Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis.

BACKGROUND: Umbilical cord clamping strategies at preterm birth have the potential to affect important health outcomes. The aim of this study was to compare the effectiveness of deferred cord clamping, umbilical cord milking, and immediate cord clamping in reducing neonatal mortality and morbidity at preterm birth. METHODS: We conducted a systematic review and individual participant data meta-analysis. We searched medical databases and trial registries (from database inception until Feb 24, 2022; updated June 6, 2023) for randomised controlled trials comparing deferred (also known as delayed) cord clamping, cord milking, and immediate cord clamping for preterm births (<37 weeks' gestation). Quasi-randomised or cluster-randomised trials were excluded. Authors of eligible studies were invited to join the iCOMP collaboration and share individual participant data. All data were checked, harmonised, re-coded, and assessed for risk of bias following prespecified criteria. The primary outcome was death before hospital discharge. We performed intention-to-treat one-stage individual participant data meta-analyses accounting for heterogeneity to examine treatment effects overall and in prespecified subgroup analyses. Certainty of evidence was assessed with Grading of Recommendations Assessment, Development, and Evaluation. This study is registered with PROSPERO, CRD42019136640. FINDINGS: We identified 2369 records, of which 48 randomised trials provided individual participant data and were eligible for our primary analysis. We included individual participant data on 6367 infants (3303 [55%] male, 2667 [45%] female, two intersex, and 395 missing data). Deferred cord clamping, compared with immediate cord clamping, reduced death before discharge (odds ratio [OR] 0·68 [95% CI 0·51-0·91], high-certainty evidence, 20 studies, n=3260, 232 deaths). For umbilical cord milking compared with immediate cord clamping, no clear evidence was found of a difference in death before discharge (OR 0·73 [0·44-1·20], low certainty, 18 studies, n=1561, 74 deaths). Similarly, for umbilical cord milking compared with deferred cord clamping, no clear evidence was found of a difference in death before discharge (0·95 [0·59-1·53], low certainty, 12 studies, n=1303, 93 deaths). We found no evidence of subgroup differences for the primary outcome, including by gestational age, type of delivery, multiple birth, study year, and perinatal mortality. INTERPRETATION: This study provides high-certainty evidence that deferred cord clamping, compared with immediate cord clamping, reduces death before discharge in preterm infants. This effect appears to be consistent across several participant-level and trial-level subgroups. These results will inform international treatment recommendations. FUNDING: Australian National Health and Medical Research Council.

Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data.

BACKGROUND: Deferred (also known as delayed) cord clamping can improve survival of infants born preterm (before 37 weeks of gestation), but the optimal duration of deferral remains unclear. We conducted a systematic review and individual participant data network meta-analysis with the aim of comparing the effectiveness of umbilical cord clamping strategies with different timings of clamping or with cord milking for preterm infants. METHODS: We searched medical databases and trial registries from inception until Feb 24, 2022 (updated June 6, 2023) for randomised controlled trials comparing cord clamping strategies for preterm infants. Individual participant data were harmonised and assessed for risk of bias and quality. Interventions were grouped into immediate clamping, short deferral (≥15 s to <45 s), medium deferral (≥45 s to <120 s), long deferral (≥120 s), and intact cord milking. The primary outcome was death before hospital discharge. We calculated one-stage, intention-to-treat Bayesian random-effects individual participant data network meta-analysis. This study was registered with PROSPERO, CRD42019136640. FINDINGS: We included individual participant data from 47 trials with 6094 participants. Of all interventions, long deferral reduced death before discharge the most (compared with immediate clamping; odds ratio 0·31 [95% credibility interval] 0·11-0·80; moderate certainty). The risk of bias was low for 10 (33%) of 30 trials, 14 (47%) had some concerns, and 6 (20%) were rated as having a high risk of bias. Heterogeneity was low, with no indication of inconsistency. INTERPRETATION: This study found that long deferral of clamping leads to reduced odds of death before discharge in preterm infants. In infants assessed as requiring immediate resuscitation, this finding might only be generalisable if there are provisions for such care with the cord intact. These results are based on thoroughly cleaned and checked individual participant data and can inform future guidelines and practice. FUNDING: Australian National Health and Medical Research Council.

Antenatal cardiotocography for fetal assessment.

BACKGROUND: Cardiotocography (CTG) is a continuous recording of the fetal heart rate obtained via an ultrasound transducer placed on the mother's abdomen. CTG is widely used in pregnancy as a method of assessing fetal well-being, predominantly in pregnancies with increased risk of complications. OBJECTIVES: To assess the effectiveness of antenatal CTG (both traditional and computerised assessments) in improving outcomes for mothers and babies during and after pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (26 June 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised trials that compared traditional antenatal CTG with no CTG or CTG results concealed; computerised CTG with no CTG or CTG results concealed; and computerised CTG with traditional CTG. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: Six studies (involving 2105 women) are included. Overall, the included studies were not of high quality, and only two had both adequate randomisation sequence generation and allocation concealment. All studies that were able to be included enrolled only women at increased risk of complications.Comparison of traditional CTG versus no CTG showed no significant difference identified in perinatal mortality (risk ratio (RR) 2.05, 95% confidence interval (CI) 0.95 to 4.42, 2.3% versus 1.1%, four studies, N = 1627, low quality evidence) or potentially preventable deaths (RR 2.46, 95% CI 0.96 to 6.30, four studies, N = 1627), though the meta-analysis was underpowered to assess this outcome. Similarly, there was no significant difference identified in caesarean sections (RR 1.06, 95% CI 0.88 to 1.28, 19.7% versus 18.5%, three trials, N = 1279, low quality evidence). There was also no significant difference identified for secondary outcomes related to Apgar scores less than seven at five minutes (RR 0.83, 95% CI 0.37 to 1.88, one trial, N = 396, very low quality evidence); or admission to neonatal special care units or neonatal intensive care units (RR 1.08, 95% CI 0.84 to 1.39, two trials, N = 883, low quality evidence), nor in the other secondary outcomes that were assessed.There were no eligible studies that compared computerised CTG with no CTG.Comparison of computerised CTG versus traditional CTG showed a significant reduction in perinatal mortality with computerised CTG (RR 0.20, 95% CI 0.04 to 0.88, two studies, 0.9% versus 4.2%, 469 women, moderate quality evidence). However, there was no significant difference identified in potentially preventable deaths (RR 0.23, 95% CI 0.04 to 1.29, two studies, N = 469), though the meta-analysis was underpowered to assess this outcome. There was no significant difference identified in caesarean sections (RR 0.87, 95% CI 0.61 to 1.24, 63% versus 72%, one study, N = 59, low quality evidence), Apgar scores less than seven at five minutes (RR 1.31, 95% CI 0.30 to 5.74, two studies, N = 469, very low quality evidence) or in secondary outcomes. AUTHORS' CONCLUSIONS: There is no clear evidence that antenatal CTG improves perinatal outcome, but further studies focusing on the use of computerised CTG in specific populations of women with increased risk of complications are warranted.

Interventions for helping to turn term breech babies to head first presentation when using external cephalic version.

BACKGROUND: Breech presentation is associated with increased complications. Turning a breech baby to head first presentation using external cephalic version (ECV) attempts to reduce the chances of breech presentation at birth so as to avoid the adverse effects of breech vaginal birth or caesarean section. Interventions such as tocolytic drugs and other methods have been used in an attempt to facilitate ECV. OBJECTIVES: To assess, from the best evidence available, the effects of interventions such as tocolysis, acoustic stimulation for midline spine position, regional analgesia (epidural or spinal), transabdominal amnioinfusion, systemic opioids and hypnosis, or the use of abdominal lubricants, on ECV at term for successful version, presentation at birth, method of birth and perinatal and maternal morbidity and mortality. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2014) and the reference lists of identified studies. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing the above interventions with no intervention or other methods to facilitate ECV at term. DATA COLLECTION AND ANALYSIS: We assessed eligibility and trial quality. Two review authors independently assessed for inclusion all potential studies identified as a result of the search strategy and independently extracted the data using a specially designed data extraction form. MAIN RESULTS: We included 28 studies, providing data on 2786 women. We used the random-effects model for pooling data because of clinical heterogeneity between studies. A number of trial reports gave insufficient information to allow clear assessment of risk of bias. We used GradePro software to carry out formal assessments of quality of the evidence for beta stimulants versus placebo and regional analgesia with tocolysis versus tocolysis alone.Tocolytic parenteral beta stimulants were effective in increasing cephalic presentations in labour (average risk ratio (RR) 1.68, 95% confidence interval (CI) 1.14 to 2.48, five studies, 459 women, low-quality evidence) and in reducing the number of caesarean sections (average RR 0.77, 95% CI 0.67 to 0.88, six studies, 742 women, moderate-quality evidence). Failure to achieve a cephalic vaginal birth was less likely for women receiving a parenteral beta stimulant (average RR 0.75, 95% CI 0.60 to 0.92, four studies, 399 women, moderate-quality evidence). No clear differences in fetal bradycardias were identified, although this was reported for only one study, which was underpowered for assessing this outcome. Failed external cephalic version was reported in nine studies (900 women), and women receiving parenteral beta stimulants were less likely to have failure compared with controls (average RR 0.70, 95% CI 0.60 to 0.82, moderate-quality evidence). Perinatal mortality and serious morbidity were not reported. Sensitivity analysis by study quality was consistent with overall findings.For other classes of tocolytic drugs (calcium channel blockers and nitric oxide donors), evidence was insufficient to permit conclusions; outcomes were reported for only one or two studies, which were underpowered to demonstrate differences between treatment and control groups. Little evidence was found regarding adverse effects, although nitric oxide donors were associated with increased risk of headache. Data comparing different tocolytic drugs were insufficient.Regional analgesia in combination with a tocolytic was more effective than the tocolytic alone for increasing successful versions (assessed by the rate of failed ECVs; average RR 0.61, 95% CI 0.43 to 0.86, five studies, 409 women, moderate-quality evidence), and no difference was identified in cephalic presentation in labour (average RR 1.63, 95% CI 0.75 to 3.53, three studies, 279 women, very low-quality evidence), caesarean sections (average RR 0.74, 95% CI 0.40 to 1.37, three studies, 279 women, very low-quality evidence) nor fetal bradycardia (average RR 1.48, 95% CI 0.62 to 3.57, two studies, 210 women, low-quality evidence), although studies were underpowered for assessing these outcomes. Studies did not report on failure to achieve a cephalic vaginal birth (breech vaginal deliveries plus caesarean sections) nor on perinatal mortality or serious infant morbidity.Data were insufficient on the use of regional analgesia without tocolysis, vibroacoustic stimulation, amnioinfusion, systemic opioids and hypnosis, and on the use of talcum powder or gel to assist external cephalic version, to permit conclusions about their effectiveness and safety. AUTHORS' CONCLUSIONS: Parenteral beta stimulants were effective in facilitating successful ECV, increasing cephalic presentation in labour and reducing the caesarean section rate, but data on adverse effects were insufficient. Data on calcium channel blockers and nitric acid donors were insufficient to provide good evidence.The scope for further research is clear. Possible benefits of tocolysis in reducing the force required for successful version and possible risks of side effects need to be addressed further. Further trials are needed to compare the effectiveness of routine versus selective use of tocolysis and the role of regional analgesia, fetal acoustic stimulation, amnioinfusion and abdominal lubricants, and the effects of hypnosis, in facilitating ECV. Although randomised trials of nitric oxide donors are small, the results are sufficiently negative to discourage further trials. Intervention fidelity for ECV can be enhanced by standardisation of the techniques and processes used for clinical manipulation of the fetus in the abdominal cavity and ought to be the subject of further research.

Active versus expectant management for women in the third stage of labour.

BACKGROUND: Active management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries. OBJECTIVES: To compare the effectiveness of active versus expectant management of the third stage of labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 September 2014) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. MAIN RESULTS: We included seven studies (involving 8247 women), all undertaken in hospitals, six in high-income countries and one in a low-income country. Four studies compared active versus expectant management, and three compared active versus a mixture of managements. We used random-effects in the analyses because of clinical heterogeneity. There was an absence of high-quality evidence according to GRADE assessments for our primary outcomes. The evidence suggested that for women at mixed levels of risk of bleeding, active management showed a reduction in the average risk of maternal primary haemorrhage at time of birth (more than 1000 mL) (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, three studies, 4636 women, GRADE:very low quality) and of maternal haemoglobin (Hb) less than 9 g/dL following birth (average RR 0.50, 95% CI 0.30 to 0.83, two studies, 1572 women, GRADE:low quality). We also found no difference in the incidence in admission of infants to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, two studies, 3207 infants, GRADE:low quality) nor in the incidence of infant jaundice requiring treatment (0.96, 95% CI 0.55 to 1.68, two studies, 3142 infants, GRADE:very low quality). There were no data on our other primary outcomes of very severe postpartum haemorrhage (PPH) at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.Active management also showed a significant decrease in primary blood loss greater than 500 mL, and mean maternal blood loss at birth, maternal blood transfusion and therapeutic uterotonics during the third stage or within the first 24 hours, or both, and significant increases in maternal diastolic blood pressure, vomiting after birth, after-pains, use of analgesia from birth up to discharge from the labour ward and more women returning to hospital with bleeding (outcome not pre-specified). There was also a decrease in the baby's birthweight with active management, reflecting the lower blood volume from interference with placental transfusion.In the subgroup of women at low risk of excessive bleeding, there were similar findings, except there was no significant difference identified between groups for severe haemorrhage or maternal Hb less than 9 g/dL (at 24 to 72 hours).Hypertension and interference with placental transfusion might be avoided by using modifications to the active management package, e.g. omitting ergot and deferring cord clamping, but we have no direct evidence of this here. AUTHORS' CONCLUSIONS: Although there is a lack of high-quality evidence, active management of the third stage reduced the risk of haemorrhage greater than 1000 mL at the time of birth in a population of women at mixed risk of excessive bleeding, but adverse effects were identified. Women should be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.

Interventions at caesarean section for reducing the risk of aspiration pneumonitis.

BACKGROUND: Aspiration pneumonitis is a syndrome resulting from the inhalation of gastric contents. The incidence in obstetric anaesthesia has fallen, largely due to improved anaesthetic techniques and the increased use of regional anaesthesia at caesarean section. However, aspiration pneumonitis is still a cause of maternal morbidity and mortality, and it is important to use effective prophylaxis. OBJECTIVES: To determine whether interventions given prior to caesarean section reduce the risk of aspiration pneumonitis in women with an uncomplicated pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). SELECTION CRITERIA: Randomised controlled trials were included. Quasi-randomised trials were excluded. DATA COLLECTION AND ANALYSIS: Review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data entry was checked. Fixed-effect meta-analysis was used to combine data where it was reasonable to assume that studies were estimating the same underlying treatment effect. If substantial clinical or statistical heterogeneity was detected, we used random-effects analysis to produce an overall summary. MAIN RESULTS: Thirty-two studies were included in this review. However, only 22 studies, involving 2658 women, provided data for analysis. All the women in the included studies had a caesarean section under general anaesthesia. The studies covered a number of comparisons, but were mostly small and of unclear or poor quality.When compared with no treatment or placebo, there was a significant reduction in the risk of intragastric pH < 2.5 with antacids (risk ratio (RR) 0.17, 95% confidence interval (CI) 0.09 to 0.32, two studies, 108 women), H2 antagonists (RR 0.09, 95% CI 0.05 to 0.18, two studies, 170 women) and proton pump antagonists (RR 0.26, 95% CI 0.14 to 0.46, one study 80 women). H2 antagonists were associated with a reduced the risk of intragastric pH < 2.5 at intubation when compared with proton pump antagonists (RR 0.39, 95% CI 0.16 to 0.97, one study, 120 women), but compared with antacids the findings were unclear. The combined use of 'antacids plus H2 antagonists' was associated with a significant reduction in the risk of intragastric pH < 2.5 at intubation when compared with placebo (RR 0.02, 95% CI 0.00 to 0.15, one study, 89 women) or compared with antacids alone (RR 0.12, 95% CI 0.02 to 0.92, one study, 119 women). AUTHORS' CONCLUSIONS: The quality of the evidence was poor, but the findings suggest that the combination of antacids plus H2 antagonists was more effective than no intervention, and superior to antacids alone in preventing low gastric pH. However, none of the studies assessed potential adverse effects or substantive clinical outcomes. These findings are relevant for all women undergoing caesarean section under general anaesthesia.

Restricting oral fluid and food intake during labour.

BACKGROUND: Restricting fluids and foods during labour is common practice across many birth settings with some women only being allowed sips of water or ice chips. Restriction of oral intake may be unpleasant for some women, and may adversely influence their experience of labour. OBJECTIVES: To determine the benefits and harms of oral fluid or food restriction during labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2013) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs of restricting fluids and food for women in labour compared with women free to eat and drink. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. MAIN RESULTS: We identified 19 studies of which we included five, involving 3130 women. We excluded eight studies, one awaits classification and five are ongoing studies. All the included studies looked at women in active labour and at low risk of potentially requiring a general anaesthetic. One study looked at complete restriction versus giving women the freedom to eat and drink at will; two studies looked at water only versus giving women specific fluids and foods and two studies looked at water only versus giving women carbohydrate drinks.When comparing any restriction of fluids and food versus women given some nutrition in labour, the meta-analysis was dominated by one study undertaken in a highly medicalised environment. There were no statistically significant differences identified in: caesarean section (average risk ratio (RR) 0.89, 95% confidence interval (CI) 0.63 to 1.25, five studies, 3103 women), operative vaginal births (average RR 0.98, 95% CI 0.88 to 1.10, five studies, 3103 women) and Apgar scores less than seven at five minutes (average RR 1.43, 95% CI 0.77 to 2.68, four studies, 2902 infants), nor in any of the other outcomes assessed. Women's views were not assessed. The pooled data were insufficient to assess the incidence of Mendelson's syndrome, an extremely rare outcome. Other comparisons showed similar findings, except one study did report a significant increase in caesarean sections for women taking carbohydrate drinks in labour compared with water only, but these results should be interpreted with caution as the sample size was small. AUTHORS' CONCLUSIONS: Since the evidence shows no benefits or harms, there is no justification for the restriction of fluids and food in labour for women at low risk of complications. No studies looked specifically at women at increased risk of complications, hence there is no evidence to support restrictions in this group of women. Conflicting evidence on carbohydrate solutions means further studies are needed and it is critical in any future studies to assess women's views.

Fetal and umbilical Doppler ultrasound in high-risk pregnancies.

BACKGROUND: Abnormal blood flow patterns in fetal circulation detected by Doppler ultrasound may indicate poor fetal prognosis. It is also possible false positive Doppler ultrasound findings could encourage inappropriate early delivery. OBJECTIVES: The objective of this review was to assess the effects of Doppler ultrasound used to assess fetal well-being in high-risk pregnancies on obstetric care and fetal outcomes. SEARCH METHODS: We updated the search of the Cochrane Pregnancy and Childbirth Group's Trials Register on 30 September 2013. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of Doppler ultrasound for the investigation of umbilical and fetal vessels waveforms in high-risk pregnancies compared with no Doppler ultrasound. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data entry was checked. MAIN RESULTS: Eighteen completed studies involving just over 10,000 women were included. The trials were generally of unclear quality with some evidence of possible publication bias. The use of Doppler ultrasound in high-risk pregnancy was associated with a reduction in perinatal deaths (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.52 to 0.98, 16 studies, 10,225 babies, 1.2% versus 1.7 %, number needed to treat (NNT) = 203; 95% CI 103 to 4352). There were also fewer inductions of labour (average RR 0.89, 95% CI 0.80 to 0.99, 10 studies, 5633 women, random-effects) and fewer caesarean sections (RR 0.90, 95% CI 0.84 to 0.97, 14 studies, 7918 women). No difference was found in operative vaginal births (RR 0.95, 95% CI 0.80 to 1.14, four studies, 2813 women), nor in Apgar scores less than seven at five minutes (RR 0.92, 95% CI 0.69 to 1.24, seven studies, 6321 babies). AUTHORS' CONCLUSIONS: Current evidence suggests that the use of Doppler ultrasound in high-risk pregnancies reduced the risk of perinatal deaths and resulted in less obstetric interventions. The quality of the current evidence was not of high quality, therefore, the results should be interpreted with some caution. Studies of high quality with follow-up studies on neurological development are needed.

Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour.

BACKGROUND: Cardiotocography (known also as electronic fetal monitoring), records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic), so additional assessments of fetal well-being may be used, or the baby delivered by caesarean section or instrumental vaginal birth. OBJECTIVES: To evaluate the effectiveness of continuous cardiotocography during labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (31 December 2012) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with (a) no fetal monitoring, (b) intermittent auscultation (c) intermittent cardiotocography. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, quality and extracted data from included studies. MAIN RESULTS: Thirteen trials were included with over 37,000 women; only two were judged to be of high quality.Compared with intermittent auscultation, continuous cardiotocography showed no significant improvement in overall perinatal death rate (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.59 to 1.23, n = 33,513, 11 trials), but was associated with a halving of neonatal seizures (RR 0.50, 95% CI 0.31 to 0.80, n = 32,386, nine trials). There was no significant difference in cerebral palsy rates (RR 1.75, 95% CI 0.84 to 3.63, n = 13,252, two trials). There was a significant increase in caesarean sections associated with continuous cardiotocography (RR 1.63, 95% CI 1.29 to 2.07, n = 18,861, 11 trials). Women were also more likely to have an instrumental vaginal birth (RR 1.15, 95% CI 1.01 to 1.33, n = 18,615, 10 trials).Data for subgroups of low-risk, high-risk, preterm pregnancies and high-quality trials were consistent with overall results. Access to fetal blood sampling did not appear to influence the difference in neonatal seizures nor any other prespecified outcome. AUTHORS' CONCLUSIONS: Continuous cardiotocography during labour is associated with a reduction in neonatal seizures, but no significant differences in cerebral palsy, infant mortality or other standard measures of neonatal well-being. However, continuous cardiotocography was associated with an increase in caesarean sections and instrumental vaginal births. The challenge is how best to convey these results to women to enable them to make an informed choice without compromising the normality of labour.

Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term.

BACKGROUND: Vaginal examinations have become a routine intervention in labour as a means of assessing labour progress. Used at regular intervals, either alone or as a component of the partogram (a pre-printed form providing a pictorial overview of the progress of labour), the aim is to assess if labour is progressing physiologically, and to provide an early warning of slow progress. Abnormally slow progress can be a sign of labour dystocia, which is associated with maternal and fetal morbidity and mortality, particularly in low-income countries where appropriate interventions cannot easily be accessed. However, over-diagnosis of dystocia can lead to iatrogenic morbidity from unnecessary intervention (e.g. operative vaginal birth or caesarean section). It is, therefore, important to establish whether or not the routine use of vaginal examinations is an effective intervention, both as a diagnostic tool for true labour dystocia, and as an accurate measure of physiological labour progress. OBJECTIVES: To compare the effectiveness, acceptability and consequences of digital vaginal examination(s) (alone or within the context of the partogram) with other strategies, or different timings, to assess progress during labour at term. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2013) and reference lists of identified studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of vaginal examinations (including digital assessment of the consistency of the cervix, and the degree of dilation and position of the opening of the uterus (cervical os); and position and station of the fetal presenting part, with or without abdominal palpation) compared with other ways of assessing progress of labour. We also included studies assessing different timings of vaginal examinations. We excluded quasi-RCTs and cross-over trials. We also excluded trials with a primary focus on assessing progress of labour using the partogram (of which vaginal examinations is one component) as this is covered by another Cochrane review. However, studies where vaginal examinations were used within the context of the partogram were included if the studies were randomised according to the vaginal examination component. DATA COLLECTION AND ANALYSIS: Three review authors assessed the studies for inclusion in the review. Two authors undertook independent data extraction and assessed the risk of bias of each included study. A third review author also checked data extraction and risk of bias. Data entry was checked. MAIN RESULTS: We found two studies that met our inclusion criteria but they were of unclear quality. One study, involving 307 women, compared vaginal examinations with rectal examinations, and the other study, involving 150 women, compared two-hourly with four-hourly vaginal examinations. Both studies were of unclear quality in terms of risk of selection bias, and the study comparing the timing of the vaginal examinations excluded 27% (two hourly) to 28% (four hourly) of women after randomisation because they no longer met the inclusion criteria.When comparing routine vaginal examinations with routine rectal examinations to assess the progress of labour, we identified no difference in neonatal infections requiring antibiotics (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.01 to 8.07, one study, 307 infants). There were no data on the other primary outcomes of length of labour, maternal infections requiring antibiotics and women's overall views of labour. The study did show that significantly fewer women reported that vaginal examination was very uncomfortable compared with rectal examinations (RR 0.42, 95% CI 0.25 to 0.70, one study, 303 women). We identified no difference in the secondary outcomes of augmentation, caesarean section, spontaneous vaginal birth, operative vaginal birth, perinatal mortality and admission to neonatal intensive care.Comparing two-hourly vaginal examinations with four-hourly vaginal examinations in labour, we found no difference in length of labour (mean difference in minutes (MD) -6.00, 95% CI -88.70 to 76.70, one study, 109 women). There were no data on the other primary outcomes of maternal or neonatal infections requiring antibiotics, and women's overall views of labour. We identified no difference in the secondary outcomes of augmentation, epidural for pain relief, caesarean section, spontaneous vaginal birth and operative vaginal birth. AUTHORS' CONCLUSIONS: On the basis of women's preferences, vaginal examination seems to be preferred to rectal examination. For all other outcomes, we found no evidence to support or reject the use of routine vaginal examinations in labour to improve outcomes for women and babies. The two studies included in the review were both small, and carried out in high-income countries in the 1990s.  It is surprising that there is such a widespread use of this intervention without good evidence of effectiveness, particularly considering the sensitivity of the procedure for the women receiving it, and the potential for adverse consequences in some settings.The effectiveness of the use and timing of routine vaginal examinations in labour, and other ways of assessing progress in labour, including maternal behavioural cues, should be the focus of new research as a matter of urgency. Women's views of ways of assessing labour progress should be given high priority in any future research in this area.

Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period.

BACKGROUND: Perineal pain is a common but poorly studied adverse outcome following childbirth. Pain may result from perineal trauma due to bruising, spontaneous tears, surgical incisions (episiotomies), or in association with operative births (ventouse or forceps assisted births). OBJECTIVES: To determine the efficacy of a single administration of paracetamol (acetaminophen) systemic drugs used in the relief of acute postpartum perineal pain SEARCH METHODS: We updated the search of the Cochrane Pregnancy and Childbirth Group's Trials Register on 6 November 2012. SELECTION CRITERIA: Randomised controlled trials (RCTs) assessing paracetamol (acetaminophen) in a single dose compared with placebo for women with early postpartum perineal pain. We excluded quasi-RCTs and cross-over studies. DATA COLLECTION AND ANALYSIS: Two review authors assessed each paper for inclusion and extracted data. One review author reviewed the decisions and confirmed calculations for pain relief scores. MAIN RESULTS: We did not identify any new trials from the updated search so the results remain unchanged as follows.We have included 10 studies describing two dosages of paracetamol. Of these, five studies (526 women) assessed 500 mg to 650 mg and six studies (841 women) assessed 1000 mg of paracetamol. We chose to use random-effects meta-analyses because of the heterogeneity in dosage used. Studies were from the 1970s to the early 1990s, and there was insufficient information to assess the risk of bias adequately, hence the findings need to be interpreted within this context.More women experienced pain relief with paracetamol compared with placebo (average risk ratio (RR) 2.14, 95% confidence interval (CI) 1.59 to 2.89, 10 studies, 1279 women). In addition, there were significantly fewer women having additional pain relief with paracetamol compared with placebo (RR 0.34, 95% CI 0.21 to 0.55, eight studies, 1132 women). Both the 500 mg to 650 mg and 1000 mg doses were effective in providing more pain relief than placebo.Maternal and neonatal potential adverse drug effects were not assessed in any of the included studies. Indeed few secondary outcomes were assessed. AUTHORS' CONCLUSIONS: More women experienced pain relief, and fewer had additional pain relief, with paracetamol compared with placebo, although potential adverse effects were not assessed and generally the quality of studies was unclear.

Medical treatments for incomplete miscarriage.

BACKGROUND: Miscarriage occurs in 10% to 15% of pregnancies. The traditional treatment, after miscarriage, has been to perform surgery to remove any remaining placental tissues in the uterus ('evacuation of uterus'). However, medical treatments, or expectant care (no treatment), may also be effective, safe and acceptable. OBJECTIVES: To assess the effectiveness, safety and acceptability of any medical treatment for incomplete miscarriage (before 24 weeks). SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2012) and reference lists of retrieved papers. SELECTION CRITERIA: Randomised controlled trials comparing medical treatment with expectant care or surgery or alternative methods of medical treatment. Quasi-randomised trials were excluded. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data entry was checked. MAIN RESULTS: Twenty studies (4208 women) were included. There were no trials specifically of miscarriage treatment after 13 weeks' gestation.Three trials involving 335 women compared misoprostol treatment (all vaginally administered) with expectant care. There was no statistically significant difference in complete miscarriage (average risk ratio (RR) 1.23, 95% confidence interval (CI) 0.72 to 2.10; two studies, 150 women, random-effects), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; two studies, 308 women, random-effects). There were few data on 'deaths or serious complications'.Twelve studies involving 2894 women addressed the comparison of misoprostol (six studies used oral administration, four studies used vaginal, one study sub-lingual, one study combined vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.97, 95% CI 0.95 to 0.99, 11 studies, 2493 women, random-effects) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.06, 95% CI 0.02 to 0.13; 11 studies, 2654 women, random-effects) but more unplanned procedures (average RR 5.82, 95% CI 2.93 to 11.56; nine studies, 2274 women, random-effects). There were few data on 'deaths or serious complications'. Nausea was more common with misoprostol (average RR 2.41, 95% CI 1.44 to 4.03; nine studies, 2179 women, random-effects).Five trials compared different routes of administration and/or doses of misoprostol. There was no clear evidence of one regimen being superior to another. Limited evidence suggests that women generally seem satisfied with their care. Long-term follow-up from one included study identified no difference in subsequent fertility between the three approaches. AUTHORS' CONCLUSIONS: The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Women experiencing miscarriage at less than 13 weeks should be offered an informed choice. Future studies should include long-term follow-up.

Antenatal cardiotocography for fetal assessment.

BACKGROUND: Cardiotocography (CTG) is a continuous recording of the fetal heart rate obtained via an ultrasound transducer placed on the mother's abdomen. CTG is widely used in pregnancy as a method of assessing fetal well-being, predominantly in pregnancies with increased risk of complications. OBJECTIVES: To assess the effectiveness of antenatal CTG (both traditional and computerised assessments) in improving outcomes for mothers and babies during and after pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (9 July 2012) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised trials that compared traditional antenatal CTG with no CTG or CTG results concealed; computerised CTG with no CTG or CTG results concealed; and computerised CTG with traditional CTG. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed eligibility, quality and extracted data. MAIN RESULTS: Six studies (involving 2105 women) are included. Overall, the included studies were not of high quality, and only two had both adequate randomisation sequence generation and allocation concealment. All studies that were able to be included enrolled only women at increased risk of complications.Comparison of traditional CTG versus no CTG showed no significant difference identified in perinatal mortality (risk ratio (RR) 2.05, 95% confidence interval (CI) 0.95 to 4.42, 2.3% versus 1.1%, four studies, N = 1627) or potentially preventable deaths (RR 2.46, 95% CI 0.96 to 6.30, four studies, N = 1627), though the meta-analysis was underpowered to assess this outcome. Similarly, there was no significant difference identified in caesarean sections (RR 1.06, 95% CI 0.88 to 1.28, 19.7% versus 18.5%, three trials, N = 1279) nor in the secondary outcomes that were assessed.There were no eligible studies that compared computerised CTG with no CTG.Comparison of computerised CTG versus traditional CTG showed a significant reduction in perinatal mortality with computerised CTG (RR 0.20, 95% CI 0.04 to 0.88, two studies, 0.9% versus 4.2%, 469 women). However, there was no significant difference identified in potentially preventable deaths (RR 0.23, 95% CI 0.04 to 1.29, two studies, N = 469), though the meta-analysis was underpowered to assess this outcome. There was no significant difference identified in caesarean sections (RR 0.87, 95% CI 0.61 to 1.24, 63% versus 72%, one study, N = 59) or in secondary outcomes. AUTHORS' CONCLUSIONS: There is no clear evidence that antenatal CTG improves perinatal outcome, but further studies focusing on the use of computerised CTG in specific populations of women with increased risk of complications are warranted.

Caesarean section for non-medical reasons at term.

BACKGROUND: Caesarean section rates are progressively rising in many parts of the world. One suggested reason is increasing requests by women for caesarean section in the absence of clear medical indications, such as placenta praevia, HIV infection, contracted pelvis and, arguably, breech presentation or previous caesarean section. The reported benefits of planned caesarean section include greater safety for the baby, less pelvic floor trauma for the mother, avoidance of labour pain and convenience. The potential disadvantages, from observational studies, include increased risk of major morbidity or mortality for the mother, adverse psychological sequelae, and problems in subsequent pregnancies, including uterine scar rupture and a greater risk of stillbirth and neonatal morbidity. The differences in neonatal physiology following vaginal and caesarean births are thought to have implications for the infant, with caesarean section potentially increasing the risk of compromised health in both the short and the long term. An unbiased assessment of advantages and disadvantages would assist discussion of what has become a contentious issue in modern obstetrics. OBJECTIVES: To assess, from randomised trials, the effects on perinatal and maternal morbidity and mortality, and on maternal psychological morbidity, of planned caesarean delivery versus planned vaginal birth in women with no clear clinical indication for caesarean section. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2012) and reference lists of relevant studies. SELECTION CRITERIA: All comparisons of intention to perform caesarean section and intention for women to give birth vaginally; random allocation to treatment and control groups; adequate allocation concealment; women at term with single fetuses with cephalic presentations and no clear medical indication for caesarean section. DATA COLLECTION AND ANALYSIS: We identified no studies that met the inclusion criteria. MAIN RESULTS: There were no included trials. AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials, upon which to base any practice recommendations regarding planned caesarean section for non-medical reasons at term. In the absence of trial data, there is an urgent need for a systematic review of observational studies and a synthesis of qualitative data to better assess the short- and long-term effects of caesarean section and vaginal birth.

Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section.

BACKGROUND: Nausea and vomiting are distressing symptoms which are experienced commonly during caesarean section under regional anaesthesia and can also occur in the period following the procedure.  OBJECTIVES: To assess the efficacy of pharmacological and non-pharmacological interventions given prophylactically to prevent nausea and vomiting in women undergoing regional anaesthesia for caesarean section. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 February 2012) and reference lists of identified studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and excluded quasi-RCTs and cross-over studies. DATA COLLECTION AND ANALYSIS: Review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data entry was checked.   MAIN RESULTS: Fifty-two studies met the inclusion criteria but only 41 studies, involving 5046 women, provided useable data for the review involving women having caesareans under regional anaesthesia. The majority of the studies involved women undergoing elective caesarean section. Only two studies included emergency surgery, however, they did not stratify data according to type of surgery. The studies covered numerous comparisons, but the majority of studies involved 5-HT(3) receptor antagonists, dopamine receptor antagonists, corticosteroids or acupressure. Studies were mainly small and of unclear quality.Three classes of intervention were found to be effective in at least three out of four of our primary outcomes (intraoperative nausea, intraoperative vomiting, postoperative nausea and postoperative vomiting). These interventions were 5-HT(3) antagonists, dopamine antagonists and sedatives. Other classes of intervention were effective for fewer than three of our primary outcomes.With 5-HT antagonists, we found a reduction in intraoperative nausea (average risk ratio (RR) 0.64, 95% confidence interval (CI) 0.46 to 0.88, eight studies, 720 women). There were also reductions in postoperative nausea (average RR 0.40, 95% CI 0.25 to 0.64, four studies, 405 women) and vomiting (average RR 0.50, 95% CI 0.32 to 0.77, five studies, 565 women). We did not detect a significant reduction in intraoperative vomiting (average RR 0.56, 95% CI 0.31 to 1.00, seven studies, 668 women).Dopamine antagonists demonstrated a reduction in intraoperative nausea (average RR 0.38, 95% CI 0.25 to 0.57, nine studies, 636 women) and intraoperative vomiting (average 0.39, 95% CI 0.24 to 0.64, eight studies, 536 women), with similar reductions in postoperative nausea (average RR 0.60, 95% CI 0.40 to 0.91, five studies, 412 women) and vomiting (average RR 0.57, 95% CI 0.36 to 0.91, six studies, 472 women). These differences were observed with both metoclopramide and droperidol.Sedatives (most commonly propofol) demonstrated a reduction in intraoperative nausea (average RR 0.71, 95% CI 0.52 to 0.96, four studies, 285 women) and intraoperative vomiting (average RR 0.42, 95% CI 0.26 to 0.68, four studies, 285 women), also with a reduction in postoperative nausea (average RR 0.25, 95% CI 0.09 to 0.71, two studies 145 women) and vomiting (average RR 0.09, 95% CI 0.03 to 0.28, two studies, 145 women).Acupressure was found to be effective for intraoperative nausea (average RR 0.59, 95% CI 0.38 to 0.90, six studies, 649 women) but not postoperative nausea (average RR 0.83, 95% CI 0.68 to 1.00, three studies, 429 women). Acupressure was not effective at reducing vomiting either intraoperatively (average RR 0.74, 95% CI 0.46 to 1.18, six studies, 649 women) or postoperatively (average RR 0.69, 95% CI 0.45 to 1.06, three studies, 429 women).Other effective intervention classes included corticosteroids, antihistamines, and anticholinergics.There were insufficient data to demonstrate any class of intervention was superior to another. There were no significant differences observed in the comparison of combined versus single interventions.Few studies assessed our secondary outcomes or the incidence of adverse effects. However, one study showed an increase in respiratory depression with sedation (midazolam) compared with dopamine antagonists. AUTHORS' CONCLUSIONS: This review indicates that many different interventions have efficacy in preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. There is little evidence that combinations of treatment are better than single agents.

Active versus expectant management for women in the third stage of labour.

BACKGROUND: Active management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries. OBJECTIVES: To compare the effectiveness of active versus expectant management of the third stage of labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (15 February 2011). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. MAIN RESULTS: We included seven studies (involving 8247 women), all undertaken in hospitals, six in high-income countries and one in a low-income country. Four studies compared active versus expectant management, and three compared active versus a mixture of managements. We used random-effects in the analyses because of clinical heterogeneity. There was an absence of high quality evidence for our primary outcomes. The evidence suggested that for women at mixed levels of risk of bleeding, active management showed a reduction in the average risk of maternal primary haemorrhage at time of birth (more than 1000 mL) (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, three studies, 4636 women) and of maternal haemoglobin (Hb) less than 9 g/dL following birth (average RR 0.50, 95% CI 0.30 to 0.83, two studies, 1572 women). We also found no difference in the incidence in admission of infants to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, two studies, 3207 women) nor in the incidence of infant jaundice requiring treatment (0.96, 95% CI 0.55 to 1.68, two studies, 3142 women). There were no data on our other primary outcomes of very severe postpartum haemorrhage (PPH) at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.Active management also showed a significant decrease in primary blood loss greater than 500 mL, and mean maternal blood loss at birth, maternal blood transfusion and therapeutic uterotonics during the third stage or within the first 24 hours, or both and significant increases in maternal diastolic blood pressure, vomiting after birth, after-pains, use of analgesia from birth up to discharge from the labour ward and more women returning to hospital with bleeding (outcome not pre-specified). There was also a decrease in the baby's birthweight with active management, reflecting the lower blood volume from interference with placental transfusion.In the subgroup of women at low risk of excessive bleeding, there were similar findings, except there was no significant difference identified between groups for severe haemorrhage or maternal Hb less than 9 g/dL (at 24 to 72 hours).Hypertension and interference with placental transfusion might be avoided by using modifications to the active management package, e.g. omitting ergot and deferring cord clamping, but we have no direct evidence of this here. AUTHORS' CONCLUSIONS: Although there is a lack of high quality evidence, active management of the third stage reduced the risk of haemorrhage greater than 1000 mL at the time of birth in a population of women at mixed risk of excessive bleeding, but adverse effects were identified. Women should be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.

Umbilical Cord Management for Newborns <34 Weeks' Gestation: A Meta-analysis.

CONTEXT: The International Liaison Committee on Resuscitation prioritized scientific review of umbilical cord management strategies at preterm birth. OBJECTIVE: To determine the effects of umbilical cord management strategies (including timing of cord clamping and cord milking) in preterm infants <34 weeks' gestation. DATA SOURCES: Cochrane Central Register of Controlled Trials, Medline, PubMed, Embase, CINAHL, and trial registries were searched through July 2019 for randomized controlled trials assessing timing of cord clamping and/or cord milking. STUDY SELECTION: Two authors independently assessed trial eligibility, extracted data, appraised risk of bias, and assessed evidence certainty (GRADE). DATA EXTRACTION: We identified 42 randomized controlled trials (including 5772 infants) investigating 4 different comparisons of cord management interventions. RESULTS: Compared to early cord clamping, delayed cord clamping (DCC) and intact-cord milking (ICM) may slightly improve survival; however, both are compatible with no effect (DCC: risk ratio: 1.02, 95% confidence interval: 1.00 to 1.04, n = 2988 infants, moderate certainty evidence; ICM: risk ratio: 1.02, 95% confidence interval: 0.98 to 1.06, n = 945 infants, moderate certainty evidence). DCC and ICM both probably improve hematologic measures but may not affect major neonatal morbidities. LIMITATIONS: For many of the included comparisons and outcomes, certainty of evidence was low. Our subgroup analyses were limited by few researchers reporting subgroup data. CONCLUSIONS: DCC appears to be associated with some benefit for infants born <34 weeks. Cord milking needs further evidence to determine potential benefits or harms. The ideal cord management strategy for preterm infants is still unknown, but early clamping may be harmful.