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- Edqvist, M., et al.
(författare)
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One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}
- 2020
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 21:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisting the woman during the second stage of labour. Methods/design: In this multicentre randomised controlled trial, 2946 women will be randomised to be assisted by one or two midwives during the second stage of labour. Women age 18–47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward. Five maternity wards comprising 19,500 births/year in different parts of Sweden will participate in this study. The sample size is powered to demonstrate a 50% reduction (from 4.1–2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree). Secondary outcomes will include maternal and neonatal outcomes, women’s experiences, midwives’ experiences of the intervention, incontinence, and pelvic floor symptoms. The primary analysis is intention to treat. Questionnaires will be sent to the women at 1 month and 1 year after the birth to assess women’s experiences, pain, incontinence, pelvic floor symptoms, sexual function, and mental health. Discussion: It is important for care during labour and birth to be evidence based. There is a strong desire among midwives to reduce the risk of severe perineal trauma. This may lead to new strategies and practices being implemented into practice without scientific evidence. The intervention might have negative side effects or unintended consequences. On the other hand, there is a possibility of the intervention improving care for women. Trial registration {2a}: ClinicalTrials.gov NCT03770962. Registered on 10 December 2018
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- Pettersson, K., et al.
(författare)
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Traction force during vacuum extraction : a prospective observational study
- 2015
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Ingår i: British Journal of Obstetrics and Gynecology. - : Wiley-Blackwell. - 1470-0328 .- 1471-0528. ; 122:13, s. 1809-1816
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveTo investigate the traction force employed during vacuum extractions. DesignObservational cross-sectional study. SettingObstetric Department, Karolinska University Hospital, Sweden, and the Swedish National Congress of Obstetrics and Gynaecology, 2013. PopulationTwo hundred women with vacuum extraction at term and 130 obstetricians participating in a simulated setting. MethodsIn a normal clinical setting, we used a specially adapted device to measure and record the force used to undertake vacuum extraction. In a subsequent part of the study, the force employed for vacuum extraction by a group of obstetricians in a fictive setting was estimated and objectively measured. Main outcome measuresApplied force during vacuum extraction in relation to the estimated level of difficulty in the delivery; perinatal diagnoses of asphyxia or head trauma; estimated force compared with objectively measured force employed in the fictive setting. ResultsThe median (minimum-maximum) peak forces for minimum, average and excessive vacuum extraction in the clinical setting were 176N (5-360N), 225N (115-436N), and 241N (164-452N), respectively. In 34% of cases a force in excess of 216N was employed. There was no correlation between the umbilical arterial pH at delivery and the traction force employed during extraction. Four cases of mild hypoxic ischaemic encephalopathy were observed, three of which were associated with a delivery whereby excessive traction force was employed during the vacuum extraction. In the fictive setting, the actual exerted force was twice the quantitative estimation. The measured forces in the clinical setting were four times higher than that estimated in the fictive setting. ConclusionsHigher than expected levels of traction force were used for vacuum extraction delivery. As obstetricians tend to underestimate the force applied during vacuum extraction, objective measurement with instantaneous feedback may be valuable in raising awareness.
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- Edqvist, Malin, et al.
(författare)
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The effect of two midwives during the second stage of labour to reduce severe perineal trauma (Oneplus) : a multicentre, randomised controlled trial in Sweden
- 2022
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 399:10331, s. 1242-1253
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Severe perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife.METHODS: In this multicentre, randomised, controlled parallel group, unmasked trial done at five obstetric units in Sweden, women were randomly assigned to be assisted by either one or two midwives in late second stage. Nulliparous women and women planning the first vaginal birth after caesarean section who were age 18-47 years were randomly assigned to an intervention when reaching the second stage of labour. Further inclusion criteria were gestational week 37+0, carrying a singleton live fetus in vertex presentation, and proficiency in either Swedish, English, Arabic, or Farsi. Exclusion criteria were a multiple pregnancy, intrauterine fetal demise, a planned caesarean section, or women who were less than 37 weeks pregnant. Randomisation to the intervention group of two midwives or standard care group of one midwife (1:1) was done using a computer-based program and treatment groups were allocated by use of sealed opaque envelopes. All women and midwives were aware of the group assignment, but the statistician from Clinical Studies Forum South, who did the analyses, was masked to group assignment. Midwives were instructed to implement existing prevention models and the second midwife was to assist on instruction of the primary midwife, when asked. Midwives were also instructed to complete case report forms detailing assistance techniques and perineal trauma prevention techniques. The primary outcome was the proportion of women who had SPT, for which odds ratios (ORs) and 95% CIs were calculated, and logistic regression was done to adjust for study site. All analyses were done according to intention to treat. The trial is registered with ClinicalTrials.gov, NCT0377096.FINDINGS: Between Dec 10, 2018, and March 21, 2020, 8866 women were assessed for eligibility, and 4264 met the inclusion criteria and agreed to participate. 3776 (88·5%) of 4264 women were randomly assigned to an intervention after reaching the second stage of labour. 1892 women were assigned to collegial assistance (two midwives) during the second stage of labour and 1884 women were assigned to standard care (one midwife). 13 women in each group did not meet the inclusion criteria and were excluded. After further exclusions, 1546 women spontaneously gave birth in the intervention group and 1513 in the standard care group. 1546 women in the intervention group and 1513 in the standard care group were included in the intention-to-treat analysis of the primary outcome. There was a significant reduction in SPT in the intervention group (3·9% [61 of 1546] vs 5·7% [86 of 1513]; adjusted OR 0·69 (0·49-0·97).INTERPRETATION: The presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time.
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| 16. |
- Edqvist, Malin, et al.
(författare)
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The Effect of Two Midwives During the Second Stage of Labour to Reduce Severe Perineal Trauma (Oneplus) : A Multicentre, Randomized Controlled Trial in Sweden
- 2022
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Ingår i: Obstetrical and Gynecological Survey. - : Ovid Technologies (Wolters Kluwer Health). - 0029-7828 .- 1533-9866. ; 77:9, s. 513-515
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Tidskriftsartikel (refereegranskat)abstract
- In many high-income countries, severe perinatal trauma (SPT), affecting the anal sphincter muscle complex, has been on the rise over the last decade. However, effective strategies to prevent SPT are scarce. In randomized controlled trials, only perineal warm compresses and massage have shown benefit. Other cohort studies have shown that prevention models involving several components can decrease the occurrence of SPT, including a stepped-wedge design that reduced SPT from 3.3% to 3.0%. In Scandinavia, a preventive strategy called collegial assistance has been used to help prevent SPT. This strategy involves 2 mid-wives who assist the woman in the second stage of labor, with the second midwife primarily focused on preventing SPT. The aim of this study was to compare the rate of SPT in pregnancies managed by collegial assistance versus a single midwife. This Oneplus study was a randomized, controlled, unmasked trial, conducted at 5 obstetric units in Sweden between December 10, 2018, and March 21, 2020. Included were adult women with uncomplicated singleton pregnancies at >37 weeks of gestation, who were carrying their first child or having their first vaginal birth after cesarean delivery. Excluded were women who had multiple pregnancies, had intrauterine fetal demise, were undergoing a planned cesarean section, or were at <37 weeks' gestation. Women were randomly assigned to either the intervention group with 2 midwives in attendance during active second stage labor or standard care with 1 midwife. All midwives were asked to document the preventive methods used in case report forms. A total of 3750 women were included in the final analysis-with 1879 women receiving collegial assistance and 1871 women receiving standard care. Of the women who gave birth spontaneously, 1546 were in the intervention group and 1513 in the standard care group. Severe perinatal trauma occurred less frequently in the intervention group than the standard care group (3.9% vs 5.7%; odds ratio, 0.68; 95% confidence interval, 0.49-0.97; P = 0.025). In the intervention group, 0.2% had fourth-degree tears compared with 0.5% in the standard care group. The median time for collegial assistance was 15 minutes (interquartile range, 10-20 minutes). The use of perineal warm compresses was similar in the intervention group and standard care group (86.4% vs 85.7%, respectively). No differences were observed in birth positions, manual perineal protection, neonatal outcomes, or secondary maternal outcomes. In conclusion, the attendance of a second midwife dedicated to preventing SPT during the second stage of labor significantly reduced the risk of injury.
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| 17. |
- Edqvist, Malin, et al.
(författare)
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The effect of two midwives during the second stage of labour to reduce severe perineal trauma (Oneplus) : a multicentre, randomised controlled trial in Sweden
- 2022
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Ingår i: The Lancet. - : Elsevier. - 0140-6736 .- 1474-547X. ; 399:10331, s. 1242-1253
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundSevere perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife.MethodsIn this multicentre, randomised, controlled parallel group, unmasked trial done at five obstetric units in Sweden, women were randomly assigned to be assisted by either one or two midwives in late second stage. Nulliparous women and women planning the first vaginal birth after caesarean section who were age 18–47 years were randomly assigned to an intervention when reaching the second stage of labour. Further inclusion criteria were gestational week 37+0, carrying a singleton live fetus in vertex presentation, and proficiency in either Swedish, English, Arabic, or Farsi. Exclusion criteria were a multiple pregnancy, intrauterine fetal demise, a planned caesarean section, or women who were less than 37 weeks pregnant. Randomisation to the intervention group of two midwives or standard care group of one midwife (1:1) was done using a computer-based program and treatment groups were allocated by use of sealed opaque envelopes. All women and midwives were aware of the group assignment, but the statistician from Clinical Studies Forum South, who did the analyses, was masked to group assignment. Midwives were instructed to implement existing prevention models and the second midwife was to assist on instruction of the primary midwife, when asked. Midwives were also instructed to complete case report forms detailing assistance techniques and perineal trauma prevention techniques. The primary outcome was the proportion of women who had SPT, for which odds ratios (ORs) and 95% CIs were calculated, and logistic regression was done to adjust for study site. All analyses were done according to intention to treat. The trial is registered with ClinicalTrials.gov, NCT0377096.FindingsBetween Dec 10, 2018, and March 21, 2020, 8866 women were assessed for eligibility, and 4264 met the inclusion criteria and agreed to participate. 3776 (88·5%) of 4264 women were randomly assigned to an intervention after reaching the second stage of labour. 1892 women were assigned to collegial assistance (two midwives) during the second stage of labour and 1884 women were assigned to standard care (one midwife). 13 women in each group did not meet the inclusion criteria and were excluded. After further exclusions, 1546 women spontaneously gave birth in the intervention group and 1513 in the standard care group. 1546 women in the intervention group and 1513 in the standard care group were included in the intention-to-treat analysis of the primary outcome. There was a significant reduction in SPT in the intervention group (3·9% [61 of 1546] vs 5·7% [86 of 1513]; adjusted OR 0·69 (0·49–0·97).InterpretationThe presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time.FundingThe Swedish Research Council for Health, Working Life and Welfare; Jan Hains Research Foundation; and Skane County Council's Research and Development Foundation.
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| 21. |
- Lindqvist, Pelle G., et al.
(författare)
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Identification of pregnancies at increased risk of brachial plexus birth palsy - the construction of a weighted risk score
- 2014
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Ingår i: Journal of Maternal-Fetal & Neonatal Medicine. - : Informa UK Limited. - 1476-7058 .- 1476-4954. ; 27:3, s. 252-256
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Since it is difficult to identify women at increased risk of fetal brachial plexus birth palsy (BPBP) during labor and delivery, we aimed to construct and validate a risk score. Methods: A retrospective case-control study was undertaken in 2001 and 2006 in an urban context in Malmo, Sweden. A risk score was constructed for all women who had received routine municipal maternal health care at Skane University Hospital (n = 10 459). The model was validated among all pregnant women with BPBP and controls in Sweden between 2006 and 2007. Results: The likelihood of BPBP increased as the risk score rose: 3.1% of the women studied had a risk score >= 5, including 32.1% of the BPBP cases, where the risk showed a 38-fold increase, as compared to those with a risk score <= 1 (2/3 of the population). Conclusion: Our findings indicate that it is possible to identify women at increased risk of having a child with BPBP by using variables observable in advance of delivery.
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| 31. |
- Tiblad, E, et al.
(författare)
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Procedure-related complications and perinatal outcome after intrauterine transfusions in red cell alloimmunization in Stockholm
- 2011
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Ingår i: Fetal diagnosis and therapy. - : S. Karger AG. - 1421-9964 .- 1015-3837. ; 30:4, s. 266-273
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Tidskriftsartikel (refereegranskat)abstract
- <i>Introduction:</i> We present a review of all cases of intravascular transfusions in red cell alloimmunization over a time span of 20 years in Stockholm. The aim of the study is to compare our results with published results from larger centers and to identify areas that can be further improved. <i>Material and Methods:</i> A retrospective cohort study was conducted of all women treated with intrauterine transfusions due to erythrocyte immunization in our hospital between June 1990 and June 2010. Primary outcome variables were fetal and neonatal survival, procedure-related complications and gestational age at delivery. <i>Results:</i> A total of 284 intrauterine transfusions were performed in 84 pregnancies, with an overall survival rate of 91.8%. Procedure-related and fatal complications occurred in the present study in 4.9 and 1.4% of fetuses or neonates, respectively. Procedure-related complications were significantly more common in free-loop transfusions than in transfusions in the intrahepatic part of the umbilical vein (OR: 5.4, p = 0.025). There was no significant difference between the intrahepatic and the placental cord insertion route (p = 0.83). Gestational age at first transfusion was significantly associated with an increased risk of a procedure-related complication (OR: 0.8, p = 0.019). Of the live-born infants, 24% of the neonates were born before gestational week 34. <i>Discussion:</i> Our study confirms previous studies demonstrating favorable results with intravascular transfusions.
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| 38. |
- Åmark, H., et al.
(författare)
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Single versus pairwise interpretation of cardiotochography, a comparative study from six Swedish delivery units
- 2014
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Ingår i: Sexual & Reproductive HealthCare. - : Elsevier. - 1877-5756 .- 1877-5764. ; 5:4, s. 195-198
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The aim of the study was to evaluate whether interpreting CTG pairwise brings about a higher level of correctly classified CTG recordings in a non-selected population of midwives and physicians. Study design: A comparative study. Setting: Five delivery units in Stockholm and one delivery unit in Uppsala, with 1589, 3740, 3908, 4539, 6438, and 7331 deliveries in 2011, respectively. Subjects: 536 midwives and physicians classified one randomly selected CTG recording individually followed by a pairwise classification. The pairs consisted of two midwives (119 pairs) or one midwife and one physician (149 pairs), a total of 268 pairs. Main outcome measure: The proportion of individually correctly classified CTG recordings versus the proportion of pairwise correctly classified CTG recordings. Results: The proportion of individually correctly classified CTG's was 75% and the proportion of pairwise correctly classified CTG's was 80% (difference 5%, p = 0.12). Conclusions: There was no statistically significant difference when CTG's were classified pairwise compared to individual classifications. The proportion of individually correctly classified CTG's was high (75%). There were differences in the proportion of correctly classified CTG recordings between the delivery units, indicating potential areas of improvement. © 2014 Elsevier B.V.
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