Substandard or disrespectful care during labour should be of serious concern for healthcare professionals, as it can affect one of the most important events in a woman’s life. Substandard care refers ...to the use of interventions that are not considered best-practice, to the inadequate execution of interventions, to situations where best-practice interventions are withheld from patients, or there is lack of adequate informed consent. Disrespectful care refers to forms of verbal and non-verbal communication that affect patients’ dignity, individuality, privacy, intimacy, or personal beliefs. There are many possible underlying causes for substandard and disrespectful care in labour, including difficulties in modifying behaviours, judgmental or paternalistic attitudes, personal interests and individualism, and a human tendency to make less arduous, less difficult, or less stressful clinical decisions. The term “obstetric violence” is used in some parts of the world to describe various forms of substandard and disrespectful care in labour, but suggests that it is mainly carried out by obstetricians and is a serious form of aggression, carried out with the intent to cause harm. We believe that this term should not be used, as it does not help to identify the underlying problem, its causes, or its correction. In addition, it is generally seen by obstetricians and other healthcare professionals as an unjust and offensive term, generating a defensive and less collaborative mindset. We reach out to all individuals and institutions sharing the common goal of improving women’s experience during labour, to work together to address the underlying causes of substandard and disrespectful care, and to develop common strategies to deal with this problem, based on mutual comprehension, trust and respect
In the past century, some areas of obstetric including intrapartum care have been slow to benefit from the dramatic advances in technology and medical care. Although fetal heart rate monitoring ...(cardiotocography) became available a half century ago, its interpretation often differs between institutions and countries, its diagnostic accuracy needs improvement, and a technology to help reduce the unnecessary obstetric interventions that have accompanied the cardiotocography is urgently needed.
During the second half of the 20th century, key findings in animal experiments captured the close relationship between myocardial glycogenolysis, myocardial workload, and ST changes, thus demonstrating that ST waveform analysis of the fetal electrocardiogram can provide information on oxygenation of the fetal myocardium and establishing the physiological basis for the use of electrocardiogram in intrapartum fetal surveillance.
Six randomized controlled trials, 10 meta-analyses, and more than 20 observational studies have evaluated the technology developed based on this principle. Nonetheless, despite this intensive assessment, differences in study protocols, inclusion criteria, enrollment rates, clinical guidelines, use of fetal blood sampling, and definitions of key outcome parameters, as well as inconsistencies in randomized controlled trial data handling and statistical methodology, have made this voluminous evidence difficult to interpret. Enormous resources spent on randomized controlled trials have failed to guarantee the generalizability of their results to other settings or their ability to reflect everyday clinical practice.
The latest meta-analysis used revised data from primary randomized controlled trials and data from the largest randomized controlled trials from the United States to demonstrate a significant reduction of metabolic acidosis rates by 36% (odds ratio, 0.64; 95% confidence interval, 0.46–0.88) and operative vaginal delivery rates by 8% (relative risk, 0.92; 95% confidence interval, 0.86–0.99), compared with cardiotocography alone.
1. Oxytocin for induction or augmentation of labor should not be started when there is a previous scar on the body of the uterus (such as previous classical cesarean section, uterine perforation or ...myomectomy when uterine cavity is reached) or in any other condition where labor or vaginal delivery are contraindicated. (Moderate quality evidence +++-; Strong recommendation).
2. Oxytocin should not be started before at least 1 h has elapsed since amniotomy, 6 h since the use of dinoprostone (30 min if vaginal insert) and 4 h since the use of misoprostol (Low quality evidence ++- -; Moderate recommendation).
3. Cardiotocography (CTG) should be performed and a normal pattern without tachysystole should be documented for at least 30 min before oxytocin is used. Continuous CTG, with adequate monitoring of both fetal heart rate and uterine contractions, should be maintained for as long as oxytocin is used, and thereafter until delivery (Low ++- - to moderate +++- quality evidence; Strong recommendation).
4. For labor induction, at least 1-h should be allowed after amniotomy before oxytocin infusion is started, to evaluate whether adequate uterine contractility has meanwhile ensued. For augmentation of labor, if the membranes are intact and there are conditions for a safe amniotomy, the latter should be considered before oxytocin is started (Very low quality evidence +- --; Weak recommendation).
5. Oxytocin should be administered intravenously using the following regimen: 5 IU oxytocin diluted in 500 mL of 0.9% normal saline (NaCl) (each mL contains 10 mIU of oxytocin), in an infusion pump at increasing rates, as shown in
Table 1
, until a frequency of 3-4 contractions per 10 min is reached, a non-reassuring CTG pattern ensues, or maximum rates are reached (Low quality evidence ++ - -; Strong recommendation). If the frequency of contractions exceeds 5 in 10 min, the infusion rate should be reduced, even if a normal CTG pattern is present. With a non-reassuring CTG pattern, urgent clinical assessment by an obstetrician is indicated, and strong consideration should be given to reducing or stopping the oxytocin infusion. The minimal effective dose of oxytocin should always be used. (Low ++- - to Moderate +++- - quality evidence; Strong recommendation).
6. Use of oxytocin for induction and augmentation of labor should be regularly audited (Low quality evidence ++--; Strong recommendation).
In high-resource countries, adverse perinatal outcomes are currently rare in term, non-malformed fetuses, undergoing labor, but they remain a leading cause of medico-legal dispute. Precise ...terminology is important to describe situations related to inadequate fetal oxygenation in labor, to ensure appropriate communication between healthcare professionals and adequate transmission of information to parents. This position statement provides consensus definitions from European perinatologists and midwives regarding the most appropriate terminology to describe situations related to inadequate fetal oxygenation in labor: suspected fetal hypoxia, severe newborn acidemia, newborn metabolic acidosis, and hypoxic-ischemic encephalopathy. It also identifies terms that are imprecise or nonspecific to this situation, and should therefore be avoided by healthcare professionals: fetal well-being, fetal stress, fetal distress, non-reassuring fetal state, and birth asphyxia.
Background: Oxytocin is effective in reducing labor duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labor. ...We assessed the impact of discontinuing oxytocin during active labor on neonatal morbidity. Methods: STOPOXY was a multicenter, randomized, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4cm dilation were randomly assigned, in a 1:1 ratio to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6cm) or continuous oxytocin (administration of oxytocin is continued until delivery). Randomization was stratified by center and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth <7.10 and/or a base excess >10mmol/L and/or umbilical arterial lactates>7 mmol/L and/or a 5-minute Apgar score <7 and/or admission in neonatal intensive care unit. Results: Out of the 2459 participants randomized between January 13, 2020, and January 24, 2022, 2170 were eligible to receive the intervention and were analyzed. The primary outcome occurred in 102 of 1067 women (9.6%, 95%CI(7.9 to 11.5)) in the discontinuous oxytocin group and in 101 of 1103 women (9.2%, 95%CI(7.6 to 11.0)) in the control group, absolute difference 0.004, 95%CI(-0.021 to 0.029); RR 1.0, 95%CI(0.8 to 1.4). There were no clinically significant differences in adverse events between the two groups of the safety population. Interpretation: Among participants receiving oxytocin in early labor, discontinuing oxytocin when active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared to continuous oxytocin.
Oxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed ...to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity.
STOPOXY was a multicentre, randomised, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4 cm dilation were randomly assigned 1:1 to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6 cm) or continuous oxytocin (administration of oxytocin continued until delivery). Randomisation was stratified by centre and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth less than 7·10, a base excess greater than 10 mmol/L, umbilical arterial lactates greater than 7 mmol/L, a 5-min Apgar score less than 7, or admission to the neonatal intensive care unit. Efficacy and safety was assessed in participants who were randomly assigned (excluding those who withdrew consent or were deemed ineligible after randomisation) and had reached a cervical dilation of at least 6 cm. This trial is registered with ClinicalTrials.gov, NCT03991091.
Of 2459 participants randomly assigned between Jan 13, 2020, and Jan 24, 2022, 2170 were eligible to receive the intervention and were included in the final modified intention-to-treat analysis. The primary outcome occurred for 102 (9·6%) of 1067 participants (95% CI 7·9 to 11·5) in the discontinuous oxytocin group and for 101 (9·2%) of 1103 participants (7·6 to 11·0) in the continuous oxytocin group; absolute difference 0·4% (95% CI –2·1 to 2·9); relative risk 1·0 (95% CI 0·8 to 1·4). There were no clinically significant differences in adverse events between the two groups of the safety population.
Among participants receiving oxytocin in early labour, discontinuing oxytocin when the active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared with continuous oxytocin.
French Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique–Hôpitaux de Paris.
Oxytocin is effective in reducing labor duration, but can be associated with fetal and maternal complications such as neonatal acidosis and post-partum hemorrhage. When comparing discontinuing ...oxytocin in the active phase with continuing oxytocin infusion, previous studies were underpowered to show a reduction in neonatal morbidity. Thus, we aim at evaluating the impact of discontinuing oxytocin during the active phase of the first stage of labor on the neonatal morbidity rate.
STOPOXY is a multicenter, randomized, open-label, controlled trial conducted in 20 maternity units in France. The first participant was recruited January 17th 2020. The trial includes women with a live term (≥37 weeks) singleton, in cephalic presentation, receiving oxytocin before 4 cm, after an induced or spontaneous labor. Women aged < 18 years, with a lack of social security coverage, a scarred uterus, a multiple pregnancy, a fetal congenital malformation, a growth retardation <3rd percentile or an abnormal fetal heart rate at randomization are excluded. Women are randomized before 6 cm when oxytocin is either continued or discontinued. Randomization is stratified by center and parity. The primary outcome, neonatal morbidity is assessed using a composite variable defined by an umbilical arterial pH at birth < 7.10 and/or a base excess > 10 mmol/L and/or umbilical arterial lactates> 7 mmol/L and/or a 5 min Apgar score < 7 and/or admission in neonatal intensive care unit. The primary outcome will be compared between the two groups using a chi-square test with a p-value of 0.05. Secondary outcomes include neonatal complications, duration of active phase, mode of delivery, fetal and maternal complications during labor and delivery, including cesarean delivery rate and postpartum hemorrhage, and birth experience. We aim at including 2475 women based on a reduction in neonatal morbidity from 8% in the control group to 5% in the experimental group, with a power of 80% and an alpha risk of 5%.
Discontinuing oxytocin during the active phase of labor could improve both child health, by reducing moderate to severe neonatal morbidity, and maternal health by reducing cesarean delivery and postpartum hemorrhage rates.
Clinical trials NCT03991091 , registered June 19th, 2019.