| 1. |
- Nilvér, Helena, et al.
(författare)
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Women's childbirth experiences in the Swedish Post-term Induction Study (SWEPIS) : a multicentre, randomised, controlled trial
- 2021
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 11:4
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study.DESIGN: A register-based, multicentre, randomised, controlled, superiority trial.SETTING: Women were recruited at 14 hospitals in Sweden, 2016-2018.PARTICIPANTS: Women with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks.INTERVENTIONS: The women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379).OUTCOME MEASURES: As main outcome, women's childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1-10) within 3 days after delivery at the remaining eleven hospitals.RESULTS: The total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales: own capacity (2.8 vs 2.7, p=0.09), perceived safety (3.3 vs 3.2, p=0.06) and professional support (3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscale participation (3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22). CONCLUSIONS: There were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high.TRIAL REGISTRATION NUMBER: ISRCTN26113652.
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| 2. |
- Wennerholm, Ulla-Britt, 1948, et al.
(författare)
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Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS) : multicentre, open label, randomised, superiority trial
- 2019
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Ingår i: The BMJ. - : BMJ Publishing Group Ltd. - 1756-1833 .- 0959-8138. ; 367
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks.DESIGN: Multicentre, open label, randomised controlled superiority trial.SETTING: 14 hospitals in Sweden, 2016-18.PARTICIPANTS: 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group.INTERVENTIONS: Induction of labour at 41 weeks and expectant management and induction of labour at 42 weeks.MAIN OUTCOME MEASURES: The primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat.RESULTS: The study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups.CONCLUSIONS: This study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths.TRIAL REGISTRATION: Current Controlled Trials ISRCTN26113652.
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| 4. |
- Alkmark, Mårten, 1973, et al.
(författare)
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Induction of labour at 41 weeks of gestation versus expectant management and induction of labour at 42 weeks of gestation: a cost-effectiveness analysis
- 2022
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Ingår i: BJOG: An International Journal of Obstetrics and Gynaecology. - : Wiley. - 1470-0328 .- 1471-0528. ; 129:13, s. 2157-2165
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To assess the cost-effectiveness of induction of labour (IOL) at 41 weeks of gestation compared with expectant management until 42 weeks of gestation. Design: A cost-effectiveness analysis alongside the Swedish Post-term Induction Study (SWEPIS), a multicentre, randomised controlled superiority trial. Setting: Fourteen Swedish hospitals during 2016–2018. Population: Women with an uncomplicated singleton pregnancy with a fetus in cephalic position were randomised at 41 weeks of gestation to IOL or to expectant management and induction at 42 weeks of gestation. Methods: Health benefits were measured in life years and quality-adjusted life years (QALYs) for mother and child. Total cost per birth was calculated, including healthcare costs from randomisation to discharge after delivery, for mother and child. Incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in mean cost between the trial arms by the difference in life years and QALYs, respectively. Sampling uncertainty was evaluated using non-parametric bootstrapping. Main outcome measures: The cost per gained life year and per gained QALY. Results: The differences in life years and QALYs gained were driven by the difference in perinatal mortality alone. The absolute risk reduction in mortality was 0.004 (from 6/1373 to 0/1373). Based on Swedish life tables, this gives a mean gain in discounted life years and QALYs of 0.14 and 0.12 per birth, respectively. The mean cost per birth was €4108 in the IOL group (n = 1373) and €4037 in the expectant management group (n = 1373), with a mean difference of €71 (95% CI −€232 to €379). The ICER for IOL compared with expectant management was €545 per life year gained and €623 per QALY gained. Confidence intervals were relatively wide and included the possibility that IOL had both lower costs and better health outcomes. Conclusions: Induction of labour at 41 weeks of gestation results in a better health outcome and no significant difference in costs. IOL is cost-effective compared with expectant management until 42 weeks of gestation using standard threshold values for acceptable cost per life year/QALY. Tweetable abstract: Induction of labour at 41 weeks of gestation is cost-effective compared with expectant management until 42 weeks of gestation.
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| 6. |
- Kuusela, Pihla, et al.
(författare)
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Second trimester cervical length measurements with transvaginal ultrasound : a prospective observational agreement and reliability study
- 2020
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons. - 0001-6349 .- 1600-0412. ; 99:11, s. 1476-1485
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Universal screening for preterm delivery by adding transvaginal ultrasound measurement of cervical length to routine second trimester ultrasound has been proposed. The aim is to estimate inter- and intra-observer agreement and reliability of second trimester transvaginal ultrasound measurements of cervical length performed by specially trained midwife sonographers.MATERIAL AND METHODS: This is a prospective reliability and agreement study performed in seven Swedish ultrasound centers. In total, 18 midwife sonographers specially trained to perform ultrasound measurements of cervical length and 286 women in the second trimester were included. In each center two midwife sonographers measured cervical length a few minutes apart in the same woman, the number of women examined per examiner pair varying between 24 and 30 (LIVE study). Sixteen midwife sonographers measured cervical length twice ≥2 months apart on 93 video-clips (CLIPS study). The main outcome measures were mean difference, limits of agreement, intra-class correlation coefficient, intra-individual standard deviation, repeatability, Cohen´s kappa, and Fleiss kappa.RESULTS: The limits of agreement and intra-class correlation coefficient of the best examiner pair in the LIVE study were -4.06 to 4.72 mm and 0.91, those of the poorest were -11.11 to 11.39 mm and 0.31. In the CLIPS study, median (range) intra-individual standard deviation was 2.14 mm (1.40 to 3.46), repeatability 5.93 mm (3.88 to 9.58), intra-class correlation coefficient 0.84 (0.66 to 0.94). Median (range) inter-observer agreement for cervical length ≤25 mm in the CLIPS study was 94.6% (84.9% to 98.9%) and Cohen´s kappa 0.56 (0.12 to 0.92), median (range) intra-observer agreement was 95.2% (87.1% to 98.9%) and Cohen´s kappa 0.68 (0.27 to 0.93).CONCLUSIONS: Agreement and reliability of cervical length measurements differed substantially between examiner pairs and examiners. If cervical length measurements are used to guide management there is potential for both over- and under-treatment. Uniform training and rigorous supervision and quality control are advised.
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| 7. |
- Kuusela, Pihla, et al.
(författare)
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Second trimester transvaginal ultrasound measurement of cervical length for prediction of preterm birth : a blinded prospective multicentre diagnostic accuracy study
- 2021
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Ingår i: British Journal of Obstetrics and Gynecology. - : Wiley-Blackwell Publishing Inc.. - 1470-0328 .- 1471-0528. ; 128:2, s. 195-206
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To estimate the diagnostic performance of sonographic cervical length for prediction of preterm birth (PTB).DESIGN: Prospective observational multicentre study.SETTING: Seven Swedish ultrasound centres.SAMPLE: 11456 asymptomatic women with a singleton pregnancy.METHODS: Cervical length was measured with transvaginal ultrasound at 18 to 20 weeks (Cx1) and at 21 to 23 weeks (Cx2; optional). Staff and participants were blinded to results.MAIN OUTCOME MEASURES: Area under receiver operating characteristic curve (AUC), sensitivity, specificity, positive and negative predictive values (PPV, NPV), positive and negative likelihood ratios (LR+, LR-), number of false positive results per true positive result (FP/TP), number needed to screen to detect one PTB (NNS), prevalence of "short" cervix.RESULTS: Spontaneous PTB (sPTB) <33 weeks occurred in 56/11072 (0.5%) women in the Cx1 population (89% white ethnicity) and in 26/6288 (0.4%) in the Cx2 population (92% white ethnicity). The discriminative ability of shortest endocervical length was better the earlier the sPTB occurred and better at Cx2 than at Cx1 (AUC to predict sPTB <33 weeks 0.76 versus 0.65, difference in AUC 0.11, 95% CI 0.01 to 0.23). At Cx2, shortest endocervical length ≤25 mm (prevalence 4.4%) predicted sPTB <33 weeks with sensitivity 38.5% (10/26), specificity 95.8% (5998/6262), PPV 3.6% (10/274), NPV 99.7% (5988/6014), LR+ 9.1, LR- 0.64, 26 FP/TP, 629 NNS.CONCLUSION: Second trimester sonographic cervical length can identify women at high risk of sPTB. In a population of mainly white women and low prevalence of sPTB its diagnostic performance is at best moderate.
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| 8. |
- Wikström, Tove, et al.
(författare)
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Effect of second-trimester sonographic cervical length on the risk of spontaneous preterm delivery in different risk groups : a prospective observational multicenter study
- 2021
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons. - 0001-6349 .- 1600-0412. ; 100:9, s. 1644-1655
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: The aim of the study is to compare the effect of cervical length measured with transvaginal ultrasound in the second trimester on the risk of spontaneous preterm delivery between different risk groups of asymptomatic women with a singleton pregnancy.MATERIAL AND METHODS: This is a pre-planned exploratory analysis of the CERVIX study, a prospective blinded multicenter diagnostic accuracy study. Asymptomatic women with a singleton pregnancy were consecutively recruited at their second-trimester routine ultrasound examination at seven Swedish ultrasound centers. Cervical length was measured with transvaginal ultrasound at 18-20 weeks (Cx1; n=11 072) and 21-23 weeks (Cx2, optional; n=6288). The effect of cervical length on the risk of spontaneous preterm delivery and its discriminative ability was compared between women with: i. previous spontaneous preterm delivery, late miscarriage or cervical conization (high-risk group; n=1045); ii. nulliparae without risk factors (n=5173); iii. parae without risk factors (n=4740). Women with previous indicated preterm delivery were excluded (n=114). Main outcome measures were: effect of cervical length on the risk of spontaneous preterm delivery expressed as odds ratio per 5 mm decrease in cervical length with interaction analysis using logistic regression to test if the effect differed between groups, area under the receiver operating characteristic curve (AUC), sensitivity, specificity, number needed to screen to detect one spontaneous preterm delivery.RESULTS: The effect of cervical length at Cx2 on the risk of spontaneous preterm delivery <33 weeks was similar in all groups (odds ratios 2.26 to 2.58, interaction P-value 0.91). The discriminative ability at Cx2 was superior to that at Cx1 and was similar in all groups (AUC 0.69 to 0.76). Cervical length ≤25 mm at Cx2 identified 57% of spontaneous preterm deliveries <33 weeks in the high-risk group with number needed to screen 161. The number needed to screen for groups ii and iii were 1018 and 843.CONCLUSIONS: The effect of cervical length at 21-23 weeks on the risk of spontaneous preterm delivery <33 weeks is similar in high- and low-risk pregnancies. The differences in number needed to screen should be considered before implementing a screening program.
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