The CErebro Placental RAtio as indicator for delivery following perception of reduced fetal movements, protocol for an international cluster randomised clinical trial; the CEPRA study.

BACKGROUND: Routine assessment in (near) term pregnancy is often inaccurate for the identification of fetuses who are mild to moderately compromised due to placental insufficiency and are at risk of adverse outcomes, especially when fetal size is seemingly within normal range for gestational age. Although biometric measurements and cardiotocography are frequently used, it is known that these techniques have low sensitivity and specificity. In clinical practice this diagnostic uncertainty results in considerable 'over treatment' of women with healthy fetuses whilst truly compromised fetuses remain unidentified. The CPR is the ratio of the umbilical artery pulsatility index over the middle cerebral artery pulsatility index. A low CPR reflects fetal redistribution and is thought to be indicative of placental insufficiency independent of actual fetal size, and a marker of adverse outcomes. Its utility as an indicator for delivery in women with reduced fetal movements (RFM) is unknown. The aim of this study is to assess whether expedited delivery of women with RFM identified as high risk on the basis of a low CPR improves neonatal outcomes. Secondary aims include childhood outcomes, maternal obstetric outcomes, and the predictive value of biomarkers for adverse outcomes. METHODS: International multicentre cluster randomised trial of women with singleton pregnancies with RFM at term, randomised to either an open or concealed arm. Only women with an estimated fetal weight ≥ 10th centile, a fetus in cephalic presentation and normal cardiotocograph are eligible and after informed consent the CPR will be measured. Expedited delivery is recommended in women with a low CPR in the open arm. Women in the concealed arm will not have their CPR results revealed and will receive routine clinical care. The intended sample size based on the primary outcome is 2160 patients. The primary outcome is a composite of: stillbirth, neonatal mortality, Apgar score < 7 at 5 min, cord pH < 7.10, emergency delivery for fetal distress, and severe neonatal morbidity. DISCUSSION: The CEPRA trial will identify whether the CPR is a good indicator for delivery in women with perceived reduced fetal movements. TRIAL REGISTRATION: Dutch trial registry (NTR), trial NL7557 . Registered 25 February 2019.

Dissatisfaction of women with induction of labour according to parity: Results of a population-based cohort study.

OBJECTIVE: To determine the factors associated with dissatisfaction in women whose labour was induced, according to parity. DESIGN: Prospective population-based cohort study. SETTING: Seven French perinatal health networks including 94 maternity units PARTICIPANTS: Among 3042 consecutive women who underwent induction of labour (IoL) with a live foetus from November 17 to December 20, 2015, in participating maternity units, this study included the 1453 who answered the self-administered questionnaire about their experience of IoL at two months post-delivery. MEASUREMENTS: The associations between women's dissatisfaction at two months post-delivery and the characteristics of their pregnancy, labour, and delivery were assessed with multivariable logistic regression models. Analyses were stratified for nulliparous and parous women. Multivariable mixed models were used to take a random effect for the maternity unit into account. FINDINGS: The response rate was 47.8% (n = 1453/3042). Overall, 30% of the nulliparous women were dissatisfied (n = 231/770) and 19.7% (n = 130/659) of the parous women. The specific independent determinants of dissatisfaction for nulliparous women were antenatal birth classes that failed to include discussion of IoL (OR: 2.68, 95% CI [1.37; 5.23]) and lack of involvement in the decision-making process (OR: 1.92, 95% CI [1.23; 3.02]). For the parous women, a specific determinant was a delivery that lasted more than 24 h (OR: 4.04, 95% CI [1.78; 9.14]). Determinants of maternal dissatisfaction common to both groups were unbearable vaginal discomfort (respectively, OR: 1.98, 95% CI [1.16; 3.37] and OR: 4.23, 95% CI [2.04; 8.77]), inadequate pain relief (respectively, OR: 5.55, 95% CI [3.48; 8.86] and OR: 9.17, 95% CI [5.24; 16.02]), lack of attention to requests (respectively OR: 3.81, 95% CI [2.35; 6.19] and OR: 5.01, 95% CI [2.38; 10.52]), caesarean delivery (respectively, OR: 5.55, 95% CI [3.41; 9.03] and OR: 4.61, 95% CI [2.02; 10.53]) and severe maternal complications (respectively, OR: 2.45, 95% CI [1.02; 5.88] and OR: 5.29, 95% CI [1.32; 21.21]). KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: To reduce dissatisfaction in nulliparous women, IoL should be discussed during antenatal birth classes and women should be made to feel that they shared in the medical decision to perform IoL. For parous women, care providers should inform them that the duration of delivery may exceed 24 h. Continuous support for all women during IoL should pay closer attention to vaginal discomfort, pain and women's requests. Postpartum discussions with mothers should be arranged to enable conversation about the experience of unexpected events.

[Elective induction of labour at 39 weeks; better than expectant management in low-risk women]. / Electief inleiden van de baring bij 39 weken.

The ARRIVE trial has shown that elective induction of labour at 39 weeks improves maternal and foetal outcomes in comparison with expectant management. Caesarean sections, hypertensive disorders and neonatal ventilator support were all found to be reduced after elective induction. The trial was performed in an American nulliparous low-risk population. Several American professional organizations have now adapted their recommendation on elective induction in nulliparous low-risk women. These organizations now suggest informing women about the potential benefits, and offer elective induction in a model of shared decision-making. In the Netherlands there has been some reluctance amongst professionals to address this issue. This might be related to a conservative obstetric approach and the Dutch obstetric model with its three separate levels of care. Nevertheless, this subject should be addressed in a scientific, professional and unprejudiced way, given the evidence and potential implications for the large group of low-risk women and neonates in the Netherlands.

Induction of Labor: An Overview of Guidelines.

IMPORTANCE: Induction of labor (IOL) is a common obstetric intervention that stimulates the onset of labor using artificial methods. OBJECTIVE: The aim of this study was to summarize and compare recommendations from 4 national or international medical societies on the IOL. EVIDENCE ACQUISITION: A descriptive review was conducted of major published guidelines on IOL: the American College of Obstetricians and Gynecologists' "Induction of Labor" and "Management of Late-Term and Postterm Pregnancies," the guidelines of the Society of Obstetricians and Gynaecologists of Canada (SOGC) on "Induction of Labour," those of the National Institute for Health and Care Excellence (NICE) on "Inducing Labour," and the World Health Organization's (WHO's) "Recommendations for Induction of Labour" and "WHO Recommendations: Induction of Labour at or Beyond Term." These guidelines were compared in terms of their recommendations on clinical indications and methods. RESULTS: Many similar indications and contraindications to IOL are identified between American College of Obstetricians and Gynecologists and SOGC, whereas NICE and WHO do not mention any contraindications. The timing of IOL in postterm pregnancies also differs among the guidelines. Regarding the methods of induction, all the medical societies recommend the use of membrane sweeping, mechanical methods, prostaglandins, and oxytocin, whereas NICE argues against the use of misoprostol for IOL. The American College of Obstetricians and Gynecologists and SOGC consider amniotomy a method of IOL, whereas NICE and WHO do not recommend it. All the guidelines also make similar recommendations regarding the management of uterine tachysystole in cases of IOL. CONCLUSIONS: The World Health Organization seems to be the most evidence-based guideline with recommendations based mainly on Cochrane reviews. The variation in the clinical indications and methods of IOL highlights the need to adopt an international consensus, which may help to optimize the quality of obstetric care and further promote evidence-based medicine.

[The ARRIVE Trial†: is it time to move towards a universal recommendation of induction of labor at term?] / Etude «â€ ARRIVE†¼â€ : vers une recommandation globale de déclenchement du travail d'accouchement à terme†?

Both cesarean surgery and induction of labor have become common procedures performed in all labor wards in an attempt to reduce adverse obstetrical and neonatal outcomes. Thus, recent evidence, led by the ARRIVE Trial, demonstrated that elective induction at 39 weeks reduced the rates of cesarean deliveries and of hypertensive disorders of pregnancy. However, some concerns must be addressed, as the benefits of universal policies have to be outweighed with the current circumstances of implementation, the economic impact, the number of procedures needed to effectively reduce complications, and, above all, women's perception towards this approach. Therefore, it would be interesting to explore individualization strategies, instead of general recommendations, to offer personalized care.

Afin de réduire les complications obstétricales et néonatales, la césarienne ainsi que le déclenchement de l'accouchement sont souvent pratiqués. Récemment, l'étude ARRIVE a démontré que le déclenchement à 39 semaines d'aménorrhée (SA) permet de diminuer le taux de césariennes et de complications hypertensives de la grossesse. Il reste à déterminer les avantages d'une recommandation universelle dans les circonstances actuelles, son impact économique, le nombre de déclenchements nécessaire pour réduire efficacement le taux des complications obstétricales et, surtout, la perception des femmes à l'égard de cette procédure. Finalement, il serait plus intéressant de développer des stratégies individualisées de prise en charge plutôt que des recommandations globales, afin d'offrir une prise en charge la plus personnalisée possible.

Inter-institutional variations in oxytocin augmentation during labour in German university hospitals: a national survey.

BACKGROUND: There are several international guidelines on oxytocin regimens for induction and augmentation of labour, but no agreement on a standardised regimen in Germany. This study collated and reviewed the oxytocin regimens used for labour augmentation in university hospitals, with the long-term aim of contributing to the development of a national clinical guideline. METHODS: Germany has 34 university hospital compounds, representing 39 maternity units. In this observational study we asked units to provide standard operational procedures on oxytocin augmentation during labour or provide the details in a structured survey. Data were collected on the dosage of oxytocin, type and volume of solutions used, indications and contraindications for use and discontinuation, case-specific administration, and on who developed the procedures. Findings were analysed descriptively. RESULTS: A total of 35 (90%) units participated in this study. Standard operating procedures were available in 24 units (69%), seven units (20%) did not have procedures and information was missing from four units (11%). Midwives participated in the development of standard operating procedures in 15 units (43%). Infusions were most commonly prepared using six units of oxytocin in 500 ml 0.9% normal saline solution (12 mU/ml). The infusions were started at 120 mU/hour and increased by 120 mU/hour at 20-min intervals up to a maximum dosage of 1200 mU/hour. The most common indication for use was delayed progress in labour. Infusions were stopped when uterine contractions became hypertonic and/or the fetal heart rate showed signs of distress. Most of the practices described aligned with international guidance. All units used reduced oxytocin dosages for women with a history of previous caesareans section, as recommended in the international guidelines, and restrictive use was advised in multiparous women. The main difference between units related to combined use of amniotomy and oxytocin, recommended by three guidelines but used in only four maternity units (11%). CONCLUSIONS: While there was considerable variation in the oxytocin augmentation procedures, most but not all practices used in these 35 German maternity units were comparable. Establishing a national guideline on the criteria for and administration of oxytocin for augmentation of labour would eliminate the observed differences and minimise risk of administration and medication error.

Woman-Centred Induction of Labour (the WOCIL project).

Induction of labour (IOL) is a common obstetric intervention. 32% of women are induced per year in our obstetric unit. We were experiencing delays in starting IOLs due to unit activity, protracted inpatient stay and dissatisfaction among staff and service users. We used quality improvement (QI) methodology to identify inefficiencies and root causes and used a bottom-up approach in planning improvements. After optimising our IOL processes, we introduced misoprostol vaginal insert (MVI) as it was faster acting than traditional dinoprostone. We compared 207 women who had MVI with 172 women who had dinoprostone prior to MVI introduction. There was a reduction of IOL start to delivery time, from a mean of 30 hours to 21 hours. Fewer women required oxytocin and of those who did, required oxytocin for fewer hours. We also found a reduction in caesarean section rates in women undergoing IOL, statistically significant in nulliparous women (41%-25%, p=0.03). There was a higher uterine tachysystole and hyperstimulation rate with MVI use and introduction should be accompanied by education of staff. We did not find any increase in neonatal admissions, maternal haemorrhage or other serious adverse events. In summary, MVI is a useful drug in helping high volume units with high IOL rates, reduced bed occupancy and improved flow of women. We would recommend a holistic QI approach to change management, as safe use of the drug requires optimisation of the IOL processes as well as staff engagement, due to rapid flow of women through the IOL pathway and increased hyperstimulation rates.

Women's experiences of induction of labour: Qualitative systematic review and thematic synthesis.

OBJECTIVES: To explore and synthesise evidence of women's experiences of induction of labour (IoL). DESIGN: Systematic review and thematic synthesis of peer-reviewed qualitative evidence. Relevant databases were searched from inception to the present day. Study quality was appraised using the Critical Appraisal Skills Programme (CASP) qualitative research appraisal tool. SETTING AND PARTICIPANTS: Low and high risk women who had experienced IoL in an inpatient or outpatient setting. FINDINGS: Eleven papers (representing 10 original studies) published between 2010 and 2018 were included for thematic synthesis. Four key analytical themes were identified: ways in which decisions regarding induction were made; women's ownership of the process; women's social needs when undergoing IoL; and the importance of place in the induction process. The review indicates that IoL is a challenging experience for women, which can be understood in terms of the gap between women's needs and the reality of their experience concerning information and decision-making, support, and environment. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Providing good quality appropriately timed information and supporting women's self-efficacy to be involved in decision-making around IoL may benefit women by facilitating a sense of ownership or control of labour. Compassionate support from significant others and healthcare professionals in a comfortable, private and safe environment should be available to all women.

Women's experiences of postterm induction of labor: A systematic review of qualitative studies.

BACKGROUND: Over the last decade, induction of labor (IOL) in postterm pregnancies has increased. Studies have shown the medical advantages of postterm IOL, but less is known about the perspectives of the pregnant women. This review aimed to summarize the current qualitative evidence on women's experience of postterm IOL. METHODS: A systematic literature search was performed in three databases. A total of 3193 publications were identified, but only eight studies met the inclusion criteria. Thematic analysis guided the data extraction and synthesis. The Confidence in the Evidence for Reviews of Qualitative research (CERQual) approach was used to assess confidence in the findings. RESULTS: Three major findings were identified. First, for some women, IOL required a shift in expectations because the hope of spontaneous labor had to be given up. Second, the IOL decision was considered a recommendation from health care professionals and was experienced as a nondecision. Finally, the induction process was experienced as a sequential set of steps where the women were expected to fit into the existing hospital organization. The CERQual assessment suggested moderate confidence in all findings. DISCUSSION: The negative experiences identified in this review can be greatly reduced by a communicative and patient-centered approach. To support informed choice and shared decision making, women need high-quality, unbiased information about IOL, alternative options, and potential outcomes, in addition to time for reflection on their personal values and preferences. Women may need a professionally initiated and supported opportunity to re-evaluate their hopes and expectations before IOL.

Timing induction of labour at 41 or 42 weeks? A closer look at time frames of comparison: A review.

BACKGROUND: Postterm pregnancy is associated with increased perinatal risk. The WHO defines postterm pregnancy as a pregnancy at or beyond 42 weeks + 0 days, though currently labour is induced at 41 weeks in many settings. Guidelines on timing of labour induction are frequently based on the Cochrane systematic review 'Induction of labour for improving birth outcomes for women at or beyond term' in which is concluded that a policy of induction of labour is associated with fewer adverse perinatal outcome and fewer Caesarean sections. However, the included trials differed regarding the timing of induction, ranging from 39 to beyond 42 weeks while the upper limit of expectant management exceeded a gestational age of 42 weeks in most studies. OBJECTIVE: to evaluate perinatal mortality, meconium aspiration syndrome and Caesarean section rate of trials comparing a policy of elective induction of labour and expectant management according to timeframes of comparison with a focus on studies within the 41-42 weeks' timeframe. DESIGN: Review. METHODS: The systematic review of Cochrane was used as a starting point for assessing relevant trials and a search was performed for additional recent trials. We evaluated incidence and causes of perinatal mortality, incidence of meconium aspiration syndrome and Caesarean section according to three time frames of comparison. We pooled estimates and heterogeneity was tested. The quality of the included trials was assessed using the Quality Assessment Tool for Quantative Studies (EPHPP). FINDINGS: In total 22 trials were included which had all different timeframes of comparison. Only one trial compared induction of labour at 41 weeks + 0-2 days with induction at 42 weeks + 0 days, three other trials compared induction of labour at 41 weeks + 0-6 days with induction at 42 weeks + 0-6 days. In 18 trials the comparison was outside the 41-42 weeks' timeframe: in six trials induction was planned ≤ 40 weeks and in another 12 trials expectant management was beyond 43 weeks. The incidence of potentially gestational age associated perinatal mortality between 41 and 42 weeks was 0/2.444 [0%] (induction) versus 4/2.452 [0.16%] (expectant management), NNT 613; 95%CI 613 - infinite. Two trials in the timeframe of comparison 41-42 weeks were available for evaluation of meconium aspiration syndrome (6/554 (induction) versus 14/554 (expectant management), RR 0.44; 95%CI 0.17-1.16). Three trials in the timeframe 41-42 weeks could be evaluated for Caesarean section, with different inclusion criteria regarding Bishop score. There was no significant difference in the Caesarean section rate 93/629 (induction) versus 106/629 (expectant management), RR 0.88; 95%CI 0.68-1.13. CONCLUSION: Evidence is lacking for the recommendation to induce labour at 41 weeks instead of 42 weeks for the improvement of perinatal outcome. More studies comparing both timeframes with an adequate sample size are needed to establish the optimal timing of induction of labour in late-term pregnancies.

Labour induction practices in France: A population-based declarative survey in 94 maternity units.

INTRODUCTION: In 2016, 22.0% of deliveries in France were induced. The current lack of high level of evidence data about the methods and indications for induction of labour has promoted heterogeneous and non-recommended practices. The extent of these different practices is not adequately known in France today, although they may influence perinatal outcomes. The objective of this study was to report current practices of induction of labour in France. MATERIAL AND METHODS: This study surveyed 94 maternity units in seven perinatal networks. A questionnaire was sent by email to either the department head or delivery room supervisor of these units to ask about their methods for induction and their attitudes in specific obstetric situations. RESULTS: The rate of induction varied between maternity units from 7.7% to 33% of deliveries. Most units used two (39.4%) or three or more (35.1%) agents for cervical ripening. In all, 87 (92.6%) units reported using dinoprostone as a vaginal slow-released insert, 59 units dinosprostone as a vaginal gel (62.8%) and 46 units a balloon catheter (48.9%). Only three units reported using vaginal misoprostol. Inductions without medical indication were reported by 71 (75.5%) maternity units, and 22 (23.4%) units even when the cervix was unfavourable. Obstetric attitudes in cases of breech presentation, previous caesareans, fetal growth restriction or macrosomia and prelabour rupture of the membranes varied widely. DISCUSSION: The variability of practices for induction of labour and the persistence of disapproved practices call for an assessment of the effectiveness and the safety of the different strategies.

Oxytocin Use in Labor: Legal Implications.

Oxytocin is one of the most commonly used medications in obstetrics and has been associated with claims of negligence in cases of adverse outcomes. Errors involving intravenous oxytocin administration for induction or augmentation of labor are most commonly dose related and include failure to avoid or treat tachysystole or failure to asses or treat a fetal heart rate pattern indicative of disruption in oxygenation. Clinicians should be knowledgeable regarding pharmacokinetics of oxytocin and the effect of uterine contractions on fetal oxygenation as well as safe titration of oxytocin to achieve the desired effect while minimizing harm.

WHO recommendations: induction of labour at or beyond term

Induction of labour is defined as the process of artificially stimulating the uterus to start labour. It is usually performed by administering oxytocin or prostaglandins to the pregnant woman or by manually rupturing the amniotic membranes. Induction of labour is not riskfree, and many women find it uncomfortable. Over the past several decades, the incidence of inducing labour for shortening the duration of pregnancy has continued to rise. In highincome countries, the proportion of infants delivered at term following induction of labour can be as high as one in four births. In low- and middle-income countries the rates are generally lower, but in some settings, they can be as high as those observed in high-income countries. Improving care for women around the time of childbirth is a necessary step towards the achievement of the health targets of the Sustainable Development Goals (SDGs). Efforts to prevent and reduce morbidity and mortality during pregnancy and childbirth could help address the profound inequities in maternal and perinatal health globally. To achieve these aims, healthcare providers, health managers, policy makers and other stakeholders need up-todate and evidence-based recommendations to inform clinical policies and practices. In 2017, the Executive Guideline Steering Group (GSG) on the World Health Organization's (WHO) maternal and perinatal health recommendations prioritized the updating of the existing WHO recommendations on the induction of labour at or beyond term in response to important new evidence on this intervention. These recommendations are arevalidation of the previous recommendations issued in 2011 in the WHO recommendations on induction of labour.