Immediate birth for women between 34 and 37 weeks of gestation with prolonged preterm prelabour rupture of membranes and detection of vaginal or urine group B streptococcus: an economic evaluation.

OBJECTIVE: What are the costs, benefits and harms of immediate birth compared with expectant management in women with prolonged preterm prelabour rupture of membranes (PPROM) at 34+0 -36+6  weeks of gestation and detection of vaginal or urine group B streptococcus (GBS)? DESIGN: Mathematical decision model comprising three independent decision trees. SETTING: UK National Health Service (NHS) and personal social services perspective. POPULATION: Women testing positive for GBS with PPROM at 34+0 -36+6  weeks of gestation. METHODS: The model estimates lifetime costs and quality-adjusted life years (QALYs) using evidence from randomised trials, UK NHS data sources and further observational studies. Simulated events include neonatal infections, morbidity associated with preterm birth and consequences of caesarean birth. Deterministic and probabilistic sensitivity analyses (PSAs) were performed. MAIN OUTCOME MEASURES: QALYs, costs and incremental cost-effectiveness ratio (ICER). RESULTS: In this population, immediate birth dominates expectant management: it is more effective (average lifetime QALYs, 24.705 versus 24.371) and it is cheaper (average lifetime costs, £14,372 versus £19,311). In one-way sensitivity analysis, results are robust to all but the odds ratio estimating the relative effect on incidence of infections. Threshold analysis shows that the odds of infection only need to be >1.5% with expectant management for the benefit of avoiding infections to outweigh the disadvantages of immediate birth. In PSA, immediate birth is the preferred option in >80% of simulations. CONCLUSIONS: Neonatal GBS infections are expensive to treat and may result in substantial adverse health consequences. Therefore, immediate birth, which is associated with a reduced risk of neonatal infection compared with expectant management, is expected to generate better health outcomes and decreased lifetime costs. TWEETABLE ABSTRACT: For women with preterm prelabour rupture of membranes and group B streptococcus in vaginal or urine samples, immediate birth is associated with improved health in their babies and reduced costs, compared with expectant management.

Incapacity in childbirth - Rare or common?

OBJECTIVE: Impaired decision making ability is common on general medical wards. Audit evidence suggests that the prevalence of incapacity may be higher than previously assumed in Obstetric Emergency Procedures (OEP) during childbirth. We investigated the prevalence of incapacity in OEP and factors associated with this. DESIGN: Capacity to consent to treatment was assessed retrospectively in 93 women undergoing OEP. All women were interviewed using a semi-structured questionnaire aided interview within 24 h of the emergency. Five assessors (3 obstetricians and 2 psychiatrists) were asked to determine capacity to consent from audio recordings of the interviews. RESULTS: All 5 assessors determined 59 % of women to have capacity to consent to treatment and 2 % of women to lack capacity. In 39 % of women there was some disagreement between assessors. Using a majority decision (3 assessors in agreement), 14 % of women lacked capacity. High pain scores, young age and no previous history of theatre deliveries were associated with more incapacity judgments, whilst parity and history of mental illness were not. Using a 7point Likert scale only marginally improved agreement between assessors, compared to their binary decision. CONCLUSION: It is often assumed that it is rare to lack capacity in an obstetric emergency procedure during childbirth, but these data suggest that incapacity may be relatively common. In particular, severe pain is a demonstrable risk factor for impaired capacity. Wide variation between assessors questions the validity of current commonly employed (informal) methods used in clinical practice to assess capacity to consent during OEP.

Central Fetal Monitoring With and Without Computer Analysis: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether intrapartum fetal monitoring with computer analysis and real-time alerts decreases the rate of newborn metabolic acidosis or obstetric intervention when compared with visual analysis. METHODS: A randomized clinical trial carried out in five hospitals in the United Kingdom evaluated women with singleton, vertex fetuses of 36 weeks of gestation or greater during labor. Continuous central fetal monitoring by computer analysis and online alerts (experimental arm) was compared with visual analysis (control arm). Fetal blood sampling and electrocardiographic ST waveform analysis were available in both arms. The primary outcome was incidence of newborn metabolic acidosis (pH less than 7.05 and base deficit greater than 12 mmol/L). Prespecified secondary outcomes included operative delivery, use of fetal blood sampling, low 5-minute Apgar score, neonatal intensive care unit admission, hypoxic-ischemic encephalopathy, and perinatal death. A sample size of 3,660 per group (N=7,320) was planned to be able to detect a reduction in the rate of metabolic acidosis from 2.8% to 1.8% (two-tailed α of 0.05 with 80% power). RESULTS: From August 2011 through July 2014, 32,306 women were assessed for eligibility and 7,730 were randomized: 3,961 to computer analysis and online alerts, and 3,769 to visual analysis. Baseline characteristics were similar in both groups. Metabolic acidosis occurred in 16 participants (0.40%) in the experimental arm and 22 participants (0.58%) in the control arm (relative risk 0.69 [0.36-1.31]). No statistically significant differences were found in the incidence of secondary outcomes. CONCLUSION: Compared with visual analysis, computer analysis of fetal monitoring signals with real-time alerts did not significantly reduce the rate of metabolic acidosis or obstetric intervention. A lower-than-expected rate of newborn metabolic acidosis was observed in both arms of the trial. CLINICAL TRIAL REGISTRATION: ISRCTN Registry, http://www.isrctn.com, ISRCTN42314164.

A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring.

BACKGROUND: Intrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related to fetal surveillance. Cardiotocographic (CTG) monitoring remains the basis of intrapartum surveillance, but its interpretation by healthcare professionals lacks reproducibility and the technology has not been shown to improve clinically important outcomes. The addition of fetal electrocardiogram analysis has increased the potential to avoid adverse outcomes, but CTG interpretation remains its main weakness. A program for computerised analysis of intrapartum fetal signals, incorporating real-time alerts for healthcare professionals, has recently been developed. There is a need to determine whether this technology can result in better perinatal outcomes. METHODS/DESIGN: This is a multicentre randomised clinical trial. Inclusion criteria are: women aged ≥ 16 years, able to provide written informed consent, singleton pregnancies ≥ 36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm) or continuous CTG monitoring as previously performed (control arm). Electrocardiographic monitoring and fetal scalp blood sampling will be available in both arms. The primary outcome measure is the incidence of fetal metabolic acidosis (umbilical artery pH < 7.05, BDecf > 12 mmol/L). Secondary outcome measures are: caesarean section and instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score < 7, neonatal intensive care unit admission, moderate and severe neonatal encephalopathy with a marker of hypoxia, perinatal death, rate of internal monitoring, tracing quality, and signal loss. Analysis will follow an intention to treat principle. Incidences of primary and secondary outcomes will be compared between groups. Assuming a reduction in metabolic acidosis from 2.8% to 1.8%, using a two-sided test with alpha = 0.05, power = 0.80, and 10% loss to follow-up, 8133 women need to be randomised. DISCUSSION: This study will provide evidence of the impact of intrapartum monitoring with computer analysis and real-time alerts on the incidence of adverse perinatal outcomes, intrapartum interventions and signal quality. (Current controlled trials ISRCTN42314164).

Liver function test and pregnancy.

The physiological changes in liver function in pregnancy are commonly transient, rarely permanent. Disorders arising in pregnancy, such as pre-eclampsia and eclampsia, acute fatty liver of pregnancy (AFLP), haemolysis, elevated liver enzyme and low platelets (HELLP) syndrome, cholestasis, hyperemesis gravidarum and isolated cases of raised liver enzymes can have serious implications. Proper interpretation of liver function tests (LFTs) at an early stage can lead to timely management and may reduce complications in both mother and fetus. Normal LFTs do not always mean that the liver is normal. A number of pitfalls can be encountered in the interpretation of basic blood LFTs. The commonly used LFTs primarily assess liver injury rather than hepatic function. Abnormal LFTs may indicate that something is wrong with the liver, and they can provide clues to the nature of the problem but this is not always the case. The various biochemical tests, their pathophysiology, and an approach to the interpretation of abnormal LFTs are discussed in this review. Commonly available tests include alanine transaminase, aspartate transaminase, alkaline phosphatase, bile acid, serum bilirubin, serum albumin and prothrombin time.

Can the reproducibility of fetal heart rate baseline estimation be improved?

OBJECTIVE: To evaluate the reproducibility of fetal heart rate (FHR) baseline estimation according to an objective and detailed definition presented in this article, by comparison with the FIGO guidelines' definition. STUDY DESIGN: Three hundred consecutively acquired FHR tracings, 150 from antepartum high-risk pregnancies and 150 from unselected intrapartum cases, were presented to nine experienced clinicians included in three different groups, for an estimation of the FHR baseline. The first group consisted of clinicians using the proposed definition, without previous training in its use. The second group consisted of clinicians using the proposed definition, where a previous training session was promoted. The third group consisted of clinicians using the FIGO guidelines' definition. Agreement in baseline estimation was evaluated using the kappa statistic, the proportions of agreement and the intra-class correlation coefficient. RESULTS: Using the baseline definition proposed in this article, agreement was significantly higher in the group with prior training in its use. This group also showed a trend towards a higher agreement than the one using the FIGO guidelines. CONCLUSION: The FHR baseline definition proposed in this article provides an extremely reproducible estimation when associated with prior training in its use.