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1.
  • Elden, Helen, 1959, et al. (author)
  • Acupuncture as an adjunct to standard treatment for pelvic girdle pain in pregnant women: randomised double-blinded controlled trial comparing acupuncture with non-penetrating sham acupuncture
  • 2008
  • In: BJOG : an international journal of obstetrics and gynaecology. - : Wiley. - 1471-0528 .- 1470-0328. ; 115:13, s. 1655-68
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: To investigate whether acupuncture has a greater treatment effect than non-penetrating sham acupuncture in women with pelvic girdle pain (PGP) during pregnancy. DESIGN: Randomised double-blinded controlled trial. SETTING: East Hospital, Gothenburg, and 25 antenatal primary care units in the region of Västra Götaland, Sweden. POPULATION: A total of 115 pregnant women with a clinical diagnosis of PGP who scored > or =50 on a 100-mm visual analogue scale (VAS). METHOD: Women were randomly allocated to standard treatment plus acupuncture or to standard treatment plus non-penetrating sham acupuncture for 8 weeks. MAIN OUTCOME MEASURES: Main outcome measure was pain. Secondary outcomes were frequency of sick leave, functional status, discomfort of PGP, health-related quality of life and recovery of severity of PGP as assessed by the independent examiner. RESULTS: After treatment, median pain decreased from 66 to 36 in the acupuncture group and from 69 to 41 in the non-penetrating sham group (P = 0.493) as assessed on a VAS. Women in the acupuncture group were in regular work to a higher extent than women in the sham group (n = 28/57 versus 16/57, P = 0.041). The acupuncture group had superior ability to perform daily activities measured with the disability rating index (DRI) (44 versus 55, P = 0.001). There were no significant differences in quality of life, discomfort of PGP and recovery from severity of PGP between the groups. CONCLUSIONS: Acupuncture had no significant effect on pain or on the degree of sick leave compared with non-penetrating sham acupuncture. There was some improvement in performing daily activities according to DRI. The data imply that needle penetration contributes to a limited extent to the previously reported beneficial effects of acupuncture.
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2.
  • Elden, Helen, 1959, et al. (author)
  • Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial
  • 2005
  • In: Bmj. ; 330:7494, s. 761-764
  • Journal article (peer-reviewed)abstract
    • OBJECTIVES: To compare the efficacy of standard treatment, standard treatment plus acupuncture, and standard treatment plus stabilising exercises for pelvic girdle pain during pregnancy. DESIGN: Randomised single blind controlled trial. Settings East Hospital, Gothenburg, and 27 maternity care centres in Sweden. PARTICIPANTS: 386 pregnant women with pelvic girdle pain. INTERVENTIONS: Treatment for six weeks with standard treatment (n = 130), standard treatment plus acupuncture (n = 125), or standard treatment plus stabilising exercises (n = 131). MAIN OUTCOME MEASURES: Primary outcome measure was pain (visual analogue scale); secondary outcome measure was assessment of severity of pelvic girdle pain by an independent examiner before and after treatment. RESULTS: After treatment the stabilising exercise group had less pain than the standard group in the morning (median difference = 9, 95% confidence interval 1.7 to 12.8; P = 0.0312) and in the evening (13, 2.7 to 17.5; P = 0.0245). The acupuncture group, in turn, had less pain in the evening than the stabilising exercise group (-14, -18.1 to -3.3; P = 0.0130). Furthermore, the acupuncture group had less pain than the standard treatment group in the morning (12, 5.9 to 17.3; P < 0.001) and in the evening (27, 13.3 to 29.5; P < 0.001). Attenuation of pelvic girdle pain as assessed by the independent examiner was greatest in the acupuncture group. CONCLUSION: Acupuncture and stabilising exercises constitute efficient complements to standard treatment for the management of pelvic girdle pain during pregnancy. Acupuncture was superior to stabilising exercises in this study.
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3.
  • Elden, Helen, 1959, et al. (author)
  • Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial
  • 2004
  • In: The 5th Interdisciplinary World Congress on Low Back Pain & Pelvic Pain”, 2004, Melbourne.. - 9080255149
  • Conference paper (peer-reviewed)abstract
    • OBJECTIVES: To compare the efficacy of standard treatment, standard treatment plus acupuncture, and standard treatment plus stabilising exercises for pelvic girdle pain during pregnancy. DESIGN: Randomised single blind controlled trial. Settings East Hospital, Gothenburg, and 27 maternity care centres in Sweden. PARTICIPANTS: 386 pregnant women with pelvic girdle pain. INTERVENTIONS: Treatment for six weeks with standard treatment (n = 130), standard treatment plus acupuncture (n = 125), or standard treatment plus stabilising exercises (n = 131). MAIN OUTCOME MEASURES: Primary outcome measure was pain (visual analogue scale); secondary outcome measure was assessment of severity of pelvic girdle pain by an independent examiner before and after treatment. RESULTS: After treatment the stabilising exercise group had less pain than the standard group in the morning (median difference = 9, 95% confidence interval 1.7 to 12.8; P = 0.0312) and in the evening (13, 2.7 to 17.5; P = 0.0245). The acupuncture group, in turn, had less pain in the evening than the stabilising exercise group (-14, -18.1 to -3.3; P = 0.0130). Furthermore, the acupuncture group had less pain than the standard treatment group in the morning (12, 5.9 to 17.3; P < 0.001) and in the evening (27, 13.3 to 29.5; P < 0.001). Attenuation of pelvic girdle pain as assessed by the independent examiner was greatest in the acupuncture group. CONCLUSION: Acupuncture and stabilising exercises constitute efficient complements to standard treatment for the management of pelvic girdle pain during pregnancy. Acupuncture was superior to stabilising exercises in this study.
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4.
  • Elden, Helen, 1959, et al. (author)
  • Regression of pelvic girdle pain after delivery: follow-up of a randomised single blind controlled trial with different treatment modalities
  • 2008
  • In: Acta obstetricia et gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 87:2, s. 201-8
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: An earlier publication showed that acupuncture and stabilising exercises as an adjunct to standard treatment was effective for pelvic girdle pain during pregnancy, but the post-pregnancy effects of these treatment modalities are unknown. The aim of this follow-up study was to describe regression of pelvic girdle pain after delivery in these women. DESIGN: A randomised, single blind, controlled trial. SETTING: East Hospital and 27 maternity care centres in Göteborg, Sweden. POPULATION: Some 386 pregnant women with pelvic girdle pain. METHODS: Participants were randomly assigned to standard treatment plus acupuncture (n=125), standard treatment plus specific stabilising exercises (n=131) or to standard treatment alone (n=130). MAIN OUTCOME MEASURES: Primary outcome measures: pain intensity (Visual Analogue Scale). Secondary outcome measure: assessment of the severity of pelvic girdle pain by an independent examiner 12 weeks after delivery. RESULTS: Approximately three-quarters of all the women were free of pain 3 weeks after delivery. There were no differences in recovery between the 3 treatment groups. According to the detailed physical examination, pelvic girdle pain had resolved in 99% of the women 12 weeks after delivery. CONCLUSIONS: This study shows that irrespective of treatment modality, regression of pelvic girdle pain occurs in the great majority of women within 12 weeks after delivery.
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5.
  • Elden, Helen, 1959, et al. (author)
  • Regression of pelvic girdle pain after delivery: follow-up of a randomised single blind controlled trial with different treatment modalities
  • 2007
  • In: The 6th Interdiciplinary World Congress on Low Back Pain & Pelvic Pain, 2007 Barcelona.. - 9080255114
  • Conference paper (peer-reviewed)abstract
    • OBJECTIVE: An earlier publication showed that acupuncture and stabilising exercises as an adjunct to standard treatment was effective for pelvic girdle pain during pregnancy, but the post-pregnancy effects of these treatment modalities are unknown. The aim of this follow-up study was to describe regression of pelvic girdle pain after delivery in these women. DESIGN: A randomised, single blind, controlled trial. SETTING: East Hospital and 27 maternity care centres in Göteborg, Sweden. POPULATION: Some 386 pregnant women with pelvic girdle pain. METHODS: Participants were randomly assigned to standard treatment plus acupuncture (n=125), standard treatment plus specific stabilising exercises (n=131) or to standard treatment alone (n=130). MAIN OUTCOME MEASURES: Primary outcome measures: pain intensity (Visual Analogue Scale). Secondary outcome measure: assessment of the severity of pelvic girdle pain by an independent examiner 12 weeks after delivery. RESULTS: Approximately three-quarters of all the women were free of pain 3 weeks after delivery. There were no differences in recovery between the 3 treatment groups. According to the detailed physical examination, pelvic girdle pain had resolved in 99% of the women 12 weeks after delivery. CONCLUSIONS: This study shows that irrespective of treatment modality, regression of pelvic girdle pain occurs in the great majority of women within 12 weeks after delivery.
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6.
  • Elden, Helen, 1959, et al. (author)
  • Treatmentmodalities for pelvic girdle pain during pregnancy
  • 2010
  • In: NMAC, Nordisk akupunktur kongress , Aug 2010, Åland..
  • Conference paper (peer-reviewed)abstract
    • Pelvic girdle pain (PGP) affects about 20% of pregnant women. It causes great suffering for the individual and high costs for society. Persisting PGP have been reported in 10 to 75% three months after pregnancy and some women have also stated that PGP has been the beginning of a chronic condition. Risk factors for PGP are history of low back pain, history of PGP or trauma to the pelvis. Available evidence of research of treatment for the condition is insufficient to recommend any particular treatment modality for PGP. Also, the use of acupuncture for PGP is sparse due to insufficient documentation of adverse effects of this treatment in this specific condition. The main purpose of this thesis was to study efficacy, safety and post pregnancy effects of standard treatment, acupuncture and stabilising exercises given to pregnant women with PGP. Based on this knowledge, our ultimate aim is to increase our knowledge about treatment of PGP. METHODS: Paper I reports on a randomised single-blind trial comparing efficacy of standard treatment plus acupuncture, standard treatment plus stabilising exercises and standard treatment alone in 386 pregnant women with diagnosed PGP. Paper II is a follow up study of the original randomised trial in which adverse effects during pregnancy and delivery, influence on the mother, fetus, pregnancy and the pregnancy outcome are reported. Paper III describes regression of PGP during 12 weeks after pregnancy among these women. Paper IV reports on a double-blind randomised trial in which effects of penetrating acupuncture and non-penetrating sham acupuncture as adjunct to standard treatment are compared in 115 pregnant women with diagnosed PGP. The aim with this study was to investigate if specific treatment effects of penetrating acupuncture go beyond effects of non-specific effects and individual attention. RESULTS: Acupuncture as well as stabilising exercises as adjunct to standard treatment constituted efficient complements to standard treatment for the management of PGP during pregnancy. Acupuncture administered with a stimulation that may be considered strong lead to minor adverse complaints on the mothers but had no observable severe adverse influences on the pregnancy, mother, delivery or the fetus/ neonate. Regression of PGP after delivery was excellent with no differences in recovery between the three treatment groups. Both penetrating acupuncture and non-penetrating sham acupuncture lead to clinically relevant decrease of median pain after treatment but there were no significant difference between groups. Those who had received penetrating acupuncture were in regular work to a higher extent than those women that received non-penetrating sham acupuncture. The penetrating acupuncture group had superior ability in 7 of 13 daily activities (dressing; outdoor walks; climbing stairs, standing bent over a sink; running; heavy work and lifting heavy objects) than the non-penetrating sham acupuncture group. CONCLUSION: We have shown that acupuncture and stabilizing exercises as adjunct to standard treatment are effective for PGP during pregnancy. Even if our study was of insufficient size to exclude negative effects on delivery, perinatal morbidity and mortality as well as on CTG the study result adds support to the view that acupuncture even with stimulation that may be considered as strong is not accompanied by any severe adverse influences on the pregnant women or the fetus/neonate. Even if more studies are required, our data provides the most comprehensive data reported to date. Our data suggest that irrespective of treatment modality, regression of PGP occurs in the great majority of women within 12 weeks after delivery. Penetrating acupuncture had no additional effect on PGP reduction compared to non-penetrating sham acupuncture but it improved the ability to perform daily activities keeping more women in regular work. Thus, the data imply that needle penetration contributes to the previously reported beneficial effects of acupuncture
  •  
7.
  • Elden, Helen, 1959, et al. (author)
  • Treatmentmodalities for pelvic girdle pain during pregnancy
  • 2009
  • In: Acupuncture in Medicine. ; 27:4
  • Conference paper (peer-reviewed)abstract
    • Pelvic girdle pain (PGP) affects about 20% of pregnant women. It causes great suffering for the individual and high costs for society. Persisting PGP have been reported in 10 to 75% three months after pregnancy and some women have also stated that PGP has been the beginning of a chronic condition. Risk factors for PGP are history of low back pain, history of PGP or trauma to the pelvis. Available evidence of research of treatment for the condition is insufficient to recommend any particular treatment modality for PGP. Also, the use of acupuncture for PGP is sparse due to insufficient documentation of adverse effects of this treatment in this specific condition. The main purpose of this thesis was to study efficacy, safety and post pregnancy effects of standard treatment, acupuncture and stabilising exercises given to pregnant women with PGP. Based on this knowledge, our ultimate aim is to increase our knowledge about treatment of PGP. METHODS: Paper I reports on a randomised single-blind trial comparing efficacy of standard treatment plus acupuncture, standard treatment plus stabilising exercises and standard treatment alone in 386 pregnant women with diagnosed PGP. Paper II is a follow up study of the original randomised trial in which adverse effects during pregnancy and delivery, influence on the mother, fetus, pregnancy and the pregnancy outcome are reported. Paper III describes regression of PGP during 12 weeks after pregnancy among these women. Paper IV reports on a double-blind randomised trial in which effects of penetrating acupuncture and non-penetrating sham acupuncture as adjunct to standard treatment are compared in 115 pregnant women with diagnosed PGP. The aim with this study was to investigate if specific treatment effects of penetrating acupuncture go beyond effects of non-specific effects and individual attention. RESULTS: Acupuncture as well as stabilising exercises as adjunct to standard treatment constituted efficient complements to standard treatment for the management of PGP during pregnancy. Acupuncture administered with a stimulation that may be considered strong lead to minor adverse complaints on the mothers but had no observable severe adverse influences on the pregnancy, mother, delivery or the fetus/ neonate. Regression of PGP after delivery was excellent with no differences in recovery between the three treatment groups. Both penetrating acupuncture and non-penetrating sham acupuncture lead to clinically relevant decrease of median pain after treatment but there were no significant difference between groups. Those who had received penetrating acupuncture were in regular work to a higher extent than those women that received non-penetrating sham acupuncture. The penetrating acupuncture group had superior ability in 7 of 13 daily activities (dressing; outdoor walks; climbing stairs, standing bent over a sink; running; heavy work and lifting heavy objects) than the non-penetrating sham acupuncture group. CONCLUSION: We have shown that acupuncture and stabilizing exercises as adjunct to standard treatment are effective for PGP during pregnancy. Even if our study was of insufficient size to exclude negative effects on delivery, perinatal morbidity and mortality as well as on CTG the study result adds support to the view that acupuncture even with stimulation that may be considered as strong is not accompanied by any severe adverse influences on the pregnant women or the fetus/neonate. Even if more studies are required, our data provides the most comprehensive data reported to date. Our data suggest that irrespective of treatment modality, regression of PGP occurs in the great majority of women within 12 weeks after delivery. Penetrating acupuncture had no additional effect on PGP reduction compared to non-penetrating sham acupuncture but it improved the ability to perform daily activities keeping more women in regular work. Thus, the data imply that needle penetration contributes to the previously reported beneficial effects of acupuncture
  •  
8.
  • Elden, Helen, 1959, et al. (author)
  • Treatmentmodalities for pelvic girdle pain during pregnancy.
  • 2008
  • In: SFOG (Svensk förening för obstetrik och gynekologi), 2008, Luleå..
  • Conference paper (peer-reviewed)abstract
    • Pelvic girdle pain (PGP) affects about 20% of pregnant women. It causes great suffering for the individual and high costs for society. Persisting PGP have been reported in 10 to 75% three months after pregnancy and some women have also stated that PGP has been the beginning of a chronic condition. Risk factors for PGP are history of low back pain, history of PGP or trauma to the pelvis. Available evidence of research of treatment for the condition is insufficient to recommend any particular treatment modality for PGP. Also, the use of acupuncture for PGP is sparse due to insufficient documentation of adverse effects of this treatment in this specific condition. The main purpose of this thesis was to study efficacy, safety and post pregnancy effects of standard treatment, acupuncture and stabilising exercises given to pregnant women with PGP. Based on this knowledge, our ultimate aim is to increase our knowledge about treatment of PGP. METHODS: Paper I reports on a randomised single-blind trial comparing efficacy of standard treatment plus acupuncture, standard treatment plus stabilising exercises and standard treatment alone in 386 pregnant women with diagnosed PGP. Paper II is a follow up study of the original randomised trial in which adverse effects during pregnancy and delivery, influence on the mother, fetus, pregnancy and the pregnancy outcome are reported. Paper III describes regression of PGP during 12 weeks after pregnancy among these women. Paper IV reports on a double-blind randomised trial in which effects of penetrating acupuncture and non-penetrating sham acupuncture as adjunct to standard treatment are compared in 115 pregnant women with diagnosed PGP. The aim with this study was to investigate if specific treatment effects of penetrating acupuncture go beyond effects of non-specific effects and individual attention. RESULTS: Acupuncture as well as stabilising exercises as adjunct to standard treatment constituted efficient complements to standard treatment for the management of PGP during pregnancy. Acupuncture administered with a stimulation that may be considered strong lead to minor adverse complaints on the mothers but had no observable severe adverse influences on the pregnancy, mother, delivery or the fetus/ neonate. Regression of PGP after delivery was excellent with no differences in recovery between the three treatment groups. Both penetrating acupuncture and non-penetrating sham acupuncture lead to clinically relevant decrease of median pain after treatment but there were no significant difference between groups. Those who had received penetrating acupuncture were in regular work to a higher extent than those women that received non-penetrating sham acupuncture. The penetrating acupuncture group had superior ability in 7 of 13 daily activities (dressing; outdoor walks; climbing stairs, standing bent over a sink; running; heavy work and lifting heavy objects) than the non-penetrating sham acupuncture group. CONCLUSION: We have shown that acupuncture and stabilizing exercises as adjunct to standard treatment are effective for PGP during pregnancy. Even if our study was of insufficient size to exclude negative effects on delivery, perinatal morbidity and mortality as well as on CTG the study result adds support to the view that acupuncture even with stimulation that may be considered as strong is not accompanied by any severe adverse influences on the pregnant women or the fetus/neonate. Even if more studies are required, our data provides the most comprehensive data reported to date. Our data suggest that irrespective of treatment modality, regression of PGP occurs in the great majority of women within 12 weeks after delivery. Penetrating acupuncture had no additional effect on PGP reduction compared to non-penetrating sham acupuncture but it improved the ability to perform daily activities keeping more women in regular work. Thus, the data imply that needle penetration contributes to the previously reported beneficial effects of acupuncture
  •  
9.
  • Elden, Helen, 1959, et al. (author)
  • Treatmentmodalities for pelvic girdle pain during pregnancy
  • 2007
  • In: Riksstämman, 2007, Göteborg.
  • Conference paper (peer-reviewed)abstract
    • Pelvic girdle pain (PGP) affects about 20% of pregnant women. It causes great suffering for the individual and high costs for society. Persisting PGP have been reported in 10 to 75% three months after pregnancy and some women have also stated that PGP has been the beginning of a chronic condition. Risk factors for PGP are history of low back pain, history of PGP or trauma to the pelvis. Available evidence of research of treatment for the condition is insufficient to recommend any particular treatment modality for PGP. Also, the use of acupuncture for PGP is sparse due to insufficient documentation of adverse effects of this treatment in this specific condition. The main purpose of this thesis was to study efficacy, safety and post pregnancy effects of standard treatment, acupuncture and stabilising exercises given to pregnant women with PGP. Based on this knowledge, our ultimate aim is to increase our knowledge about treatment of PGP. METHODS: Paper I reports on a randomised single-blind trial comparing efficacy of standard treatment plus acupuncture, standard treatment plus stabilising exercises and standard treatment alone in 386 pregnant women with diagnosed PGP. Paper II is a follow up study of the original randomised trial in which adverse effects during pregnancy and delivery, influence on the mother, fetus, pregnancy and the pregnancy outcome are reported. Paper III describes regression of PGP during 12 weeks after pregnancy among these women. Paper IV reports on a double-blind randomised trial in which effects of penetrating acupuncture and non-penetrating sham acupuncture as adjunct to standard treatment are compared in 115 pregnant women with diagnosed PGP. The aim with this study was to investigate if specific treatment effects of penetrating acupuncture go beyond effects of non-specific effects and individual attention. RESULTS: Acupuncture as well as stabilising exercises as adjunct to standard treatment constituted efficient complements to standard treatment for the management of PGP during pregnancy. Acupuncture administered with a stimulation that may be considered strong lead to minor adverse complaints on the mothers but had no observable severe adverse influences on the pregnancy, mother, delivery or the fetus/ neonate. Regression of PGP after delivery was excellent with no differences in recovery between the three treatment groups. Both penetrating acupuncture and non-penetrating sham acupuncture lead to clinically relevant decrease of median pain after treatment but there were no significant difference between groups. Those who had received penetrating acupuncture were in regular work to a higher extent than those women that received non-penetrating sham acupuncture. The penetrating acupuncture group had superior ability in 7 of 13 daily activities (dressing; outdoor walks; climbing stairs, standing bent over a sink; running; heavy work and lifting heavy objects) than the non-penetrating sham acupuncture group. CONCLUSION: We have shown that acupuncture and stabilizing exercises as adjunct to standard treatment are effective for PGP during pregnancy. Even if our study was of insufficient size to exclude negative effects on delivery, perinatal morbidity and mortality as well as on CTG the study result adds support to the view that acupuncture even with stimulation that may be considered as strong is not accompanied by any severe adverse influences on the pregnant women or the fetus/neonate. Even if more studies are required, our data provides the most comprehensive data reported to date. Our data suggest that irrespective of treatment modality, regression of PGP occurs in the great majority of women within 12 weeks after delivery. Penetrating acupuncture had no additional effect on PGP reduction compared to non-penetrating sham acupuncture but it improved the ability to perform daily activities keeping more women in regular work. Thus, the data imply that needle penetration contributes to the previously reported beneficial effects of acupuncture
  •  
10.
  • Elden, Helen, 1959, et al. (author)
  • Treatments of pelvic girdle pain in pregnant women: adverse effects of standard treatment, acupuncture and stabilising exercises on the pregnancy, mother, delivery and the fetus/neonate
  • 2008
  • In: BMC complementary and alternative medicine. - : Springer Science and Business Media LLC. - 1472-6882. ; 8
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Previous publications indicate that acupuncture is efficient for the treatment of pelvic girdle pain, PGP, in pregnant women. However, the use of acupuncture for PGP is rare due to insufficient documentation of adverse effects of this treatment in this specific condition. The aim of the present work was to assess adverse effects of acupuncture on the pregnancy, mother, delivery and the fetus/neonate in comparison with women that received stabilising exercises as adjunct to standard treatment or standard treatment alone. METHODS: In all, 386 women with PGP entered this controlled, single-blind trial. They were randomly assigned to standard treatment plus acupuncture (n = 125), standard treatment plus specific stabilising exercises (n = 131) or to standard treatment alone (n = 130) for 6 weeks. Acupuncture that may be considered strong was used and treatment was started as early as in the second trimester of pregnancy. Adverse effects were recorded during treatment and throughout the pregnancy. Influence on the fetus was measured with cardiotocography (CTG) before-during and after 43 acupuncture sessions in 43 women. A standardised computerized method to analyze the CTG reading numerically (Oxford 8000, Oxford, England) was used. After treatment, the women rated their overall experience of the treatment and listed adverse events if any in a questionnaire. Data of analgesia and oxytocin augmentation during labour, duration of labour, frequency of preterm birth, operative delivery, Apgar score, cord-blood gas/acid base balance and birth weight were also recorded. RESULTS: There were no serious adverse events after any of the treatments. Minor adverse events were common in the acupuncture group but women rated acupuncture favourably even despite this. The computerized or visually assessed CTG analyses of antenatal recordings in connection with acupuncture were all normal. CONCLUSION: This study shows that acupuncture administered with a stimulation that may be considered strong led to minor adverse complaints from the mothers but had no observable severe adverse influences on the pregnancy, mother, delivery or the fetus/neonate.
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