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  • 1. Järnbert-Pettersson, Hans
    et al.
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    Labour pain - poorly analysed and reported: a systematic review2018In: BMC Pregnancy and Childbirth, ISSN 1471-2393, E-ISSN 1471-2393, Vol. 18, no 1, article id 483Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Modelling and analysing repeated measures data, such as women's experiences of pain during labour, is a complex topic. Traditional end-point analyses such as t-tests, ANOVA, or repeated measures [rANOVA] have known disadvantages. Modern and more sophisticated statistical methods such as mixed effect models provide flexibility and are more likely to draw correct conclusions from data. The aim of this study is to study how labour pain is analysed in repeated measures design studies, and to increase awareness of when and why modern statistical methods are suitable with the aim of encouraging their use in preference of traditional methods.

    METHODS: Six databases were searched with the English language as a restriction. Study eligibility criteria included: Original studies published between 1999 and 2016, studying pregnant women in labour with the aim to compare at least two methods for labour pain management, with at least two measurements of labour pain separated by time, and where labour pain was analysed. After deduplication, all records (n = 2800) were screened by one of the authors who excluded ineligible publication types, leaving 737 records remaining for full-text screening. A sample of 309 studies was then randomly selected and screened by both authors.

    RESULTS: Among the 133 (of 309) studies that fulfilled the study eligibility criteria, 7% used mixed effect models, 20% rANOVA, and 73% used end-point analysis to draw conclusions regarding treatment effects for labour pain between groups. The most commonly used end-point analyses to compare groups regarding labour pain were t-tests (57, 43%) and ANOVA (41, 31%). We present a checklist for clinicians to clarify when mixed effect models should be considered as the preferred choice for analysis, in particular when labour pain is measured.

    CONCLUSIONS: Studies that aim to compare methods for labour pain management often use inappropriate statistical methods, and inaccurately report how the statistical analyses were carried out. The statistical methods used in analyses are often based on assumptions that are not fulfilled or described. We recommend that authors, reviewers, and editors pay greater attention to the analysis when designing and publishing studies evaluating methods for pain relief during labour.

  • 2.
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Karolinska institutet.
    Acupuncture for labour pain2015Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Background: Acupuncture involves puncturing the skin with thin sterile needles at defined acupuncture points. Previous studies are inconclusive regarding the effect of acupuncture on labour pain, but some studies have found a reduction in the use of pharmacological pain relief when acupuncture is administered. The appropriate dose of acupuncture treatment required to elicit a potential effect on labour pain has not been fully explored. The dose is determined by many different factors, including the number of needles used and the intensity of the stimulation. In Sweden, manual stimulation of the needles is common practice when acupuncture is used for labour pain, but electrical stimulation of the needles, which gives a higher dose, could possibly be more effective. The overall aim of this thesis was to evaluate the effectiveness of acupuncture with manual stimulation (MA) of the needles as well as acupuncture with a combination of manual and electrical stimulation (EA) in reducing labour pain, compared with standard care without any form of acupuncture (SC).

    Methods: The study was designed as a three-armed randomised controlled trial in which 303 nulliparous women with normal pregnancies were randomised to MA, EA, or SC. The primary outcome was labour pain, assessed using the Visual Analogue Scale (VAS). Secondary outcomes were relaxation during labour, use of obstetric pain relief, and associations between maternal characteristics and labour pain and use of epidural analgesia respectively. Also, labour and infant outcomes, recollection of labour pain, and maternal experiences, such as birth experience and experience of the midwife, were investigated two months after the birth. The sample size calculation was based on the potential to discover a difference of 15 mm on the VAS. Data were collected during labour before the interventions, the day after birth, and two months later. Besides using the VAS, information was collected by means of study specific protocol, questionnaires and medical records.

    Results: The mean VAS scores were 66.4 in the MA group, 68.5 in the EA group, and 69.0 in the SC group (mean differences: MA vs. SC 2.6 95% CI -1.7 to 6.9, and EA vs. SC 0.6 95% CI -3.6 to 4.8). Other methods of pain relief were used less frequently in the EA group, including epidural analgesia, MA 61.4%, EA 46%, and SC 69.9%. (EA vs. SC OR 0.4 95% CI 0.2 to 0.7). No statistically significant differences were found in the recollection of labour pain between the three groups two months after birth (mean VAS score: MA 69.3, EA 68.7 and SC 70.1). A few maternal characteristics were associated with labour pain (age, dysmenorrhea, and cervix dilatation), but none of the investigated characteristics predicted the outcome of the acupuncture treatment in MA or EA. Women in the EA group experienced acupuncture as being effective for labour pain to a higher extent than women who received MA, MA 44.4%, EA 67.1% (EA vs. MA OR 2.4 95% CI 1.2 to 4.8). Women in the EA group also spent less time in labour (mean 500 min) than those who received MA (mean 619 min) and SC (mean 615 min) (EA vs. MA HR 1.4 95% CI 1.0 to1.9, EA vs. SC HR 1.4, 95% CI 1.1 to 2.0), and had less blood loss than women receiving SC, (EA vs. SC OR 0.1 95% CI 0.3 to 0.7). The women’s assessment of the midwife as being supportive during labour (MA 77.2%, EA 83.5%, SC 80%), overall satisfaction with midwife care (MA 100%, EA 97.5%, SC 98.7%), and having an overall positive childbirth experience (MA 64.6%, EA 61.0%, SC 54.3%) did not differ statistically. No serious side effects of the acupuncture treatment were reported.

    Conclusion: Acupuncture, regardless of type of stimulation, did not differ from standard care without acupuncture in terms of reducing women’s experience of pain during labour, or their memory of pain and childbirth overall two months after the birth. However, other forms of obstetric pain relief were less frequent in women receiving a combination of manual and electrical stimulation, suggesting that this method could facilitate coping with labour pain.

  • 3.
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    Acupuncture for Labour Pain2015Conference paper (Other academic)
  • 4.
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    Acupuncture with manual and electrical stimulation for labour pain: A longitudinal randomised controlled trial2014Conference paper (Other academic)
    Abstract [en]

    Background Acupuncture using manual stimulation (MA) of the needles is commonly used to reduce labour pain despite contradictory results from studies of its effectiveness. A combination of manual and electrical stimulation (EA) could reduce labour pain more effectively than MA alone, by a higher treatment intensity.The aim was to evaluate the effectiveness of MA and EA compared with standard care without any acupuncture (SC) in reducing labour pain. Our hypothesis was that both acupuncture stimulation techniques were more effective than SC, and that EA was the most effective.

    Methods

    Nulliparous women (n=303) with a normal pregnancy were equally randomized to three groups receiving 40 minutes of either MA, EA or to SC. The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals.

    The primary outcome was women’s assessment of labour pain; before and after the first treatment, every 30 minutes for five hours, and thereafter every hour until birth, or until epidural analgesia was administered. For the primary outcome, a linear mixed model for repeated measures was performed to investigate associations between treatment (MA, EA, SC) and pain scores on VAS over time. A difference of 15 mm on the visual analogue scale (VAS) was regarded as clinically relevant, and this required 41 women per group, and compensating for dropouts, in total 101 women in each group.

    Data on the primary outcome were obtained from 253 women: MA n=83, EA n=87, and SC n=83.

    Results

    Primary outcome:

    Mean estimated pain scores on VAS (SC: 69.0, MA: 66.4 and EA: 68.5), adjusted for: treatment, age, education, and time from baseline, with no interactions did not differ between the groups (SC vs MA: mean difference 2.6, 95 % confidence interval [CI] -1.7-6.9 and SC vs EA: mean difference 0.6 [95%CI] -3.6-4.8).

    Secondary outcomes:

    Use of epidural analgesia: MA 61%, EA 46%, SC 70%. EA vs SC: odds ratio (OR) 0.35; (95% CI) 0.19-0.67.

    EA vs MA: OR 0.57 (95% CI) 0.31-1.06.

    Duration of labour (min): MA 619, EA 500, SC 615. EA vs SC: Hazard Ratio (HR) 1.44; (95% CI) 1.06-1.97. EA vs MA: HR 1.41; (95% CI) 1.03-1.91.

    Sufficient pain relief (day after partus): MA 77%, EA 81%, SC 74% (ns).

    Positive experience of the midwife (day after partus): MA 100%, EA 97.5%, and SC 98.7% (ns).

    Support from the midwife to a high extent (day after partus): MA 77.2%, EA 83.5%, and SC 80% (ns).

    Conclusions

    Acupuncture does not reduce women’s experience of labour pain, however, women receiving a combination of manual and electro-acupuncture (EA) used less additional pain relief, including epidural analgesia, and had shorter labour than women in the standard care group (SC). Despite the lower use of other pain relief, a majority of the women who used EA were equally satisfied with their pain relief as the women receiving manual acupuncture alone (MA) or SC. They were also equally satisfied with the support from the midwife.

     

  • 5.
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Karolinska institutet.
    Acupuncture with manual and electrical stimulation for labour pain: A longitudinal randomised controlled trial2014Conference paper (Other academic)
  • 6.
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    Associations between maternal characteristics and women’s responses to acupuncture during labour: a secondary analysis from a randomised controlled trial2017In: Acupuncture in Medicine, ISSN 0964-5284, E-ISSN 1759-9873, Vol. 35, no 3, p. 180-188Article in journal (Refereed)
    Abstract [en]

    Background Patient characteristics are modulators of pain experience after acupuncture treatment for chronic pain. Whether this also applies to labour pain is unknown.

    Aim To examine for associations between maternal characteristics and response to acupuncture in terms of labour pain intensity in close proximity to the treatment (within 60 min) and over a longer time period (up to 240 min), and whether or not epidural analgesia is used, before and after adjustment for obstetric status upon admission to the labour ward.

    Methods Cohort study (n=253) using data collected for a randomised controlled trial. Associations were examined using linear mixed models and logistic regression analyses. Tests of interactions were also applied to investigate whether maternal characteristics were influenced by treatment group allocation.

    Results In close proximity to the treatment, advanced age and cervical dilation were associated with lower pain scores (mean difference (MD) −13.2, 95% CI −23.4 to −2.9; and MD −5.0, 95% CI −9.6 to −0.5, respectively). For the longer time period, labour pain was negatively associated with age (MD −11.8, 95% CI −19.6 to −3.9) and positively associated with dysmenorrhoea (MD 5.5, 95% CI 1.6 to 9.5). Previous acupuncture experience and advanced cervical dilatation were associated with higher and lower use of epidural analgesia (OR 2.7, 95% CI 1.3 to 5.9; and OR 0.3, 95% CI 0.1 to 0.5, respectively). No interactions with treatment allocation were found.

    Conclusions This study did not identify any maternal characteristics associated with women's responses to acupuncture during labour.

    Trial registration number NCT01197950; Post-results.

  • 7.
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Karolinska Institutet.
    Manual and electroacupuncture for labour pain. Study design of a longitudinal randomized controlled trial2013Conference paper (Other academic)
    Abstract [en]

    Introduction: Results from previous acupuncture studies for labour pain are contradictory and lack important information on methodology. The sample sizes are in general small, information about the intervention such as needle placement, number of acupuncture points, type of stimulation, and duration of treatment, is often sparse or lacking However, studies indicate that acupuncture has a positive effect on women’s experiences of labour pain.

     

    Aim: The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain. Our hypothesis is that acupuncture with manual or electrical stimulation is more effective than standard care in the relief of labor pain, and that acupuncture with electrical stimulation is the most effective.

    Outcome measures: Primary outcome: Labour pain measured with visual analogue scale (VAS). Secondary outcomes are use of epidural analgesia, experience of relaxation, labour outcomes and infant outcomes. Biochemical markers of proinflammatory cytokines, memory of labour pain and overall childbirth experience.

    Methods: The study was designed as a randomized controlled trial based on Western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. VAS was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment.

    At the conference, information on the design of the study will be presented and the considerations of whether to use placebo controls or not will be discussed.

    ClinicalTrials.gov: NCT01197950

  • 8.
    Vixner, Linda
    et al.
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Karolinska institutet.
    Mårtensson, Lena B
    Schytt, Erica
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Acupuncture with manual and electrical stimulation for labour pain: a two month follow up of recollection of pain and birth experience.2015In: BMC Complementary and Alternative Medicine, ISSN 1472-6882, E-ISSN 1472-6882, Vol. 15, article id 180Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: In a previous randomised controlled trial we showed that acupuncture with a combination of manual- and electrical stimulation (EA) did not affect the level of pain, as compared with acupuncture with manual stimulation (MA) and standard care (SC), but reduced the need for other forms of pain relief, including epidural analgesia. To dismiss an under-treatment of pain in the trial, we did a long-term follow up on the recollection of labour pain and the birth experience comparing acupuncture with manual stimulation, acupuncture with combined electrical and manual stimulation with standard care. Our hypothesis was that despite the lower frequency of use of other pain relief, women who had received EA would make similar retrospective assessments of labour pain and the birth experience 2 months after birth as women who received standard care (SC) or acupuncture with manual stimulation (MA).

    METHODS: Secondary analyses of data collected for a randomised controlled trial conducted at two delivery wards in Sweden. A total of 303 nulliparous women with normal pregnancies were randomised to: 40 min of MA or EA, or SC without acupuncture. Questionnaires were administered the day after partus and 2 months later.

    RESULTS: Two months postpartum, the mean recalled pain on the visual analogue scale (SC: 70.1, MA: 69.3 and EA: 68.7) did not differ between the groups (SC vs MA: adjusted mean difference 0.8, 95 % confidence interval [CI] -6.3 to 7.9 and SC vs EA: mean difference 1.3 CI 95 % -5.5 to 8.1). Positive birth experience (SC: 54.3 %, MA: 64.6 % and EA: 61.0 %) did not differ between the groups (SC vs MA: adjusted Odds Ratio [OR] 1.8, CI 95 % 0.9 to 3.7 and SC vs EA: OR 1.4 CI 95 % 0.7 to 2.6).

    CONCLUSIONS: Despite the lower use of other pain relief, women who received acupuncture with the combination of manual and electrical stimulation during labour made the same retrospective assessments of labour pain and birth experience 2 months postpartum as those who received acupuncture with manual stimulation or standard care.

    TRIAL REGISTRATION: ClinicalTrials.gov: NCT01197950.

  • 9.
    Vixner, Linda
    et al.
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    Mårtensson, Lena B
    Stener-Victorin, Elisabet
    Schytt, Erica
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Division of Reproductive Health, Department of Women's and Children's Health, Karolinska Institutet.
    Manual and electroacupuncture for labour pain: study design of a longitudinal randomized controlled trial2012In: Evidence-based Complementary and Alternative Medicine, ISSN 1741-427X, E-ISSN 1741-4288, article id 943198Article in journal (Refereed)
    Abstract [en]

    Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women's experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.

  • 10.
    Vixner, Linda
    et al.
    Dalarna University, School of Education, Health and Social Studies, Medical Science. Department of Women’s and Children’s Health, Division of Reproductive Health, Karolinska Institutet, Retzius väg 13A, 171 77 Stockholm, Sweden.
    Schytt, Erica
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Centre for Clinical Research Dalarna, Nissers väg 3, 791 82 Falun, Sweden.
    Stener-Victorin, Elisabet
    Department of Physiology, Sahlgrenska Academy, Institute of Neuroscience and Physiology, University of Gothenburg, 405 30 Gothenburg, Sweden.
    Waldenström, Ulla
    Department of Women’s and Children’s Health, Division of Reproductive Health, Karolinska Institutet, Retzius väg 13A, 171 77 Stockholm, Sweden.
    Pettersson, Hans
    Department of Clinical Science and Education, Södersjukhuset Karolinska Institutet, Stockholm, Sweden.
    Mårtensson, Lena B.
    School of Health and Education, University of Skövde, P.O. Box 408, 541 28 Skövde, Sweden.
    Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial2014In: BMC Complementary and Alternative Medicine, ISSN 1472-6882, E-ISSN 1472-6882, Vol. 14, article id 187Article in journal (Refereed)
    Abstract [en]

    Background: Acupuncture is commonly used to reduce pain during labour despite contradictory results. The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation (electro-acupuncture) compared with standard care in reducing labour pain. Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care, and that electro-acupuncture was most effective. 

    Methods: A longitudinal randomised controlled trial. The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals. 303 nulliparous women with normal pregnancies were randomised to: 40 minutes of manual acupuncture (MA), electro-acupuncture (EA), or standard care without acupuncture (SC). Primary outcome: labour pain, assessed by Visual Analogue Scale (VAS). Secondary outcomes: relaxation, use of obstetric pain relief during labour and post-partum assessments of labour pain. The sample size calculation was based on the primary outcome and a difference of 15 mm on VAS was regarded as clinically relevant, this gave 101 in each group, including a total of 303 women. 

    Results: Mean estimated pain scores on VAS (SC: 69.0, MA: 66.4 and EA: 68.5), adjusted for: treatment, age, education, and time from baseline, with no interactions did not differ between the groups (SC vs MA: mean difference 2.6, 95% confidence interval [CI] -1.7-6.9 and SC vs EA: mean difference 0.6 [95% CI] -3.6-4.8). Fewer number of women in the EA group used epidural analgesia (46%) than women in the MA group (61%) and SC group (70%) (EA vs SC: odds ratio [OR] 0.35; [95% CI] 0.19-0.67). 

    Conclusions: Acupuncture does not reduce women's experience of labour pain, neither with manual stimulation nor with combined manual and electrical stimulation. However, fewer women in the EA group used epidural analgesia thus indicating that the effect of acupuncture with electrical stimulation may be underestimated. These findings were obtained in a context with free access to other forms of pain relief.

  • 11. Waldenström, U
    et al.
    Cnattingius, S
    Vixner, Linda
    Dalarna University, School of Education, Health and Social Studies, Medical Science.
    Norman, M
    Advanced maternal age increases the risk of very preterm birth, irrespective of parity: a population-based register study2017In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 124, no 8, p. 1235-1244Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To investigate whether advanced maternal age is associated with preterm birth, irrespective of parity.

    DESIGN: Population-based registry study.

    SETTING: Swedish Medical Birth Register.

    POPULATION: First, second, and third live singleton births to women aged 20 years or older in Sweden, from 1990 to 2011 (n = 2 009 068).

    METHODS: Logistic regression analysis was used in each parity group to estimate risks of very and moderately preterm births to women at 20-24, 25-29, 30-34, 35-39, and 40 years or older, using 25-29 years as the reference group. Odds ratios (ORs) were adjusted for year of birth, education, country of birth, smoking, body mass index, and history of preterm birth. Age-related risks of spontaneous and medically indicated preterm births were also investigated.

    MAIN OUTCOME MEASURES: Very preterm (22-31 weeks of gestation) and moderately preterm (32-36 weeks) births.

    RESULTS: Risks of very preterm birth increased with maternal age, irrespective of parity: adjusted ORs in first, second, and third births ranged from 1.18 to 1.28 at 30-34 years, from 1.59 to 1.70 at 35-39 years, and from 1.97 to 2.40 at ≥40 years. In moderately preterm births, age-related associations were weaker, but were statistically significant from 35-39 years in all parity groups. Advanced maternal age increased the risks of both spontaneous and medically indicated preterm births.

    CONCLUSIONS: Advanced maternal age is associated with an increased risk of preterm birth, irrespective of parity, especially very preterm birth. Women aged 35 years and older, expecting their first, second, or third births, should be regarded as a risk group for very preterm birth.

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