| 1. |
- André, Kristin, et al.
(författare)
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Minimizing tearing during vaginal delivery with a perineal protection device : a randomized controlled trial
- 2024
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Ingår i: American Journal of Obstetrics & Gynecology MFM. - 2589-9333.
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThere is a growing body of evidence indicating that second degree tears cause both short-, and long-term consequences. Very few preventative measures have been found to reduce the incidence of these tears.ObjectiveTo investigate if the use of a perineal protection device during vaginal birth reduces severe perineal tearing (≥grade 2 tear) in primiparous women compared to routine manual perineal support.Study designA single center randomized controlled trial was performed in Sweden 2019-2021. Primiparous women at term were randomly allocated to the intervention group (n=43) where a perineal protection device was used, or to receive routine care (n=49). Main outcome measurement was grade of perineal tear. Secondary outcomes were vaginal and labial tearing. Continuous data was analyzed with Student's T-test or Mann-Whitney U-test. Dichotomous data were analyzed with Pearson X2 test, Fisher's Exact test, and ordinal logistic regression.ResultsWomen in the intervention group had a significantly lower risk of sustaining more extensive perineal tearing as compared to the control group. Use of the perineal protection device decreased risk of ≥grade 2 tears, in relation to grade 0-1 tears (OR 0.40 [95% CI 0.17–0.94]). Ordinal logistic regression analyses revealed an OR of 0.36 (0.16–0.81) for one-grade-injury increment, using the perineal protection device vs control group (p=0.013). Number needed to treat using the perineal protection device was 4.3 to avoid one ≥grade 2 tear. Women in the treatment group had less labial tearing (p=0.016). No adverse effects were detected.ConclusionsUse of the perineal protection device reduced the risk of perineal tearing ≥grade 2 tear by 60% as well as labial tearing.
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| 2. |
- 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 (Clinical research ed.). - : BMJ Publishing Group Ltd. - 1756-1833. ; 385
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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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| 3. |
- 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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| 4. |
- Jacobsson, Bo, 1960, et al.
(författare)
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Preterm delivery: an overview on prediction, prevention and treatment : Prediktion, prevention och behandlingsmetoder.
- 2019
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Ingår i: Läkartidningen. - 1652-7518. ; 116
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Tidskriftsartikel (refereegranskat)abstract
- Due to a low level of understanding of mechanisms involved in spontaneous preterm delivery there is a lack of reliable biomarkers. Existing biomarkers have a low positive predictive value but a high negative predictive value. Use of tests with high negative predictive value will reduce unnecessary interventions and hospitalization of women with threatening preterm delivery. When given to the right pregnant women, antenatal corticosteroid treatment are still the most important obstetrical intervention and reduces both neonatal mortality and short- and long-term morbidity.Several ongoing national Swedish multicenter studies may increase the understanding of the roles of cervical length, preeclampsia screening and magnesium sulfate dosage in the context of preterm delivery in a Nordic setting. Major development has been achieved in prediction and prevention of preterm preeclampsia at the cost of a 10% screen positive rate.
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| 5. |
- Leijonhufvud, Åsa
(författare)
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Pelvic floor dysfunction depending on mode of delivery : clinical and epidemiological aspects
- 2012
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Objective: To study pelvic floor disorders in relation to mode of delivery using clinical and epidemiological methods; to compare the prevalence and risk of lower urinary tract symptoms (LUTS) in healthy primiparous women in relation to vaginal (VD) or elective cesarean (CD) delivery nine months after delivery; to estimate the effect of delivery on urinary and anal incontinence 10 years after first childbirth in relation to mode of delivery and to assess the influence of parity and obstetrical events; to estimate the risks of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) surgery related to delivery mode at long-term follow-up; and to evaluate the influence of age at first childbirth on the risks of surgically managed SUI and POP. Methods: Paper I is a clinical study of 435 subjects, with prospectively collected data based on self-reported questionnaires and medical charts. Paper II is a cross-sectional comparative study of 395 subjects, and Paper III and IV are nationwide cohort studies including over 90,000 subjects, based on data from the Swedish Medical Birth Register and the Swedish Inpatient Register. Statistical analysis was performed on the clinical cohorts, fulfilling a power criteria of α<0.05, β=0.8, using non-parametric statistics, correlation coefficients and logistic regression. Incidence rates, Hazard Ratios (HR) and NNH were calculated on the population-based cohorts. Results: VD was associated with a significantly increased prevalence and risk of LUTS nine months after childbirth when compared to elective CD (RRSUI 8.9 95%CI 1.9-42). De Novo SUI was likewise more prevalent after VD. The protective effect of CD was absent in subjects reporting SUI before pregnancy, symptoms before pregnancy or at three months follow-up (RRSUI 3.9 95%CI 1.7-8.5) were independent risk factors for persistent symptoms at nine months follow-up, with a higher prevalence of SUI after VD. At 10 years follow-up were urinary and anal incontinence symptoms significantly more common following spontaneous VD. Women with an obstetrical history of anal sphincter injury carried a substantially increased risk of gas incontinence (OR 3.1 95%CI 1.5-8.9). However, CD is not associated with a major reduction of urinary incontinence symptoms and an association between delivery mode and anal incontinence could not be confirmed. A significantly increased risk of SUI and POP surgery later in life was seen in women with only VD compared to only having had CD (HRSUI 2.9 95%CI 2.4-3.6, HRPOP 9.2 95%CI 7.0-12.1). The increased risk of surgically managed pelvic floor disorders persisted for the three decades of follow-up and was especially pronounced in multiparous women. An age dependent effect was seen with higher age at first delivery associated with higher risk and incidence rate of subsequent pelvic floor surgery in both delivery groups. The protective effect of CD remained in all age categories, predominantly for POP in women ≥ 30 years of age at first childbirth. Conclusions: The studies in this thesis provides clinical and epidemiological evidence that obstetrical intervention at the time of childbirth may to some extent prevent SUI and POP later in life, particularly in multiparous women and women over 30 years of age at first delivery. However, the protective effects of CD with regard to pelvic floor disorders must be weighed against postpartum maternal and neonatal morbidity associated with the procedure.
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| 6. |
- Tsatsanis, Christos, et al.
(författare)
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Sex hormone-dependent and-independent regulation of serum BAFF and TNF in cohorts of transgender and cisgender men and women
- 2023
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Ingår i: Endocrine Connections. - 2049-3614. ; 12:3
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Tidskriftsartikel (refereegranskat)abstract
- Background: The risk of inflammatory diseases is sex-dependent, but it remains unknown whether this is due to the impact of sex hormones or sex chromosomes. Transgender individuals represent a unique cohort for studying the relative influence of endocrine and chromosomal factors. Here we compared serum levels of B-cell activating-factor (BAFF) and tumor necrosis factor (TNF) in transgender men (TM), transgender women (TW), cisgender women (CW) and cisgender men (CM). Methods: BAFF and TNF were measured in the serum of 26 CW, 30 CM, 27 TM and 16 TW individuals. To determine the responsiveness of immune cells, TNF was measured in bacterial lipopolysaccharide (LPS)-treated peripheral leukocytes. Results: BAFF was higher in CF (998 pg/mL) and TW (973 pg/mL) compared to CM (551 pg/mL) (P < 0.0001) and TM (726 pg/mL) (P < 0.0001). No difference in BAFF levels was shown between subjects grouped according to the number of X chromosomes. TNF was higher in CM (174 pg/mL) than TW (2.3 pg/mL) (P = 0.027) and TM (27.4 pg/mL) (P = 0.028). LPS-induced TNF was higher in CM (2524 pg/mL) and TM (2078 pg/mL) than in CW (1332 pg/mL) (both P < 0.0001) and TW (1602 pg/mL) (both P = 0.009). Discussion: Sex hormones and sex chromosomes have different impacts on cytokines involved in the sex-dependent inflammatory response. The concentration of BAFF and LPS-stimulated TNF secretion depended on sex hormone levels, whereas basal TNF was regulated by both sex hormone-dependent and-independent factors.
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