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  1. Article ; Online: Pregnancy of unknown location

    Christina Bergh / Annika Strandell / Johan Fistouris

    BMJ Open, Vol 12, Iss

    external validation of the hCG-based M6NP and M4 prediction models in an emergency gynaecology unit

    2022  Volume 11

    Abstract: Objective To investigate if M6NP predicting ectopic pregnancy (EP) among women with pregnancy of unknown location (PUL) is valid in an emergency gynaecology setting and comparing it with its predecessor M4.Design Retrospective cohort study.Setting ... ...

    Abstract Objective To investigate if M6NP predicting ectopic pregnancy (EP) among women with pregnancy of unknown location (PUL) is valid in an emergency gynaecology setting and comparing it with its predecessor M4.Design Retrospective cohort study.Setting University Hospital.Participants Women with PUL.Methods All consecutive women with a PUL during a study period of 3 years were screened for inclusion. Risk prediction of an EP was based on two serum human chorionic gonadotropin (hCG) levels taken at least 24 hours and no longer than 72 hours apart.Main outcome measures The area under the ROC curve (AUC) expressed the ability of a model to distinguish an EP from a non-EP (discrimination). Calibration assessed the agreement between the predicted risk of an EP and the true risk (proportion) of EP. The proportion of EPs and non-EPs classified as high risk assessed the model’s sensitivity and false positive rate (FPR). The proportion of non-EPs among women classified as low risk was the model’s negative predictive value (NPV). The clinical utility of a model was evaluated with decision curve analysis.Results 1061 women were included in the study, of which 238 (22%) had a final diagnosis of EP. The AUC for EP was 0.85 for M6NP and 0.81 for M4. M6NP made accurate risk predictions of EP up to predictions of 20% but thereafter risks were underestimated. M4 was poorly calibrated up to risk predictions of 40%. With a 5% threshold for high risk classification the sensitivity for EP was 95% for M6NP, the FPR 50% and NPV 97%. M6NP had higher sensitivity and NPV than M4 but also a higher FPR. M6NP had utility at all thresholds as opposed to M4 that had no utility at thresholds≤5%.Conclusions M6NP had better predictive performance than M4 and is valid in women with PUL attending an emergency gynaecology unit. Our results can encourage implementation of M6NP in related yet untested clinical settings to effectively support clinical decision-making.
    Keywords Medicine ; R
    Subject code 610
    Language English
    Publishing date 2022-11-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: HOPPSA update

    Annika Idahl / Per Liv / Anna Darelius / Elin Collins / Karin Sundfeldt / Mathias Pålsson / Annika Strandell

    Trials, Vol 24, Iss 1, Pp 1-

    changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial

    2023  Volume 5

    Abstract: Abstract Background The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC) ...

    Abstract Abstract Background The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC). The study protocol was first published in January 2019 and is available at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3083-8 . Here, we report amendments made to the study protocol since commencement of the trial. Changes in methods and analysis The primary outcomes analyses have been changed. (1) Complications will be analyzed using binomial generalized estimating equation (GEE) with log link function, while the unadjusted analyses according to Miettinen and Nurminen will be performed as a sensitivity analysis. (2) Absolute change in Menopause Rating Scale (MRS) will primarily be analyzed using a mixed effects model, adjusted for baseline MRS and center as a random effect. (3) Time to EOC will be analyzed using the mixed effects Cox regression model with center as random effect, while the unadjusted log-rank test will be performed as a sensitivity analysis. The primary outcome Complications will be based solely on the specific assessment in the GynOp quality registry. The Clavien-Dindo classification will be evaluated as a secondary outcome. Furthermore, MRS is also measured three years postoperatively to better pinpoint the onset of menopausal symptoms. Discussion The changes to the protocol mainly concern the analyses of data. No changes to recruitment, randomization, intervention, or follow-up of primary outcomes have been made. An interim analysis during 2021 concluded that the study should continue until the target sample size is reached. Trial registration ClinicalTrials.gov, NCT03045965 . Registered 8 February 2017.
    Keywords HOPPSA ; Opportunistic salpingectomy ; Hysterectomy ; Complications ; Menopausal symptoms ; Ovarian cancer ; Medicine (General) ; R5-920
    Subject code 310
    Language English
    Publishing date 2023-03-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: SALpingectomy for STERilisation (SALSTER)

    Per Liv / Annika Strandell / Karin Sundfeldt / Annika Idahl / Leonidas Magarakis / Mathias Pålsson

    BMJ Open, Vol 13, Iss

    study protocol for a Swedish multicentre register-based randomised controlled trial

    2023  Volume 9

    Abstract: Introduction Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the ... ...

    Abstract Introduction Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the existing trials on safety are small, on caesarean section and report on surrogate ovarian function measures. Randomised trials in laparoscopy are lacking. Well-designed trials are needed to evaluate safety of laparoscopic opportunistic salpingectomy.Methods and analysis In SALSTER, a national register-based randomised controlled non-inferiority trial, 968 women <50 years, wishing laparoscopic sterilisation will be randomised to either salpingectomy or tubal ligation. The Swedish National Quality Register of Gynecological Surgery (GynOp) will be used for inclusion, randomisation and follow-up. Primary outcomes are any complication up to 8 weeks postoperatively, and age at menopause. Both outcomes are measured with questionnaires, complications are also assessed by a gynaecologist. In a nested trial, ovarian function will be evaluated comparing the mean difference of anti-Müllerian hormone (AMH), assessed preoperatively and 1 year after surgery.Ethics and dissemination Performing salpingectomy for sterilisation has become increasingly common, despite the unclear risk-benefit balance. SALSTER studies the safety of salpingectomy compared with tubal ligation. Regardless of the result, SALSTER will provide gynaecologists with high quality evidence to inform women to decide on salpingectomy or not. The central ethical review board of Gothenburg, Sweden (Dnr. 316–18) approved the trial in 2018. Results will be presented at scientific congresses and published in peer-reviewed scientific journals. The results will be communicated through professional organisations and research networks.Trial registration number NCT03860805.
    Keywords Medicine ; R
    Subject code 170
    Language English
    Publishing date 2023-09-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Hysterectomy and opportunistic salpingectomy (HOPPSA)

    Annika Idahl / Anna Darelius / Karin Sundfeldt / Mathias Pålsson / Annika Strandell

    Trials, Vol 20, Iss 1, Pp 1-

    study protocol for a register-based randomized controlled trial

    2019  Volume 10

    Abstract: Abstract Background There is a great need for a prospective randomized trial to evaluate the risks and benefits of opportunistic salpingectomy. Recently, genetic and morphologic studies have indicated that epithelial ovarian cancer predominantly develops ...

    Abstract Abstract Background There is a great need for a prospective randomized trial to evaluate the risks and benefits of opportunistic salpingectomy. Recently, genetic and morphologic studies have indicated that epithelial ovarian cancer predominantly develops in the Fallopian tubes. Consequently, there is reason to believe that salpingectomy would reduce the risk of ovarian cancer. Studies on reducing the risk of ovarian cancer have compared indicated salpingectomy with no salpingectomy, while studies on surgical safety as well as ovarian function after opportunistic salpingectomy have been small with a short follow-up. No study has reported menopausal symptoms. Methods/design In this national register-based randomized controlled trial, women <55 years old, planned for a hysterectomy for a benign cause, will be randomized to concomitant salpingectomy or no salpingectomy. The follow-up will be conducted according to already established routines within the register using on-line questionnaires. Primary outcomes have been defined for three different time points: short-term complications up to 8 weeks postoperatively (n = 2800), intermediate-term changes in menopausal symptoms measured by the Menopause Rating Scale at baseline and after 1 year (n = 1670), and long-term epithelial ovarian cancer assessed through national registers after 30 years (n = 5052) (or n = 7001 for high-grade serous cancer). In a sub-study of 75 women, ovarian function will be evaluated through change in anti-Müllerian hormone measured before surgery and after 1 year. Discussion Hysterectomy for a benign cause is a common surgical procedure and several national societies recommend salpingectomy while performing a benign hysterectomy, despite a lack of scientific evidence for the safety of the procedure. Sweden has unique conditions for clinical trials because of its national quality registers and health registers with excellent quality and near complete coverage. If no additional risks are associated with concomitant salpingectomy, it can be ...
    Keywords Ovarian cancer ; Opportunistic salpingectomy ; Early menopause ; Hysterectomy ; Complications ; Menopausal symptoms ; Medicine (General) ; R5-920
    Subject code 616
    Language English
    Publishing date 2019-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Progesterone, cerclage, pessary, or acetylsalicylic acid for prevention of preterm birth in singleton and multifetal pregnancies – A systematic review and meta-analyses

    Ulla-Britt Wennerholm / Lina Bergman / Pihla Kuusela / Elin Ljungström / Anna C. Möller / Cecilie Hongslo Vala / Ann-Catrin Ekelund / Ann Liljegren / Max Petzold / Petteri Sjögren / Mikael Svensson / Annika Strandell / Bo Jacobsson

    Frontiers in Medicine, Vol

    2023  Volume 10

    Abstract: BackgroundPreterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on progesterone, cerclage, pessary, and acetylsalicylic acid (ASA) to prevent ... ...

    Abstract BackgroundPreterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on progesterone, cerclage, pessary, and acetylsalicylic acid (ASA) to prevent preterm birth in asymptomatic women with singleton pregnancies defined as risk of preterm birth and multifetal pregnancies.MethodsSix databases (including PubMed, Embase, Medline, the Cochrane Library) were searched up to February 2022. RCTs published in English or Scandinavian languages were included through a consensus process. Abstracts and duplicates were excluded. The trials were critically appraised by pairs of reviewers. The Cochrane risk-of-bias tool was used for risk of bias assessment. Predefined outcomes including preterm birth, perinatal/neonatal/maternal mortality and morbidity, were pooled in meta-analyses using RevMan 5.4, stratified for high and low risk of bias trials. The certainty of evidence was assessed using the GRADE approach. The systematic review followed the PRISMA guideline.ResultsThe search identified 2,309 articles, of which 87 were included in the assessment: 71 original RCTs and 16 secondary publications with 23,886 women and 32,893 offspring. Conclusions were based solely on trials with low risk of bias (n = 50).Singleton pregnancies: Progesterone compared with placebo, reduced the risk of preterm birth <37 gestational weeks: 26.8% vs. 30.2% (Risk Ratio [RR] 0.82 [95% Confidence Interval [CI] 0.71 to 0.95]) (high certainty of evidence, 14 trials) thereby reducing neonatal mortality and respiratory distress syndrome. Cerclage probably reduced the risk of preterm birth <37 gestational weeks: 29.0% vs. 37.6% (RR 0.78 [95% CI 0.69 to 0.88]) (moderate certainty of evidence, four open trials). In addition, perinatal mortality may be reduced by cerclage. Pessary did not demonstrate any overall effect. ASA did not affect any outcome, but evidence was based on one underpowered study.Multifetal pregnancies: The effect of progesterone, ...
    Keywords preterm birth ; perinatal morbidity and mortality ; progesterone ; cerclage ; pessary ; acetylsalicylic acid ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2023-02-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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