| 1. |
- Alkmark, Mårten, 1973, et al.
(författare)
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Induction of labour at 41 weeks or expectant management until 42 weeks: A systematic review and an individual participant data meta-analysis of randomised trials.
- 2020
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Ingår i: PLoS medicine. - : Public Library of Science (PLoS). - 1549-1676 .- 1549-1277. ; 17:12
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Tidskriftsartikel (refereegranskat)abstract
- The risk of perinatal death and severe neonatal morbidity increases gradually after 41 weeks of pregnancy. Several randomised controlled trials (RCTs) have assessed if induction of labour (IOL) in uncomplicated pregnancies at 41 weeks will improve perinatal outcomes. We performed an individual participant data meta-analysis (IPD-MA) on this subject.We searched PubMed, Excerpta Medica dataBASE (Embase), The Cochrane Library, Cumulative Index of Nursing and Allied Health Literature (CINAHL), and PsycINFO on February 21, 2020 for RCTs comparing IOL at 41 weeks with expectant management until 42 weeks in women with uncomplicated pregnancies. Individual participant data (IPD) were sought from eligible RCTs. Primary outcome was a composite of severe adverse perinatal outcomes: mortality and severe neonatal morbidity. Additional outcomes included neonatal admission, mode of delivery, perineal lacerations, and postpartum haemorrhage. Prespecified subgroup analyses were conducted for parity (nulliparous/multiparous), maternal age (<35/≥35 years), and body mass index (BMI) (<30/≥30). Aggregate data meta-analysis (MA) was performed to include data from RCTs for which IPD was not available. From 89 full-text articles, we identified three eligible RCTs (n = 5,161), and two contributed with IPD (n = 4,561). Baseline characteristics were similar between the groups regarding age, parity, BMI, and higher level of education. IOL resulted overall in a decrease of severe adverse perinatal outcome (0.4% [10/2,281] versus 1.0% [23/2,280]; relative risk [RR] 0.43 [95% confidence interval [CI] 0.21 to 0.91], p-value 0.027, risk difference [RD] -57/10,000 [95% CI -106/10,000 to -8/10,000], I2 0%). The number needed to treat (NNT) was 175 (95% CI 94 to 1,267). Perinatal deaths occurred in one (<0.1%) versus eight (0.4%) pregnancies (Peto odds ratio [OR] 0.21 [95% CI 0.06 to 0.78], p-value 0.019, RD -31/10,000, [95% CI -56/10,000 to -5/10,000], I2 0%, NNT 326, [95% CI 177 to 2,014]) and admission to a neonatal care unit ≥4 days occurred in 1.1% (24/2,280) versus 1.9% (46/2,273), (RR 0.52 [95% CI 0.32 to 0.85], p-value 0.009, RD -97/10,000 [95% CI -169/10,000 to -26/10,000], I2 0%, NNT 103 [95% CI 59 to 385]). There was no difference in the rate of cesarean delivery (10.5% versus 10.7%; RR 0.98, [95% CI 0.83 to 1.16], p-value 0.81) nor in other important perinatal, delivery, and maternal outcomes. MA on aggregate data showed similar results. Prespecified subgroup analyses for the primary outcome showed a significant difference in the treatment effect (p = 0.01 for interaction) for parity, but not for maternal age or BMI. The risk of severe adverse perinatal outcome was decreased for nulliparous women in the IOL group (0.3% [4/1,219] versus 1.6% [20/1,264]; RR 0.20 [95% CI 0.07 to 0.60], p-value 0.004, RD -127/10,000, [95% CI -204/10,000 to -50/10,000], I2 0%, NNT 79 [95% CI 49 to 201]) but not for multiparous women (0.6% [6/1,219] versus 0.3% [3/1,264]; RR 1.59 [95% CI 0.15 to 17.30], p-value 0.35, RD 27/10,000, [95% CI -29/10,000 to 84/10,000], I2 55%). A limitation of this IPD-MA was the risk of overestimation of the effect on perinatal mortality due to early stopping of the largest included trial for safety reasons after the advice of the Data and Safety Monitoring Board. Furthermore, only two RCTs were eligible for the IPD-MA; thus, the possibility to assess severe adverse neonatal outcomes with few events was limited.In this study, we found that, overall, IOL at 41 weeks improved perinatal outcome compared with expectant management until 42 weeks without increasing the cesarean delivery rate. This benefit is shown only in nulliparous women, whereas for multiparous women, the incidence of mortality and morbidity was too low to demonstrate any effect. The magnitude of risk reduction of perinatal mortality remains uncertain. Women with pregnancies approaching 41 weeks should be informed on the risk differences according to parity so that they are able to make an informed choice for IOL at 41 weeks or expectant management until 42 weeks. Study Registration: PROSPERO CRD42020163174.
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| 3. |
- Mgaya, Andrew Hans
(författare)
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Improving the quality of caesarean section in a low-resource setting : An intervention by criteria-based audit at a tertiary hospital, Dar es Salaam, Tanzania
- 2017
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- A sharp increase in caesarean section (CS) rates at the Muhimbili National Referral Hospital (MNH) – a tertiary referral hospital in Tanzania – by 50% in 2000–2011, was associated with concomitant increase in maternal complications and deaths and inconsistent improvement in newborn outcomes. The aims of this thesis were to explore care providers’ in-depth perspective of the reasons for these high rates of CS, and to evaluate and improve standards of care for the most common indica-tions of CS, obstructed labour and fetal distress, which are also major causes of adverse maternal and neonatal outcomes.This thesis reports an investigation performed at MNH, Tanzania. For Paper I, qualitative methods were employed and demonstrated how care providers dismissed their responsibility for the rising CS rate; and, instead, projected the causes onto factors beyond their control. Additionally, dysfunctinal teamwork, transparency, and previous poorly conducted clinical audits led to fear of blame among care providers in cases of poor outcome that subsequently encougared defensive practise by assigning unnecessary CS. Papers II and III evaluated stand-ards of care using a criteria-based audit (CBA) of obstructed labour and fetal dis-tress. After implementing audit-feedback recommendations, the standards of diag-nosis of fetal distress improved by 16% and obstructed labour by 7%. Similarly, the standards of management preceding CS improved tenfold for fetal distress and doubled for obstructed labour. The impact of the CBA process was evaluated by comparing the maternal and perinatal outcomes categorized into Robson groups (Paper IV) of all deliveries occurring before and after the audit process (n=27,960). After the CBA process, there was a 50% risk reduction of severe perinatal morbidi-ty/mortality for patients with obstructed labour. The overall CS rates increased by 10%, and this was attributed to an increase in the CS rate among breech, term preg-nancies (Robson group 6), and preterm pregnancies (Robson group 10) that specifi-cally had reduced risk of poor perinatal outcome. The overall neonatal distress rates were also reduced by 20%, and this was attributed to a decrease in the neonatal distress rate among low-risk, term pregnancies (Robson group 3). Importantly, the increased rates of poor perinatal outcomes were associated with referred patients that had higher risk of neonatal distress and PMR than non–referred patients, after CBA process. In conclusion, the studies managed to educate the care providers to take on their roles as decision-makers and medical experts to minimize unnecessary CS, using the available resources. Care providers’ commitment to achieve the best practice should be sustained and effort for stepwise upgrading quality of obstetric care should be supported by the hospital management from the primary to tertiary referral level.
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