomy in vacuum extraction, do we cut the levator ani muscle? : A prospective cohort study
- 2022
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Ingår i: International Urogynecology Journal. - : Springer Nature. - 0937-3462 .- 1433-3023. ; 33:12, s. 3391-3399
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Tidskriftsartikel (refereegranskat)abstract
- Introduction and hypothesis Vaginal delivery may lead to levator ani muscle (LAM) injury or avulsion. Episiotomy may reduce obstetric anal sphincter injury in operative vaginal delivery, but may increase the risk of LAM injury. Our aim was to assess whether lateral episiotomy in vacuum extraction (VE) in primiparous women causes LAM injury. Methods A prospective cohort study of 58 primiparous women with episiotomy nested within an ongoing multicenter randomized controlled trial of lateral episiotomy versus no episiotomy in VE (EVA trial) was carried out in Sweden. LAM injury was evaluated using 3D endovaginal ultrasound 6-12 months after delivery and Levator Ani Deficiency (LAD) score. Episiotomy scar properties were measured. Characteristics were described and compared using Chi-squared tests. We stipulated that if a lateral episiotomy cuts the LAM, >= 50% would have a LAM injury. Among those, >= 50% would be side specific. We compared the observed prevalence with a test of one proportion. Results Twelve (20.7%, 95% CI 10.9-32.9) of 58 women had a LAD (p < 0.001, compared with the stipulated 50%). Six (50.0%, 95% CI 21.1% to 78.9%) of 12 women had a LAD on the episiotomy side, including those with bilateral LAD (p = 1.00). Two (16.7%, 95% CI 2.1% to 48.4%) of 12 women had a LAD exclusively on the episiotomy side (p = 0.02). Conclusions There was no excessive risk of cutting the LAM while performing a lateral episiotomy. LAD was not seen in women with episiotomies shorter than 18 mm.
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| 7. |
- Ankarcrona, Victoria, et al.
(författare)
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Obstetric anal sphincter injury after episiotomy in vacuum extraction: an epidemiological study using an emulated randomized trial approach
- 2021
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Ingår i: BJOG : an international journal of obstetrics and gynaecology. - : Wiley. - 1471-0528 .- 1470-0328. ; 128:10, s. 1663-1671
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Tidskriftsartikel (refereegranskat)abstract
- To emulate a randomized controlled trial investigating if lateral or mediolateral episiotomy compared to no episiotomy reduces the prevalence of obstetric anal sphincter injury (OASIS) in nulliparous women delivered with vacuum extraction.A population-based observational study.Sweden.63 654 nulliparous women delivered with vacuum extraction derived from the Swedish Medical Birth Register 2000-2011, with a live singleton baby without known malformations in cephalic presentation in gestational week ≥34+0, and subject to lateral or mediolateral episiotomy or no episiotomy.The effect of episiotomy was calculated using a causal doubly robust estimation method based on propensity scores. Results are presented as the average treatment effect and numbers needed to treat (NNT).OASIS (third- and fourth-degree perineal injury) in nulliparous women delivered with vacuum extraction.Episiotomy was associated with a reduction in OASIS from 15.5% to 11.8%, average treatment effect -3.66% (95% CI -4.31 to -3.01) and NNT 27. Third-degree perineal injuries were reduced from 14.0% to 10.9% (-3.08, 95% CI -3.71 to -2.42) with NNT 32. Fourth-degree perineal injuries were reduced from 1.6% to 1.0 % (-0.58%, 95% CI -0.79 to -0.37) with NNT 172.Lateral or mediolateral episiotomy reduced the prevalence of OASIS in nulliparous women delivered with vacuum extraction, compared to women with no episiotomy.
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| 8. |
- Bergendahl, Sandra, et al.
(författare)
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Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA) : multicentre, open label, randomised controlled trial
- 2024
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Ingår i: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 385, s. e079014-
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction. Design: A multicentre, open label, randomised controlled trial.Setting: Eight hospitals in Sweden, 2017-23.Participants: 717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were randomly assigned (1:1) to lateral episiotomy or no episiotomy using sealed opaque envelopes. Randomisation was stratified by study site.Intervention: A standardised lateral episiotomy was performed during the vacuum extraction, at crowning of the fetal head, starting 1-3 cm from the posterior fourchette, at a 60° (45-80°) angle from the midline, and 4 cm (3-5 cm) long. The comparison was no episiotomy unless considered indispensable.Main outcome measures: The primary outcome of the episiotomy in vacuum assisted delivery (EVA) trial was obstetric anal sphincter injury, clinically diagnosed by combined visual inspection and digital rectal and vaginal examination. The primary analysis used a modified intention-to-treat population that included all consenting women with attempted or successful vacuum extraction. As a result of an interim analysis at significance level P<0.01, the primary endpoint was tested at 4% significance level with accompanying 96% confidence interval (CI).Results: From 1 July 2017 to 15 February 2023, 717 women were randomly assigned: 354 (49%) to lateral episiotomy and 363 (51%) to no episiotomy. Before vacuum extraction attempt, one woman withdrew consent and 14 had a spontaneous birth, leaving 702 for the primary analysis. In the intervention group, 21 (6%) of 344 women sustained obstetric anal sphincter injury, compared with 47 (13%) of 358 women in the comparison group (P=0.002). The risk difference was -7.0% (96% CI -11.7% to -2.5%). The risk ratio adjusted for site was 0.47 (96% CI 0.23 to 0.97) and unadjusted risk ratio was 0.46 (0.28 to 0.78). No significant differences were noted between groups in postpartum pain, blood loss, neonatal outcomes, or total adverse events, but the intervention group had more wound infections and dehiscence.Conclusions: Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury. Trial registration: ClinicalTrials.gov NCT02643108.
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| 9. |
- Bergendahl, Sandra, et al.
(författare)
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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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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 9:3
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Tidskriftsartikel (refereegranskat)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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| 10. |
- Brismar Wendel, Sophia, et al.
(författare)
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Förlossningsbristningar
- 2021. - 3
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Ingår i: Obstetrik. - Lund : Studentlitteratur AB. - 9789144142609 ; , s. 601-614
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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| 11. |
- Brismar Wendel, Sophia
(författare)
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HPV genotyping and potential progression markers in cervical intraepithelial neoplasia : clinical and diagnostic impact
- 2009
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The aim of this thesis is to identify clinically useful early molecular markers to predict progression to carcinoma in women with preinvasive lesions of the cervix, for the purpose of improving care of these women and enabling more individualized treatment. In order to define the human papillomavirus (HPV) types in minor cytological abnormalities, 343 liquid-based cytology (LBC) samples with atypical squamous cells of uncertain significance (ASCUS) and with low-grade squamous intraepithelial lesions (LSIL) were genotyped using Linear Array. We found high-risk (HR-) HPV in 71% of LSIL and 49% of ASCUS cases (p<0.001). HR-HPV prevalence was similar in LSIL and ASCUS cases among women over 25 years. Younger (<25 years) and older (>50 years) women had higher prevalence of HR-HPV and multiple infections (p=0.01). HPV16 was found in 23% and HPV18 in 10% (p<0.001) of HPV-positive women. To test the utility of HPV genotyping in post-surgical monitoring, we genotyped cones of 90 women and follow-up samples after conization, and evaluated cytological results from two consecutive visits. Margin status and presence of CIN3+ in the cone were poor predictors of treatment outcome (sensitivity <50%). Presence of any probable HR/HR-HPV (18 types) predicted all residual high-grade SIL/ cervical intraepithelial neoplasia (CIN) 2 or worse with 73% specificity. Consideration of only 13 HR-HPV types showed equal sensitivity, but higher specificity (86%, p<0.01). True persistent infection detected high-grade residual disease with 60% sensitivity and 95% specificity, resulting in a positive predictive value (PPV) of 43%. We also assessed the utility of p16INK4a immunocytochemical detection of dysplastic cells in 118 samples from patients referred for further testing because of cytological abnormality. Intensity of p16INK4a staining correlated well with CIN grade, particularly when diagnosis was based on simultaneous routine cytology (p<0.001, Rho 0.70). Immunostaining for p16INK4a was feasible in clinical practice and helped to distinguish premalignant cells from reactive cells. To map local immune responses to HPV, we analyzed expression of several immune markers using real -time RT-PCR in cervical biopsies from 24 female volunteers who had been genotyped for HPV. No difference between the 11 HPV-positive and 13 HPV-negative women was found for mRNA expression of any of the immune markers. Surprisingly, levels of the B cell marker CD19 were elevated among women using hormonal contraception (p<0.05). HPV genotyping revealed age-dependent patterns of HPV infections in LSIL and ASCUS cases. We propose triage HPV testing of LSIL after 30 years of age. Genotyping after conization substantially increased PPV, but with loss in sensitivity. General HR-HPV testing will identify all recurrent or residual high-grade CIN. Demonstration of p16INK4a accumulation in the cell nucleus is a simple way to enhance presence of dysplastic cells and to distinguish these from reactive atypia. HPV infection per se does not evoke local immune response as measured by semi-quantitative RT-PCR. Hormonal contraception may influence B cell activity in the cervix. Further studies are needed to identify potential progression markers.
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| 12. |
- Brismar Wendel, Sophia, et al.
(författare)
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The association between episiotomy or OASIS at vacuum extraction in nulliparous women and subsequent prelabor cesarean delivery : A nationwide observational study
- 2023
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 102:3, s. 378-388
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Severe perineal injuries at childbirth affect women's postnatal health, including future childbirths. First births with vacuum extraction carry an increased risk of obstetric anal sphincter injuries (OASIS). Lateral or mediolateral episiotomy at vacuum extraction may decrease the risk of OASIS. Our aim was to assess whether lateral or mediolateral episiotomy, or OASIS, at vacuum extraction in nulliparous women is associated with prelabor cesarean delivery in the subsequent childbirth.Material and methods: This is a nationwide observational study using data from the Swedish Medical Birth Register, including women having a first birth with vacuum extraction and a second birth in 2000–2014. Both births were live, single, cephalic, ≥34 gestational weeks without malformations. The association between episiotomy or OASIS in the first birth and prelabor cesarean delivery in the second birth was examined using univariate and multivariate logistic regression with inverse probability of treatment weighting, and interaction analysis. Main outcome measure was prelabor cesarean delivery in the second birth.Results: In total, 44 656 women with vacuum extraction at their first birth were included. The rate of prelabor cesarean delivery in the second birth was 5.9% (824 of 13 950) in women with episiotomy, compared with 6.0% (1830 of 30 706) in women without episiotomy. Thus, women with episiotomy did not have an increased risk of prelabor cesarean delivery (adjusted odds ratio [aOR] 1.00, 95% confidence interval [95% CI] 0.83–1.20) compared with women without episiotomy. For comparison, the rate of prelabor cesarean delivery in the second birth was 20.6% (1275 of 6176) in women with OASIS, compared with 3.6% (1379 of 38 480) in women without OASIS (aOR 6.57, 95% CI 5.97–7.23). There was no interaction between episiotomy and OASIS.Conclusions: Lateral or mediolateral episiotomy at vacuum extraction in nulliparous women did not increase the risk of prelabor cesarean delivery in the subsequent childbirth. OASIS increased the odds of prelabor cesarean delivery more than sixfold.
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| 13. |
- Carlsson, Ylva, 1975, et al.
(författare)
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COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study.
- 2021
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 11:9
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Tidskriftsartikel (refereegranskat)abstract
- There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic.This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews.Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals.NCT04433364.
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| 14. |
- Ericson, Jenny, et al.
(författare)
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Women's experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery : a qualitative study
- 2021
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Ingår i: Trials. - : BioMed Central (BMC). - 1745-6215. ; 22:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Information about and invitation to participate in a clinical trial involving an intervention during childbirth may cause fear or worry in pregnant women. The aim of this study was to describe nulliparous women's experiences of receiving an invitation to participate in a randomized controlled trial (RCT) of lateral episiotomy versus no episiotomy in vacuum-assisted delivery (EVA trial). Methods: This qualitative study was nested in the ongoing EVA trial. Data were collected through semistructured telephone interviews with 23 women regarding their experiences of the information and invitation to participate in the EVA trial. Interviews were audio-recorded and transcribed verbatim. A qualitative content analysis was used to analyse the interview contents. Results: Three main experience categories were identified among the participants. "Timing of trial information and understanding" revealed that women preferred to obtain information about the trial early on during pregnancy. "Reasons to consent to or decline participation in the trial" encompassed a variety of reasons for women to consent, such as goodwill for science or personal benefits, or to decline, such as not wanting to be randomized or fear of increased risk of having a vacuum-assisted delivery. "Thoughts evoked regarding childbirth" were diverse, ranging from not being affected at all to having increased anxiety. Conclusions: The women's experience of receiving an invitation to participate in an RCT of episiotomy in vacuum-assisted delivery varied widely, from immediately giving consent without further worries to increased anxiety or declining participation. Early and personal information with time for reflection was considered most satisfactory.
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| 15. |
- Fuxe, Vendela, et al.
(författare)
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Delivery mode and severe maternal and neonatal morbidity among singleton term breech births : A population-based cohort study
- 2022
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Ingår i: European Journal of Obstetrics, Gynecology, and Reproductive Biology. - : Elsevier. - 0301-2115 .- 1872-7654. ; 272, s. 166-172
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The aim of this study was to examine the association between delivery mode and severe maternal and neonatal morbidity in singleton term breech births.& nbsp;Study design: This nationwide population-based cohort study includes 41 319 singleton term and post-term breech births (37 + 0-42 + 6 gestational weeks) in Sweden from 1998 to 2016. Data was retrieved from the Swedish Medical Birth Register. The primary outcomes were two separate composite outcomes, maternal and neonatal severe morbidity. Secondary outcomes were separate severe maternal and neonatal morbidity outcomes. Hospitalization and out-patient visits during childhood were also analyzed in ages 0-5 years. Logistic regression was used to estimate unadjusted and adjusted odds ratios (aOR) with 95% confidence intervals (CI) of severe maternal and neonatal morbidity in women with vaginal breech birth or intrapartum cesarean section. Women with a prelabor breech cesarean section was used as the reference group.& nbsp;Results: No difference between vaginal delivery and prelabor cesarean section was seen regarding maternal morbidity. Intrapartum cesarean section was associated with elevated odds for maternal morbidity (aOR 1.27, 95% CI 1.10-1.47) compared with prelabor cesarean section. A similar result was observed for vaginal delivery and intrapartum cesarean section combined (aOR 1.29, 95% CI 1.11-1.50). Vaginal delivery was associated with higher odds for composite neonatal morbidity (aOR 1.85, CI 1.54-2.21) and most separate outcomes, as well as increased number of hospital nights and out-patient visits during first year of life, compared with prelabor cesarean section.& nbsp;Conclusions: Prelabor cesarean section in breech births improved short-term neonatal health without increasing risks for severe maternal short-term complications.
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| 16. |
- Landtblom, Anna Ravn, et al.
(författare)
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Pregnancy and childbirth outcomes in women with myeloproliferative neoplasms-a nationwide population-based study of 342 pregnancies in Sweden
- 2022
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Ingår i: Leukemia. - : SPRINGER NATURE. - 0887-6924 .- 1476-5551. ; 36:10, s. 2461-2467
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Tidskriftsartikel (refereegranskat)abstract
- Pregnancy and childbirth in women with myeloproliferative neoplasms (MPN) are reported to be associated with maternal thrombosis, hemorrhage, and placental dysfunction. To assess the risks of adverse events in pregnancy in women with MPN, we performed a large population-based study using Swedish health care registers, and included all pregnancies that had reached gestational week 22 (prior to 2008, week 28) during the years 1973-2017 in women with MPN. Control pregnancies were matched 1:1 for age, calendar year, and parity. We identified 342 pregnancies in 229 women with MPN. Preterm birth was significantly increased in pregnancies in MPN, 14% compared to 4% of pregnancies in controls (p < 0.001). Correspondingly, low birth weight (<2500 g) was also significantly increased in MPN pregnancies (p = 0.042). Stillbirth was rare, with two events (0.6%) in MPN, none in controls. Maternal thrombotic complications occurred in three (1%) of the pregnancies in MPN patients, compared to none in controls. Pregnancy-related bleeding affected 14% of pregnancies in MPN and 9% in controls (p < 0.110). Cesarean section was significantly more common in pregnancies in MPN. Incidence was 12.2 per 100.000 pregnancies. In summary, preterm birth was an important complication in MPN pregnancies, while maternal complications were less common than previously reported.
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| 17. |
- Malm, Mari-Cristin, et al.
(författare)
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Episiotomy or not? : Midwives' experiences of recruiting to a randomized controlled trial during pregnancy and labor – A qualitative study
- 2021
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Ingår i: Sexual & Reproductive HealthCare. - : Elsevier. - 1877-5756 .- 1877-5764. ; 30
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The performance of randomized controlled trials (RCTs) is dependent on recruitment. Recruiting women to RCTs regarding interventions during childbirth may be difficult due to time constraints and their vulnerable situation. Midwives play a major role in such recruitment. Few studies have investigated the views and experiences of recruiters. The aim of this study was to describe midwives' experiences of recruiting pregnant women regarding an RCT of lateral episiotomy or no episiotomy in vacuum-assisted delivery.Methods: In this qualitative study, 19 midwives were interviewed regarding their experiences. The midwives worked at antenatal health care centers or labor wards. The transcribed interviews were analyzed using content analysis.Results: Four categories appeared during the analysis, including "experiences and perceptions of providing trial information" and "the right timing in providing trial information," which varied among the midwives. Midwives' perceptions of how the women provided consent or declined participation, and the women's views and questions about the randomization and intervention, were summarized as "experiences of how the trial information was received by the women." In the final category, "perceived trial apprehensions and concerns," some midwives described ethical concerns related to the intervention and financial compensation to the staff involved.Conclusions: Midwives as recruiters would benefit from education and training in incorporating basic and advanced details of trial design and research methods, as well as training and support in recruitment. Awareness and management of the variation among potential recruiters is important when designing and performing an RCT.
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| 18. |
- Mühlrad, Hanna, et al.
(författare)
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Interpregnancy interval and maternal and neonatal morbidity : a nationwide cohort study
- 2022
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Ingår i: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 12
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Tidskriftsartikel (refereegranskat)abstract
- This study aimed to assess the association between interpregnancy interval (IPI)—the time from childbirth to conception of the next pregnancy—and maternal and neonatal morbidity. The World Health Organization (WHO) currently recommends an IPI of at least 24 months after a live birth to reduce adverse birth outcomes. However, assessing the relationship between IPI and perinatal outcome is complicated by confounding factors. We conducted a nationwide population-based cohort study using Swedish registry data, allowing for adjustment of maternal characteristics and health at first birth. The study population consisted of all women with a singleton, live, and vaginal first birth with a second singleton birth within five years during 1997–2017, covering 327,912 women and 655,824 neonates. IPI was grouped into six-month intervals with 24–29 months as the reference. The association between IPI and morbidity was examined using multivariate logistic regression. For women having a vaginal delivery at their first birth, intervals < 24–29 months were associated with decreased maternal morbidity and unaffected neonatal morbidity. Intervals > 24–29 months were associated with increased maternal and neonatal morbidity. Our findings question the relevance of WHO’s recommendation of an IPI of at least 24 months in a high-income country.
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| 19. |
- Savchenko, Julia, et al.
(författare)
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Key outcomes in childbirth : Development of a perinatal core outcome set for management of labor and delivery at or near term
- 2023
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley-Blackwell. - 0001-6349 .- 1600-0412. ; 102:6, s. 728-734
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Consistency and relevance of perinatal outcome measures are necessary basics for obstetric research, audit, and clinical counseling. Still, there is an unwarranted variation in reported perinatal outcomes, which impairs research synthesis, validity, and implementation, as well as clinical benchmarking and longitudinal comparisons. The aim of this study was to develop a short-term perinatal (fetal and neonatal) Core Outcome Set to be used in research and quality assurance of management of labor and delivery at or near term.Material and methods: The methods were guided by the Core Outcome Measures in Effectiveness Trials Initiative Handbook. The project was prospectively registered on July 2, 2020 in the Core Outcome Measures in Effectiveness Trials (COMET) data base (reference number 1593). A list of potential outcomes was created based on a systematic review of studies evaluating interventions for peripartum management at or near term (>= 34 weeks of gestation), including decisions regarding timing and type of onset of labor, intrapartum care, and mode of delivery. The list was entered into a two-round Delphi survey with predefined consensus criteria. Participants (n = 67) included clinicians, researchers, lay persons with experience of childbirth (patient representatives), and other stakeholders. A consensus meeting was held to reach a final agreement.Results: Response rates were 82.1% (55/67) and 92.7% (51/55) for the first and second Delphi rounds, respectively. In total, 17 outcomes were included in the final core outcome set, reflecting mortality, health or morbidity, including asphyxia, central nervous system status, infection, neonatal resuscitation and admission, breastfeeding and mother-infant interaction, operative delivery due to fetal distress, as well as birthweight and gestational age. Two of these outcomes were suggested by patient representatives.Conclusions: The Swedish Perinatal Core Outcome Set (SPeCOS) study involved a broad circle of relevant stakeholders and reached consensus on a minimal set of perinatal outcomes that should be collected and reported in a standardized way in all future studies on management of labor and delivery at or near term, regardless of the specific population or condition studied. This could improve obstetric research, evidence synthesis, uptake, implementation, and adherence, as well as clinical practice, audit, and comparisons in childbirth care.
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| 20. |
- Wennerholm, Ulla-Britt, 1948, et al.
(författare)
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Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS) : multicentre, open label, randomised, superiority trial
- 2019
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Ingår i: The BMJ. - : BMJ Publishing Group Ltd. - 1756-1833 .- 0959-8138. ; 367
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks.DESIGN: Multicentre, open label, randomised controlled superiority trial.SETTING: 14 hospitals in Sweden, 2016-18.PARTICIPANTS: 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group.INTERVENTIONS: Induction of labour at 41 weeks and expectant management and induction of labour at 42 weeks.MAIN OUTCOME MEASURES: The primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat.RESULTS: The study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups.CONCLUSIONS: This study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths.TRIAL REGISTRATION: Current Controlled Trials ISRCTN26113652.
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| 21. |
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